Executive Director, CSRM Device and Product Quality

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.

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.

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 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.

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

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:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$310,900.00 - $489,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

Employee Status:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
03/2/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R385953