Senior Director, Stability Operations – Device Program Management

MSD

Senior Director leading Merck’s pharmaceutical stability operations and drug-device program management. Integrating CMC, regulatory, quality, and technical deliverables across development portfolios.

Posted 8/10/2026full-timeRahway • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading stability operations and device program management within the pharmaceutical industry, integrating scientific, technical, and regulatory considerations into strategic program execution. Proven ability to build and mentor high-performing teams while ensuring compliance with GxP expectations and regulatory commitments.

Highest-signal resume keywords

Ph.D. In Chemistry, Pharmaceutical Sciences, Engineering, Biology, Or BiochemistryExtensive Experience In Pharmaceutical DevelopmentStrong Working Knowledge Of GxP ExpectationsExperience Leading Complex ProgramsExcellent Verbal And Written Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Stability OperationsAnalytical DevelopmentCMC Program ManagementRegulatory SubmissionsTechnical WritingChange ControlPortfolio ManagementRisk ManagementData ReviewGovernance Processes

Soft Skills

LeadershipTeam DevelopmentCross-Functional CollaborationProblem SolvingStakeholder Communication

Industry Keywords

Inspection ReadinessProduct Quality PrinciplesRegulatory GuidanceContinuous ImprovementCombination Product ProgramsHealth Authority InteractionsQuality SystemsDigital CMCSample LogisticsMilestone Delivery

About the role

Key responsibilities & impact

Provide strategic, scientific, operational, and people leadership for stability operations and device program management across the development portfolio
Establish and maintain an integrated operating model for stability study planning, protocol execution, sample logistics, storage, testing coordination, data review, and reporting
Lead device program management for drug-device and combination product programs, including plans, governance, risk management, decision making, and milestone delivery
Partner with CMC, regulatory, clinical, quality, manufacturing, supply chain, device development, and external partners
Ensure practices are inspection ready, compliant with GxP expectations, aligned with quality systems, and consistent with regulatory commitments
Develop portfolio-level metrics, dashboards, and governance routines to monitor delivery, identify risks, drive continuous improvement, and support senior-stakeholder communication
Build, mentor, and develop an inclusive, high-performing team
Oversee technical writing and change control, including BLA authoring, global change controls, and technical documentation
Set documentation standards, manage portfolio priorities, and partner with the digital team to support digital CMC and modernize commercial filing strategy
Integrate stability and device deliverables with CMC plans, regulatory strategies, clinical timelines, supply needs, and quality expectations
Sponsor cross-functional problem solving and drive consistent execution across internal and external networks

Requirements

What you’ll need

Ph.D. degree in Chemistry, Pharmaceutical Sciences, Engineering, Biology, Biochemistry, or related scientific discipline with 10+ years of relevant experience; or MS degree with 13+ years; or BS degree with 16+ years
Ability to lead large, inclusive, cross-functional scientific or operational teams and attract, develop, and retain talent
Extensive experience in pharmaceutical development, stability operations, analytical development, CMC, quality, regulatory, or related technical disciplines
Strong working knowledge of stability requirements, GxP expectations, regulatory guidance, product quality principles, and inspection readiness practices
Experience leading complex programs, managing portfolio-level priorities, and influencing senior stakeholders across functions and geographies
Ability to integrate scientific, technical, operational, regulatory, and business considerations into program strategies and executable plans
Excellent verbal and written communication skills
Preferred: track record leading stability operations, analytical operations, device development, combination product programs, or cross-functional CMC program management in a regulated pharmaceutical environment
Preferred: experience developing operating models, governance processes, metrics, and continuous improvement initiatives
Preferred: experience supporting regulatory submissions, health authority interactions, inspections, or product lifecycle activities
No visa sponsorship
Valid driving license: No

Benefits

Comp & perks

Annual bonus eligibility
Long-term incentive eligibility, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Flexible work arrangements: Hybrid
Relocation: Domestic