Executive Director, CSRM Device and Product Quality

MSD • North Wales, PA

3d • Hybrid

About The Position

The Executive Director, CSRM Device and Product Quality provides strategic and operational leadership for a global Center of Excellence delivering medical and scientific expertise in device safety, health hazard oversight, and product quality medical risk assessment. Reporting to the Vice President, Clinical Safety and Risk Management (CSRM), this role sets clinical risk management strategy, governance, and compliant processes for medical support of devices and combination products across the full product lifecycle. The role is accountable for leading the strategy and implementation of timely medical risk assessment in support of quality issues across developmental and commercial products. The Executive Director leads cross‑functional collaboration across CSRM Therapeutic Area leadership, device development, commercial, manufacturing, and regulatory organizations to ensure patient safety, regulatory compliance, and successful execution of the Company’s product portfolio.

Requirements

• M.D. with 7–12 years of relevant experience in clinical safety, pharmacovigilance, or related safety disciplines, including 3–5 years of experience supporting manufacturing safety and/or drug device development.
• Demonstrated scientific expertise, strong medical judgment, and the ability to communicate risk and benefit effectively.
• Thorough familiarity with global regulatory agencies and regulatory expectations.
• Proven leadership capability, including building and leading high‑performing, cross‑disciplinary teams with integrity and accountability.
• Outstanding interpersonal, communication, and negotiation skills.
• Accountability
• Change Management
• Clinical Trial Oversight
• Communication
• Compliance Investigations
• Confidentiality
• Cross-Cultural Awareness
• Drug Safety Surveillance
• Leadership
• Mentoring Staff
• People Leadership
• Pharmacovigilance
• Post Marketing Surveillance
• Regulatory Communications
• Regulatory Reporting
• Results-Oriented
• Stakeholder Management
• Transformational Change

Nice To Haves

• Deep expertise in global regulatory requirements and emerging landscape for drug devices, combination products, and GMP compliance across development and lifecycle management.
• Comprehensive understanding of GPV and GMP requirements with a strong compliance mindset.

Responsibilities

• Device Safety Strategy and Governance Define and own the global safety strategy for interpretation of regulatory requirements related to medical safety contributions to drug devices and combination products across development and marketed products.
• Provide strategic oversight of device risk management activities through Clinical Safety and Risk Management (CSRM) device experts in collaboration with Risk Management Safety Teams (RMSTs).
• Lead collaboration with our Manufacturing Division and Global Regulatory Affairs and Clinical Safety (GRACS) regulatory device organizations to deliver integrated and consistent approaches to product safety and quality oversight.
• Partner with CSRM Therapeutic Area leaders to ensure aligned safety input into Product Development Teams (PDTs), Device Development sub‑teams, Global Regulatory Teams (GRTs), and Risk management and Safety Teams (RMSTs).
• Health Hazard and Product Quality Medical Assessment Define strategy and standards for medical assessment of product quality observations and deviations impacting developmental and marketed drugs and vaccines.
• Provide senior medical subject matter expertise during investigations of product quality complaints and GMP non‑compliance events, including participation in investigative review, fact-finding, and recall decision meetings.
• Lead CSRM and Manufacturing collaborations to develop, maintain, and continuously improve processes that ensure patient safety, product quality, and regulatory compliance.
• Represent CSRM leadership on shared governance committees with Manufacturing and other enterprise stakeholders.
• People, Leadership, and Enterprise Impact Lead and develop a global Center of Excellence comprised of approximately 8–10 physicians and scientists with expertise in device and product quality safety.
• Foster a high‑performing, collaborative, and scientifically rigorous team culture aligned with company values and ethical standards.
• Provide strategic input and oversight for departmental budget and headcount, approving direct report expenses and ensuring compliance with spending guidelines.
• Serve as an enterprise leader influencing cross‑functional decision‑making related to product safety, quality, and compliance.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree