Director, Quality Product Strategy (Devices)

📍 Job Overview

Job Title: Director, Quality Product Strategy (Devices)

Company: MSD

Location: Rahway, New Jersey, United States of America; Hangzhou, Zhejiang, China; Ballydine, Tipperary, Ireland; Saitama, Saitama, Japan; Haarlem, North Holland, Netherlands; Singapore, Singapore; Millsboro, Delaware, United States of America; Ames, Iowa, United States of America; De Soto, Kansas, United States of America; Worthington, Minnesota, United States of America; Elkhorn, Nebraska, United States of America; Durham, North Carolina, United States of America; Wilson, North Carolina, United States of America; West Point, Pennsylvania, United States of America; Elkton, Virginia, United States of America

Job Type: FULL_TIME

Category: Quality Operations / Product Strategy

Date Posted: March 28, 2026

Experience Level: Mid-Senior Level (5-10 years indicated, but requirements suggest more)

Remote Status: Hybrid

🚀 Role Summary

• Drive the end-to-end pharmaceutical product quality strategy for devices within MSD's manufacturing and testing network.

• Ensure the development and execution of robust quality strategies to support new product launches and maintain uninterrupted supply of commercial products.

• Act as a key member of the Value Chain Management Team (VCMT) and provide franchise support for late-stage pipeline quality activities and inline quality issue resolution.

• Lead and/or participate in executing strategic goals aligned with the Development and Commercialization Team (DCT) and Platform/Product Councils.

📝 Enhancement Note: While the AI experience level suggests 5-10 years, the explicit requirement of "minimum of twelve (12) years of experience" indicates this role is for a more senior professional. The title "Director" also aligns with this higher experience expectation. This role is crucial for ensuring product quality and supply chain integrity, deeply embedding it within the core of GTM operations from a quality assurance perspective.

📈 Primary Responsibilities

• Lead the development and oversight of product quality strategic elements for pharmaceutical franchises, aligning short and long-term goals with DCT/VCMT/Platform/Product Councils.

• Define strategic elements including inspection and launch readiness for pipeline products, testing and quality strategies (product analytical strategy), risk mitigation, issue resolution, network expansion, and supply chain robustness at a global franchise level.

• Serve as a quality designee for global product quality as needed, representing the company's commitment to high standards.

• Ensure prioritization, progress tracking, and escalation of quality-related strategic goals (including strategy, efficiency, and compliance) through periodic reviews and dashboards across products and manufacturing/testing sites.

• Lead and/or participate in executing VCMT/DCT-aligned strategic goals with stakeholders and partners across Research & Development and Manufacturing divisions.

• Review and approve franchise-level documentation, including Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Reviews, Control Strategies, franchise-level protocols/reports, filing/license submissions, franchise-level regulatory observation responses, RTQs, franchise-level change control, and site/multi-site investigations.

• Lead or coordinate Quality Working Group meetings for the franchise and serve as the Quality Representative to DCT/VCMT and associated working groups, collaborating with Quality leads to resolve supply chain quality issues.

• Collaborate with QMS Chapter leads and document owners to define, refine, and standardize quality requirements, identifying gaps in QMS critical for consistent interpretation of regulations and driving standardization/continuous improvement of QMS documents.

• Track key quality metrics (e.g., change control, complaints) for the franchise and evaluate the franchise's Annual Product Review for supply chain trends, escalating risks as necessary.

• Actively participate in and escalate issues/risks to Quality sponsors and via IRM as required, identifying the need for and supporting the development of Analytical Siting decisions.

• Monitor and mitigate franchise Quality risks and participate in inspections, championing Permanent Inspection Readiness (PIR) for the product program.

📝 Enhancement Note: The responsibilities highlight a strong emphasis on strategic planning, cross-functional leadership, and operational execution within a highly regulated pharmaceutical environment. This role requires a deep understanding of GTM processes from a quality and compliance perspective, ensuring that product quality strategies directly support market access and supply chain continuity.

🎓 Skills & Qualifications

Education:

Experience:

• Minimum of twelve (12) years of experience, including quality oversight roles with technical elements or technical operations roles.

• Minimum of two (2) years of direct experience with supply chain strategy or technical elements such as change controls, investigations, or process documentation (e.g., protocols, CPV).

Required Skills:

• Enterprise Leadership Skills: Demonstrated ability to lead and influence across multiple functions and sites.

• Value Chain Management Team (VCMT) / Development and Commercialization Team (DCT) Participation: Experience collaborating within these strategic governance bodies.

• Product Quality Strategy: Deep understanding of developing and implementing quality strategies for pharmaceutical products, including devices.

• Inspection Readiness: Proven ability to prepare for and successfully navigate regulatory inspections.

• Risk Mitigation & Issue Resolution: Expertise in identifying, assessing, and resolving quality-related risks and issues.

• Supply Chain Robustness: Experience in enhancing the resilience and reliability of global supply chains.

• Regulatory Submissions: Familiarity with requirements for filing/license submissions and responding to regulatory observations.

• Change Control & Investigations: Proficiency in managing change control processes and conducting thorough investigations.

• Quality Working Group Leadership: Ability to lead cross-functional quality teams.

• QMS Standardization: Experience in defining, refining, and standardizing Quality Management System requirements.

• Analytical Thinking: Strong ability to analyze complex data and situations to drive informed decisions.

• Collaboration & Cross-Functional Work: Proven success working effectively with diverse teams and stakeholders across different departments and geographies.

• Communication: Excellent written and verbal communication skills for external-facing communications and stakeholder engagement.

• Global Supply Chain Strategy: Understanding of strategies to ensure quality and compliance across global supply networks.

• Quality Assurance (QA) & Quality Mindset: Comprehensive knowledge of QA principles and a strong commitment to quality in all aspects of work.

• Entrepreneurship/Innovation: Ability to confront difficult issues, offer creative alternatives, and take action to meet patient, customer, and organizational needs.

• Decision Making/Influence: Skill in identifying and understanding problems, gathering and analyzing information, establishing decision criteria, and influencing others to gain acceptance of ideas and commitment to action.

• Growth/Development/Change: Adaptability to new knowledge, skills, and environments; ability to modify behavior to improve impact and adapt to significant changes.

• Networking/Inclusion: Ability to build partnerships and leverage relationships within and across work groups to achieve results, working effectively across diverse cultures, styles, and perspectives.

• Execution Excellence/Ownership/Inspiration: Proactiveness, setting high performance standards, effective communication, and active listening.

Preferred Skills:

• Direct experience with medical devices specific quality strategies.

📝 Enhancement Note: The required skills blend technical quality expertise with robust leadership and strategic capabilities. For operations professionals, this translates to a need to demonstrate how their experience in process optimization, data analysis, and cross-functional project management directly contributes to product quality and market readiness, aligning with the GTM objectives of reliable supply and successful product launches.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Process Optimization Case Studies: Showcase examples of how you have identified and improved quality-related processes, demonstrating quantifiable improvements in efficiency, compliance, or risk reduction.

• Strategic Planning Documentation: Include examples of strategic plans you've developed or contributed to, particularly those related to product launches, supply chain robustness, or network expansion.

• QMS Enhancement Examples: Present instances where you've contributed to defining, refining, or standardizing Quality Management System requirements, highlighting the impact on consistency and regulatory adherence.

• Risk Management Frameworks: Demonstrate your approach to identifying, assessing, and mitigating quality risks, potentially through documented risk assessments or mitigation plans.

Process Documentation:

• Comparability Plans & Protocols: Evidence of experience in developing and approving comparability plans and associated protocols, crucial for product strategy and post-approval changes.

• Change Control & Investigation Reports: Examples of managing franchise-level change control processes and leading/contributing to site or multi-site investigations.

• Annual Product Review Analysis: Showcase your approach to evaluating Annual Product Reviews for trend identification and risk escalation.

• Standard Operating Procedures (SOPs) & Work Instructions: Demonstrate familiarity with developing, reviewing, or implementing SOPs and work instructions that govern quality processes.

📝 Enhancement Note: For operations professionals applying to this role, the portfolio should emphasize their ability to translate strategic quality objectives into actionable operational processes. This includes demonstrating proficiency in documentation, risk management, and cross-functional process improvement, directly supporting the GTM goal of reliable product availability and market compliance.

💵 Compensation & Benefits

Salary Range: $173,200.00 - $272,600.00 USD per year.

Benefits:

• Comprehensive package including:

  • Medical, Dental, and Vision Healthcare.
  • Retirement benefits, including a 401(k) plan.
  • Paid holidays.
  • Vacation time.
  • Compassionate and sick days.

• Additional information available at https://jobs.merck.com/us/en/compensation-and-benefits.

Working Hours:

• Standard 40 hours per week, 1st shift (Day).

• Hybrid work model: 3 days on-site per week (Monday-Thursday), with Friday designated as a remote-working day, unless business-critical tasks require on-site presence. This model may not apply to all roles, and specific site or organizational variations may occur.

📝 Enhancement Note: The salary range provided is for the US market. For international locations, salary expectations would vary significantly based on local market rates, cost of living, and specific regional compensation benchmarks for director-level quality strategy roles within the pharmaceutical industry. The inclusion of annual bonus and long-term incentives is standard for senior leadership roles and should be factored into total compensation expectations.

🎯 Team & Company Context

🏢 Company Culture

Industry: Pharmaceutical and Biotechnology. MSD (known as Merck & Co., Inc. in the US and Canada) is a global leader dedicated to discovering, developing, manufacturing, and marketing a broad range of innovative health products, including medicines and vaccines.

Company Size: Large enterprise (indicated by the extensive employee count and global presence).

Founded: The company has a long and rich history, with its origins tracing back to 1891.

Team Structure:

• This role operates within a matrixed global organization, collaborating closely with Quality, Manufacturing, Research & Development, Commercialization, and Supply Chain teams.

• It involves membership in key strategic governance bodies like the Value Chain Management Team (VCMT) and Development and Commercialization Team (DCT).

Methodology:

• Data-Driven Decision Making: Emphasis on using data from quality reviews, inspections, and metrics to inform strategic decisions and identify trends.

• Process Optimization: Continuous improvement of quality management systems and operational processes to enhance efficiency, compliance, and product quality.

• Risk-Based Approach: Proactive identification, assessment, and mitigation of quality risks throughout the product lifecycle.

• Cross-Functional Collaboration: a strong focus on working collaboratively across diverse teams and geographies to achieve shared objectives.

Company Website: https://jobs.msd.com/gb/en and https://www.msd.com/

📝 Enhancement Note: MSD's culture is characterized by a commitment to scientific innovation, patient well-being, and ethical conduct. For operations professionals, this translates to a highly regulated environment where quality, compliance, and meticulous execution are paramount. The emphasis on collaboration and data-driven decisions aligns with modern GTM operational best practices.

📈 Career & Growth Analysis

Operations Career Level: Director level, signifying significant responsibility and strategic influence within the Quality and Supply Chain functions. This role is critical for ensuring the integrity and continuity of product supply and market access.

Reporting Structure: The role likely reports into a senior leader within Quality or Manufacturing Operations, with significant dotted-line reporting and collaboration with VCMT and DCT leadership.

Operations Impact: This role directly impacts the company's ability to bring innovative products to market and maintain reliable supply for existing ones. Success here ensures regulatory compliance, patient safety, and commercial viability by overseeing product quality strategies from development through commercialization.

Growth Opportunities:

• Leadership Advancement: Potential to move into higher executive leadership roles within Quality, Manufacturing, or Global Supply Chain management.

• Specialization: Deepen expertise in specific product areas (e.g., small molecule, devices) or quality system domains.

• Global Exposure: Opportunity to work on global initiatives, gain experience across different regulatory environments, and lead international teams.

• Strategic Project Leadership: Lead major strategic projects related to network expansion, supply chain resilience, or new product introductions.

📝 Enhancement Note: For operations professionals, this role represents a significant step into strategic leadership within a critical function. Growth opportunities are tied to demonstrating leadership in complex, regulated environments and driving impact on global product supply and quality, directly contributing to the company's GTM success.

🌐 Work Environment

Office Type: Hybrid work model, with a mix of on-site and remote work. The on-site component is designed for collaboration and team interaction.

Office Location(s): The role is open to multiple global locations including Rahway (NJ), Millsboro (DE), Ames (IA), De Soto (KS), Worthington (MN), Elkhorn (NE), Durham (NC), Wilson (NC), West Point (PA), Elkton (VA) in the US, as well as Ballydine (Ireland), Hangzhou (China), Saitama (Japan), and Haarlem (Netherlands), and Singapore. This offers flexibility for candidates in various regions.

Workspace Context:

• Collaborative Environment: The hybrid model encourages collaboration, with designated on-site days for team meetings, strategic discussions, and cross-functional alignment.

• Technology Enabled: Access to advanced systems and tools for quality management, data analysis, project management, and communication is expected.

• Global Interaction: Frequent interaction with colleagues and stakeholders across different time zones and cultures, requiring strong remote collaboration skills.

Work Schedule: Standard 40-hour work week, with flexibility offered through the hybrid model. Friday is designated as a remote working day, supporting work-life balance while ensuring critical business needs are met.

📝 Enhancement Note: The hybrid work environment is a key aspect for operations professionals, balancing the need for in-person collaboration on strategic initiatives with the flexibility of remote work for focused tasks and data analysis. The extensive list of potential locations suggests a global team structure where remote collaboration tools are essential.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: Likely conducted by an HR representative or recruiter to assess basic qualifications and fit.

• Hiring Manager Interview: Focus on assessing leadership skills, strategic thinking, and direct experience related to product quality strategy and GTM support.

• Panel Interviews: May involve key stakeholders from R&D, Manufacturing, Supply Chain, and other Quality functions to evaluate cross-functional collaboration and depth of technical knowledge.

• Case Study/Presentation: Candidates may be asked to present on a past success in developing or executing a quality strategy, managing a complex issue, or improving a supply chain process.

• Executive/Senior Leader Interview: Final round to assess strategic alignment, cultural fit, and overall leadership potential.

Portfolio Review Tips:

• Quantify Impact: For each portfolio item, clearly articulate the problem, your solution, and the measurable outcomes (e.g., % reduction in deviations, improved inspection scores, successful launch metrics, cost savings).

• Showcase Strategic Thinking: Highlight how your work contributed to broader GTM objectives, such as market access, supply chain reliability, or competitive advantage.

• Demonstrate Leadership: Provide examples of how you led cross-functional teams, influenced stakeholders, and drove consensus on quality strategies.

• Address Regulatory Compliance: Ensure your examples demonstrate a strong understanding of and adherence to pharmaceutical regulations (e.g., FDA, EMA).

• Tailor to MSD: Research MSD's current product portfolio, strategic priorities, and recent quality initiatives to tailor your examples and demonstrate relevant insights.

Challenge Preparation:

• Strategic Quality Planning: Be prepared to discuss how you would approach developing a quality strategy for a new device launch or addressing a significant quality issue in a global supply chain.

• Stakeholder Management: Anticipate questions on how you would manage conflicting priorities between R&D, Manufacturing, and Commercial teams regarding quality requirements.

• Process Improvement Scenarios: Prepare to outline a step-by-step approach to improving a complex quality process, such as change control or CAPA management.

• Data Analysis & Interpretation: Be ready to discuss how you use data to identify quality trends, assess risks, and make strategic recommendations.

📝 Enhancement Note: Operations candidates should focus on showcasing their ability to link quality processes directly to business outcomes and GTM success. Demonstrating a strategic, data-driven approach to quality management, along with strong leadership and collaboration skills, will be key to impressing the interview panel.

🛠 Tools & Technology Stack

Primary Tools:

• Quality Management Systems (QMS): Experience with enterprise QMS software (e.g., Veeva QualityDocs, MasterControl, Sparta Systems TrackWise) for document control, change management, CAPA, and deviation management.

• Enterprise Resource Planning (ERP) Systems: Familiarity with ERP systems (e.g., SAP) for supply chain visibility, inventory management, and manufacturing operations.

• Collaboration Platforms: Proficiency with tools like Microsoft Teams, Slack, or similar for communication and project coordination.

• Project Management Software: Experience with tools such as Jira, Asana, or Microsoft Project for managing strategic initiatives and timelines.

Analytics & Reporting:

• Business Intelligence (BI) Tools: Experience with BI platforms (e.g., Tableau, Power BI, QlikView) for developing dashboards and reports on quality metrics, supply chain performance, and regulatory compliance.

• Statistical Analysis Software: Familiarity with tools like JMP, Minitab, or SAS for in-depth data analysis, statistical process control (SPC), and trend analysis.

• Data Warehousing & Databases: Understanding of data structures and experience querying databases (e.g., SQL) for data extraction and analysis.

CRM & Automation:

• Customer Relationship Management (CRM) Systems: While not directly a CRM role, understanding how product quality impacts customer satisfaction and market access is crucial. Familiarity with CRM principles and data flow is beneficial.

• Process Automation Tools: Awareness of automation technologies or principles that can enhance quality processes (e.g., workflow automation within QMS, robotic process automation for data entry).

• Integration Platforms: Understanding of how different systems (QMS, ERP, LIMS) integrate to ensure seamless data flow and operational efficiency.

📝 Enhancement Note: For operations professionals, highlighting proficiency in these tools, especially those related to QMS, data analytics, and supply chain visibility, will be critical. Demonstrating an ability to leverage technology to drive quality improvements and support GTM objectives is a significant advantage.

👥 Team Culture & Values

Operations Values:

• Patient Focus: A commitment to ensuring patient safety and well-being through the highest standards of product quality.

• Integrity: Upholding ethical standards and transparency in all operations and decision-making.

• Excellence: Striving for continuous improvement and high performance in all aspects of work, from strategy development to execution.

• Innovation: Encouraging creative problem-solving and the adoption of new approaches to enhance product quality and operational efficiency.

• Collaboration: Fostering a team-oriented environment where diverse perspectives are valued and leveraged to achieve common goals.

Collaboration Style:

• Cross-Functional Partnership: A strong emphasis on building and maintaining collaborative relationships with R&D, Manufacturing, Commercial, Regulatory Affairs, and Supply Chain teams.

• Open Communication: Encouraging open dialogue, active listening, and constructive feedback to drive alignment and resolve issues effectively.

• Data-Informed Discussions: Using data and analytical insights to guide discussions and build consensus among diverse stakeholders.

• Global Mindset: Working effectively with colleagues from different cultural backgrounds, respecting varied perspectives and approaches to problem-solving.

📝 Enhancement Note: Operations professionals should align their responses and experiences with these values, emphasizing how their work directly contributes to patient safety, ethical operations, and collaborative problem-solving. Demonstrating a global mindset and data-driven approach will resonate well within MSD's culture.

⚡ Challenges & Growth Opportunities

Challenges:

• Global Regulatory Landscape: Navigating complex and evolving regulatory requirements across multiple international markets.

• Supply Chain Complexity: Managing a global supply chain with diverse manufacturing and testing sites, each with unique operational nuances and quality standards.

• Balancing Innovation and Compliance: Ensuring that the drive for new product launches and process improvements does not compromise stringent regulatory compliance.

• Cross-Functional Alignment: Achieving consensus and driving action among diverse stakeholders with potentially competing priorities.

• Data Integration and Analysis: Effectively integrating data from disparate systems to gain comprehensive insights into product quality and supply chain performance.

Learning & Development Opportunities:

• Advanced Quality Systems Training: Opportunities to deepen knowledge in specific areas of pharmaceutical quality management and regulatory affairs.

• Leadership Development Programs: MSD offers programs to enhance leadership capabilities, strategic thinking, and executive presence.

• Industry Conferences & Seminars: Participation in key industry events to stay abreast of regulatory changes, technological advancements, and best practices.

• Cross-Functional Rotations/Projects: Potential to engage in projects that offer exposure to different parts of the organization, broadening understanding of the entire product lifecycle.

• Mentorship Programs: Access to mentorship from senior leaders within MSD to guide career development and strategic thinking.

📝 Enhancement Note: For operations professionals, understanding these challenges and growth opportunities is key to framing their experience. They should highlight how they have successfully navigated similar complexities and are eager to develop further in areas critical to pharmaceutical quality and supply chain management.

💡 Interview Preparation

Strategy Questions:

• "Describe your approach to developing a comprehensive quality strategy for a new pharmaceutical device launch, considering global regulatory requirements and market access timelines."

  • Preparation: Focus on a structured approach, including risk assessment, defining critical quality attributes, establishing control strategies, and planning for regulatory submissions. Connect to GTM objectives of timely market entry and patient access.

• "How would you ensure alignment and drive execution of strategic quality goals across multiple global manufacturing and testing sites, each with potentially different operational maturity levels?"

  • Preparation: Emphasize communication strategies, stakeholder engagement, establishing clear metrics and KPIs, leveraging VCMT/DCT structures, and implementing standardized processes.

• "Walk us through a complex quality issue you managed in a global supply chain. What was your process for investigation, resolution, and preventing recurrence? What was the impact on supply continuity?"

  • Preparation: Use the STAR method (Situation, Task, Action, Result). Quantify the impact on supply continuity and market availability. Highlight your analytical and problem-solving skills.

Company & Culture Questions:

• "What do you know about MSD's commitment to quality and innovation, and how do you see your role contributing to that?"

  • Preparation: Research MSD's mission, values, recent product news, and quality initiatives. Connect your experience to their stated goals of patient well-being and scientific advancement.

• "Describe your experience working within cross-functional teams. How do you build consensus and manage differing opinions, particularly when quality requirements are at stake?"

  • Preparation: Provide specific examples of collaboration, conflict resolution, and influencing skills. Highlight your ability to communicate technical information to non-technical audiences and vice-versa.

• "How do you measure the success of a quality strategy, and what KPIs would you prioritize for this role?"

  • Preparation: Discuss metrics related to inspection readiness, compliance rates, complaint trends, deviation reduction, successful product launches, and supply chain reliability.

Portfolio Presentation Strategy:

• Structure Your Narrative: For each portfolio example, clearly define the challenge, your role and actions, the innovative solutions you implemented, and the quantifiable results achieved.

• Focus on Impact: Emphasize how your quality strategies directly supported GTM objectives, such as ensuring product availability, reducing time-to-market, or mitigating commercial risks.

• Highlight Leadership & Collaboration: Showcase instances where you led teams, influenced stakeholders, and collaborated effectively across departments and geographies.

• Be Prepared for Deep Dives: Anticipate detailed questions about your processes, decision-making, and the technical aspects of your work.

• Visual Aids: Use clear, concise slides that highlight key data, process flows, and outcomes. Avoid overly technical jargon unless necessary and explain it clearly.

📝 Enhancement Note: Operations professionals should emphasize their ability to translate strategic quality requirements into actionable operational plans and demonstrate how their contributions directly impact the GTM success of pharmaceutical products. Highlighting analytical skills, process improvement methodologies, and cross-functional leadership will be crucial.

📌 Application Steps

To apply for this Director, Quality Product Strategy (Devices) position:

• Submit Your Application Online: Visit https://jobs.msd.com/gb/en and search for Requisition ID: R390606. Ensure your application is submitted by April 10, 2026, to meet the posting end date.

• Tailor Your Resume: Customize your resume to highlight your 12+ years of experience in quality oversight, technical operations, and supply chain strategy. Emphasize achievements related to product launches, regulatory compliance, QMS development, and cross-functional leadership, using keywords from the job description and AI-identified keywords.

• Prepare Your Portfolio: Curate 2-3 impactful case studies that demonstrate your strategic thinking, process improvement capabilities, and leadership in quality management within a pharmaceutical or regulated industry context. Focus on quantifying results and linking them to GTM objectives.

• Practice Your Interview Responses: Rehearse answers to common interview questions, particularly those focusing on strategy, leadership, problem-solving, and cross-functional collaboration, using the STAR method. Be ready to discuss your portfolio items in detail.

• Research MSD: Familiarize yourself with MSD's mission, values, product portfolio, and recent news. Understand their approach to quality and innovation to better align your responses and demonstrate cultural fit.

⚠️ Important Notice: This enhanced job description includes AI-generated insights and operations industry-standard assumptions. All details should be verified directly with the hiring organization before making application decisions.