Overview
Job Description
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.
The Executive Director reports 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.
Key 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 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 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.
Education
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.
Required Experience And Skills
- 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.
Preferred Experience And Skills
- 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.
Required Skills
Clinical Research, Clinical Safety, Communication, Drug Development, Drug Safety Surveillance, Leadership, Medical Device Evaluation, Medical Device Regulations, Medical Safety, People Leadership, People Management, Pharmaceutical Industry, Pharmacovigilance, Product Quality, Product Risk, Risk Management, Stakeholder Management, Team Management
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
EEO and Compliance
US And Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement.
Work Model and Compensation
U.S. Hybrid Work Model applies with details outlined in the posting. Salary range: $310,900.00 - $489,400.00. Eligible for annual bonus and long‑term incentive where applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days.
Application information: You can apply at (or via the Workday Jobs Hub if you are a current employee). The posting end date is 03/2/2026.
San Francisco Residents Only: Fair Chance Ordinance compliance. Los Angeles Residents Only: Fair Chance Initiative for Hiring Ordinance compliance.
Requisition ID: R
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