Director, Quality Product Strategy (Devices)

📍 Job Overview

Job Title: Director, Quality Product Strategy (Devices)

Company: MSD

Location: Rahway, New Jersey, United States

Job Type: FULL_TIME

Category: Quality Operations / Product Strategy

Date Posted: 2026-06-12

Experience Level: 10+ Years

Remote Status: Hybrid

🚀 Role Summary

• Leads the development and execution of end-to-end pharmaceutical product quality strategy within the manufacturing and testing network, focusing on both pipeline launches and uninterrupted commercial supply.

• Drives the creation and implementation of robust quality strategies, including product analytical strategies, risk mitigation, and supply chain robustness for assigned product franchises.

• Acts as a key quality representative on Value Chain Management Teams (VCMT) and Development and Commercialization Teams (DCT), ensuring alignment and driving strategic initiatives.

• Oversees franchise-level documentation, including Comparability Plans, CPV plans, and regulatory submission support, ensuring compliance and strategic alignment.

• Champions inspection readiness and supports site-specific and network-wide quality initiatives to maintain high standards across global operations.

📝 Enhancement Note: The role title "Director, Quality Product Strategy (Devices)" indicates a focus on both pharmaceutical product quality strategy and potentially the quality aspects of medical devices, although the description primarily details pharmaceutical operations. The emphasis on "end-to-end pharmaceutical product strategy in our manufacturing and testing network" and "small molecule products" suggests a strong pharmaceutical manufacturing context. The "Devices" in the title might imply a broader scope that includes quality considerations for drug delivery devices or related hardware, which would require a deep understanding of both pharma GXP and potentially medical device quality regulations (e.g., ISO 13485). Given the primary responsibilities detailed, the focus appears to be on the pharmaceutical product lifecycle within manufacturing operations.

📈 Primary Responsibilities

• Lead the development and oversight of product quality strategic elements for pharmaceutical franchises, defining short and long-term goals in alignment with cross-functional teams (DCT/VCMT/Councils).

• Ensure progress, prioritization, and appropriate escalation of quality-related strategic goals, including efficiency and compliance, through periodic reviews and dashboards across global manufacturing and testing sites.

• Review and approve critical franchise-level documentation such as Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Reviews, Control Strategies, and regulatory filing submissions.

• Lead or coordinate Quality Working Group meetings 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 Quality Management System (QMS) Chapter leads to define, refine, and standardize quality requirements, identifying and addressing QMS gaps for consistent regulation interpretation and driving continuous improvement in QMS documentation.

• Evaluate Annual Product Reviews for supply chain trends, escalate risks, and support the development of Analytical Siting decisions, actively monitoring and mitigating franchise Quality risks.

• Participate in regulatory inspections, champion Permanent Inspection Readiness (PIR) for product programs, and lead/coordinate responses to franchise-level regulatory observations.

• Support strategic network changes, including expansion and supply chain robustness initiatives, for the inline product portfolio.

📝 Enhancement Note: The responsibilities clearly delineate a strategic, leadership-oriented role focused on the quality aspects of pharmaceutical product lifecycle management within a global manufacturing and testing network. The emphasis on documentation review, cross-functional leadership (VCMT, DCT), and strategic planning indicates a need for strong process understanding, regulatory compliance knowledge, and stakeholder management skills. The mention of "small molecule products" suggests a specialization within the pharmaceutical domain.

🎓 Skills & Qualifications

Education: Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics.

Experience: Minimum of twelve (12) years of experience in quality oversight roles, including technical elements or technical operations roles. Minimum of 2 years direct experience with supply chain strategy or technical elements (e.g., change controls, investigations, process documentation like protocols, CPV). Experience preferably with small molecule products.

Required Skills:

• Demonstrated success leading multi-functional teams to drive continuous improvement and execute strategic actions across a network of groups, sites, and functions.

• Strong external-facing communication skills, both written and verbal.

• Entrepreneurship/Innovation: Ability to meet patient, customer, and organizational needs by confronting difficult issues, offering creative alternatives, and taking action.

• Decision Making/Influence: Proficient in identifying and understanding problems, gathering and analyzing information, establishing decision criteria, identifying alternatives, and making timely decisions using effective involvement and persuasion strategies.

• Growth/Development/Change: Ability to utilize new knowledge and skills on the job, learn through application, and modify behavior to improve impact and adaptability during significant work changes.

• Networking/Inclusion: Skill in building partnerships and developing/leveraging relationships within and across work groups to achieve results, working effectively across cultures and interpersonal styles.

• Execution Excellence/Ownership/Inspiration: Proactive approach to setting high performance standards, completing assignments, communicating effectively and clearly, and listening actively.

• Analytical Thinking.

• Collaboration.

• Communication.

• Cross-Functional Work.

• Global Supply Chain Strategy.

• Inspection Readiness.

• Medical Devices (as per title).

• Product Quality.

• Quality Assurance (QA).

• Quality Mindset. Preferred Skills:

• Experience with small molecule products (stated as preferred but also a requirement for 2 years experience).

• Proficiency in Enterprise Leadership Skills.

📝 Enhancement Note: The required skills section is exceptionally detailed, outlining specific "Enterprise Leadership Skills" which are crucial for a Director-level role. These behavioral competencies are as important as the technical ones for success in managing complex quality strategies and influencing stakeholders across a global organization. Applicants should prepare to provide specific examples demonstrating these skills. The mention of "Medical Devices" in the required skills, coupled with the job title, suggests that while the core focus might be pharmaceuticals, experience with device quality considerations is a significant plus.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Product Quality Strategy Documentation: Showcase examples of strategic plans developed for product franchises, including objectives, timelines, and key performance indicators (KPIs) related to quality and compliance.

• Cross-Functional Leadership Case Studies: Present documented instances of leading Value Chain Management Teams (VCMT) or Development and Commercialization Teams (DCT), highlighting successful navigation of complex quality challenges and cross-functional alignment.

• Process Improvement Initiatives: Include detailed case studies of initiatives that improved quality processes, such as change control, investigation management, or Annual Product Review (APR) efficiency, demonstrating quantifiable improvements.

• Regulatory Compliance & Inspection Readiness: Provide examples of documentation reviewed or approved (e.g., Comparability Plans, CPV plans, regulatory observation responses) and evidence of contributions to successful inspection readiness programs.

Process Documentation:

• Workflow Design and Optimization: Demonstrate experience in designing, refining, and standardizing quality requirements, including contributions to Quality Management System (QMS) documentation and ensuring consistent interpretation of regulations.

• Implementation and Automation Methods: Showcase how strategic quality goals were implemented across a network of sites, including strategies for driving efficiency and compliance.

• Measurement and Performance Analysis: Provide examples of tracking and analyzing franchise-level quality metrics (e.g., change control, complaint data) and using this data to evaluate trends, mitigate risks, and inform strategic decisions.

📝 Enhancement Note: For a Director-level role focused on strategy, the portfolio should emphasize strategic thinking, leadership, and impact. Case studies demonstrating the ability to influence cross-functional teams, manage complex documentation, and drive systemic improvements in quality processes are paramount. Quantifiable results and clear articulation of ROI for quality initiatives will be highly valued.

💵 Compensation & Benefits

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

Benefits:

• Comprehensive medical, dental, and vision healthcare benefits for employees and their families.

• Retirement savings plan, including a 401(k).

• Paid time off, including holidays, vacation, compassionate days, and sick days.

• Annual bonus program.

• Long-term incentive program (if applicable).

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

Working Hours: 40 hours per week, typically within a 1st shift (Day) schedule.

📝 Enhancement Note: The provided salary range is substantial, reflecting a senior leadership position. The benefits package is comprehensive, typical for a large pharmaceutical organization. The "Flexible Work Arrangements: Hybrid" and "Travel Requirements: 10%" indicate a structured hybrid model where occasional travel is expected, common for senior roles coordinating across global sites. The salary estimate is based on the provided data and aligns with Director-level compensation for Quality Strategy roles in the pharmaceutical industry in the New Jersey region, considering the company's size and the role's strategic importance.

🎯 Team & Company Context

🏢 Company Culture

Industry: Pharmaceutical and Healthcare. MSD (Merck & Co., Inc.) is a global leader in discovering, developing, manufacturing, and marketing a wide range of innovative prescription medicines, vaccines, biologic therapies, and animal health products. The company is deeply invested in research and development to address unmet medical needs worldwide.

Company Size: Large enterprise (implied by the global reach, extensive product portfolio, and hiring process details).

Founded: 1891 (as Merck & Co. in the US). This long history denotes a stable, established organization with deep expertise and a significant market presence, implying a culture that values experience, rigorous processes, and long-term strategic vision.

Team Structure:

• This role likely sits within a global Quality organization, potentially reporting to a VP or Senior Director of Quality Product Strategy or Manufacturing Operations.

• The Director will be a key member of cross-functional teams like the Value Chain Management Team (VCMT) and Development and Commercialization Team (DCT), collaborating closely with representatives from R&D, Manufacturing, Regulatory Affairs, Supply Chain, and Commercial functions.

• The team structure emphasizes matrixed leadership and collaboration, requiring strong influence and communication skills to drive alignment and execution across diverse organizational units and geographical locations. Methodology:

• Data-Driven Quality Assurance: Emphasis on leveraging data from Annual Product Reviews, change controls, complaints, and other quality metrics to inform strategic decisions, identify trends, and mitigate risks.

• Process Optimization & Standardization: A focus on refining and standardizing Quality Management System (QMS) requirements to ensure consistent interpretation of global regulations and drive continuous improvement.

• Strategic Planning & Execution: A structured approach to developing and executing long-term quality strategies for product franchises, ensuring alignment with broader business objectives and pipeline milestones.

• Risk Management: Proactive identification, assessment, and mitigation of quality-related risks across the product lifecycle and supply chain.

Company Website: https://www.msd.com/

📝 Enhancement Note: MSD's significant presence in the pharmaceutical industry suggests a culture that prioritizes scientific rigor, regulatory compliance, and innovation. For operations professionals, this means a structured environment with established processes, but also a drive for continuous improvement and strategic impact. Understanding MSD's commitment to R&D and global health initiatives will be crucial for demonstrating cultural fit.

📈 Career & Growth Analysis

Operations Career Level: Director. This role signifies a senior leadership position responsible for strategic direction and oversight of quality product strategy for specific pharmaceutical franchises. It requires significant experience, a strong understanding of pharmaceutical manufacturing and quality systems, and the ability to lead and influence at a global level.

Reporting Structure: The Director will likely report to a Vice President or Senior Director within the Quality or Manufacturing organization. They will manage direct reports or lead matrixed cross-functional teams, serving as a key quality representative to senior leadership forums like VCMT and DCT.

Operations Impact: This role has a direct and significant impact on MSD's ability to successfully launch new products, ensure the uninterrupted supply of existing critical medicines, maintain regulatory compliance, and manage global supply chain risks. Strategic quality decisions made by this Director directly influence product availability, patient safety, and the company's reputation and financial performance.

Growth Opportunities:

• Leadership Progression: Potential to advance to Senior Director or Vice President roles within Quality, Manufacturing, or related strategic functions, overseeing larger portfolios or broader operational areas.

• Specialization & Expertise: Deepen expertise in specific therapeutic areas, advanced quality methodologies, or global regulatory landscapes. Opportunity to become a recognized subject matter expert within the organization.

• Cross-Functional Mobility: Potential to move into broader strategic roles within R&D, Supply Chain, or Commercial Operations, leveraging a deep understanding of the product lifecycle and quality requirements.

• Global Project Leadership: Lead major global initiatives related to network expansion, digital transformation in quality, or significant QMS overhauls.

📝 Enhancement Note: For operations professionals, this Director role represents a significant career milestone. The emphasis is on strategic leadership and cross-functional influence rather than day-to-day operational management. Growth opportunities are geared towards senior executive leadership within a large, complex pharmaceutical organization.

🌐 Work Environment

Office Type: Hybrid. The role is based in Rahway, New Jersey, with a hybrid work arrangement, suggesting a blend of on-site work for collaboration and strategic meetings, and remote work for focused tasks.

Office Location(s): The primary listed location is Rahway, New Jersey, a major hub for MSD's operations. Other potential locations mentioned (Saitama, Japan; Durham, NC; West Point, PA; Elkhorn, NE) indicate a global presence and the need for cross-site collaboration, but the Director role is primarily based in Rahway.

Workspace Context:

• Collaborative Environment: The hybrid model and the nature of the role necessitate significant collaboration with global teams, requiring strong virtual communication and collaboration tool proficiency.

• Operations Tools & Technology: Access to advanced data analytics platforms, QMS software, project management tools, and internal communication systems will be essential for managing quality strategy and documentation.

• Team Interaction: Opportunities for direct interaction with senior leadership, cross-functional peers, and potentially site-based quality teams, both virtually and during occasional travel.

Work Schedule: The standard 40-hour work week with a 1st shift (Day) schedule is typical for a Director role. However, given the global nature of the responsibilities and potential for urgent quality or regulatory issues, flexibility may be required, especially when collaborating with teams in different time zones.

📝 Enhancement Note: The hybrid nature of the role requires strong self-management and organizational skills. While based in Rahway, the functional scope is global, demanding adaptability to different time zones and cultural nuances when collaborating with international teams.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: Likely a recruiter or HR screening to assess basic qualifications, experience, and alignment with company values.

• Hiring Manager Interview: In-depth discussion with the hiring manager focusing on strategic leadership, operational experience, and specific examples of managing quality product strategy.

• Cross-Functional Panel Interviews: Interviews with key stakeholders from R&D, Manufacturing, Regulatory Affairs, and other relevant departments to assess collaboration, influence, and strategic alignment.

• Executive/Senior Leader Interview: A final interview with a senior executive (e.g., VP of Quality, Head of Manufacturing) to evaluate overall fit, strategic vision, and leadership potential.

• Presentation/Case Study: Candidates may be asked to prepare and present a case study or strategic proposal related to quality product strategy, demonstrating their analytical skills, strategic thinking, and communication abilities.

Portfolio Review Tips:

• Strategic Impact: Focus on case studies that demonstrate your ability to shape and execute product quality strategy, leading to tangible business outcomes (e.g., successful product launches, improved compliance, reduced supply chain risks, enhanced efficiency).

• Leadership & Influence: Highlight examples where you successfully led cross-functional teams, influenced senior stakeholders, and navigated complex organizational dynamics to achieve quality objectives.

• Process & Systemic Improvement: Showcase your understanding of QMS, regulatory requirements, and your ability to drive standardization and continuous improvement in quality processes and documentation.

• Quantifiable Results: Wherever possible, quantify the impact of your contributions using metrics related to cost savings, efficiency gains, risk reduction, or compliance improvements.

• Tailoring: Align your portfolio examples with MSD's industry, products (especially small molecules), and stated values.

Challenge Preparation:

• Strategic Case Study: Be prepared to analyze a hypothetical quality product strategy challenge, outline a recommended approach, identify key risks, and propose metrics for success.

• Cross-Functional Collaboration Scenario: Practice articulating how you would gain alignment and drive action across diverse teams with potentially competing priorities.

• Regulatory Compliance Scenarios: Review common regulatory challenges in pharmaceutical manufacturing and be ready to discuss how you would address them from a strategic quality perspective.

📝 Enhancement Note: The interview process for a Director-level role at a company like MSD is typically rigorous and multi-stage, designed to thoroughly assess strategic leadership, technical expertise, and cultural fit. A well-curated portfolio that clearly articulates impact and strategic thinking is essential.

🛠 Tools & Technology Stack

Primary Tools:

• Quality Management Systems (QMS): Experience with enterprise QMS platforms (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, Oracle) for integrated supply chain and manufacturing data.

• Project Management Software: Proficiency in tools like Microsoft Project, Asana, or Jira for managing strategic initiatives and cross-functional projects.

• Collaboration & Communication Platforms: Microsoft Teams, Slack, Zoom, SharePoint for daily communication, virtual meetings, and document sharing.

Analytics & Reporting:

• Data Analytics Tools: Experience with tools like Tableau, Power BI, or advanced Excel for data analysis, trend identification, and reporting on quality metrics.

• Statistical Software: Familiarity with statistical analysis software (e.g., JMP, Minitab) for process validation, comparability studies, and risk assessments.

• Business Intelligence (BI) Platforms: For creating dashboards and visualizing key quality performance indicators (KPIs) for senior leadership.

CRM & Automation:

• CRM Systems (Indirect Relevance): While not a direct CRM role, understanding how product quality strategy impacts commercialization and customer experience (as managed by CRM) is beneficial.

• Workflow Automation: Experience with tools or methodologies that automate QMS processes or data reporting to enhance efficiency.

• Document Management Systems: Robust systems for managing and versioning critical quality documentation.

📝 Enhancement Note: Given the strategic nature of the role, proficiency in data analysis and visualization tools is crucial for developing and presenting quality strategies. Familiarity with enterprise-level QMS and ERP systems is expected for overseeing quality operations within a large manufacturing network.

👥 Team Culture & Values

Operations Values:

• Patient Centricity: A foundational value in the pharmaceutical industry, ensuring all quality decisions ultimately serve patient safety and product efficacy.

• Integrity & Ethics: Upholding the highest standards of ethical conduct and regulatory compliance in all operations.

• Excellence & Continuous Improvement: A commitment to rigorous standards, data-driven decision-making, and ongoing enhancement of processes and systems.

• Collaboration & Inclusion: Fostering a diverse and inclusive environment where different perspectives are valued, and cross-functional teams work together effectively.

• Innovation: Encouraging creative problem-solving and the adoption of new technologies and methodologies to advance quality and operational efficiency.

Collaboration Style:

• Matrixed Leadership: The role requires influencing and collaborating with peers and stakeholders across various departments and global sites, often without direct reporting authority.

• Data-Informed Dialogue: Discussions and decision-making are expected to be grounded in data and scientific evidence.

• Proactive Communication: Open and transparent communication is key to managing risks, aligning strategies, and ensuring smooth execution across the global network.

• Respectful Challenge: A culture that encourages constructive debate and challenges assumptions to arrive at the best possible quality strategies and solutions.

📝 Enhancement Note: MSD's emphasis on "innovation through diversity" and "respectfully challenging the thinking" suggests a dynamic culture where strategic contributions are valued, and employees are empowered to drive change. Understanding these values will be critical for demonstrating cultural fit.

⚡ Challenges & Growth Opportunities

Challenges:

• Global Complexity: Navigating diverse regulatory landscapes, cultural differences, and operational variations across multiple international manufacturing and testing sites.

• Balancing Strategy and Execution: Ensuring that strategic quality plans are effectively translated into actionable initiatives and implemented consistently across the network.

• Stakeholder Alignment: Gaining and maintaining alignment among diverse stakeholders with potentially competing priorities (e.g., R&D timelines vs. Manufacturing capacity vs. Regulatory requirements).

• Rapidly Evolving Regulatory Environment: Keeping pace with changes in pharmaceutical quality regulations and adapting strategies accordingly.

• Data Integration and Analysis: Consolidating and analyzing vast amounts of quality data from disparate systems to derive meaningful insights and support strategic decisions.

Learning & Development Opportunities:

• Advanced Quality Methodologies: Opportunities to gain deeper expertise in areas like Quality by Design (QbD), process analytical technology (PAT), or advanced statistical process control.

• Global Regulatory Affairs: Exposure to and development in understanding complex global regulatory submission processes and compliance requirements.

• Executive Leadership Development: Participation in leadership training programs focused on strategic planning, financial acumen, and executive communication.

• Industry Conferences & Certifications: Encouragement to attend relevant industry conferences (e.g., DIA, ISPE) and pursue professional certifications in quality management or regulatory affairs.

• Mentorship Programs: Access to mentorship from senior leaders within MSD's quality and manufacturing organizations.

📝 Enhancement Note: This role presents significant challenges inherent in managing quality strategy for a global pharmaceutical enterprise. The growth opportunities are substantial, offering pathways for deep specialization or broader executive leadership within the company.

💡 Interview Preparation

Strategy Questions:

• "Describe a time you developed and implemented a long-term quality product strategy for a pharmaceutical franchise. What were the key components, challenges, and outcomes?"

• "How do you approach aligning strategic quality goals with diverse cross-functional teams, such as R&D, Manufacturing, and Regulatory Affairs, especially when priorities differ?"

• "Walk me through your process for identifying, assessing, and mitigating quality risks within a global supply chain. Provide a specific example."

• "How would you ensure inspection readiness for a product program, and what is your experience in responding to regulatory observations?" Company & Culture Questions:

• "What do you know about MSD's commitment to innovation and patient-centricity, and how would your role contribute to these values?"

• "Describe your experience working in a hybrid environment and collaborating with global teams across different time zones and cultures."

• "How do you approach fostering a culture of continuous improvement and quality ownership within a large organization?"

• "What are your thoughts on the importance of Quality Management System (QMS) standardization and continuous refinement?" Portfolio Presentation Strategy:

• Structure Your Narrative: For each case study, clearly define the context, your role, the challenge, the strategic approach you took, the actions you implemented, and the quantifiable results achieved.

• Focus on Strategic Impact: Emphasize how your contributions directly supported business objectives, such as successful product launches, supply chain robustness, or compliance improvements.

• Demonstrate Leadership & Influence: Clearly articulate how you led teams, influenced stakeholders, and navigated organizational complexities to achieve desired outcomes.

• Visualize Data: Use charts and graphs to present metrics and trends effectively, making your impact easy to understand and digest.

• Tailor to MSD: Connect your experiences and examples to MSD's specific industry, product types (small molecules), and likely operational challenges.

📝 Enhancement Note: Preparing specific, STAR-method (Situation, Task, Action, Result) examples for behavioral questions, especially those related to the "Enterprise Leadership Skills" listed, will be critical. Candidates should also be ready to articulate their strategic vision for quality product strategy within the pharmaceutical industry.

📌 Application Steps

To apply for this operations position:

• Submit your application through the provided Workday link or the MSD careers portal.

• Curate Your Operations Portfolio: Select 2-3 key projects or initiatives that best showcase your strategic leadership, cross-functional influence, and impact on product quality and supply chain robustness. Quantify results with relevant metrics.

• Optimize Your Resume: Tailor your resume to highlight experience in pharmaceutical quality strategy, global supply chain management, regulatory compliance, and leadership of multi-functional teams. Integrate keywords from the job description naturally.

• Prepare Your Presentation: If a case study or presentation is required, structure it around a significant achievement that demonstrates your strategic thinking, problem-solving abilities, and leadership acumen. Practice delivering it concisely and impactfully.

• Research MSD: thoroughly research MSD's current pipeline, therapeutic areas, recent news, and commitment to quality and innovation. Understand their approach to R&D and manufacturing to articulate how your experience aligns with their organizational goals.

⚠️ 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.