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 crossfunctional collaboration across CSRM Therapeutic Area leadership device development commercial manufacturing and regulatory organizations to ensure patient safety regulatory compliance and successful execution of the Companys 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 subteams 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 noncompliance events including participation in investigative review factfinding 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 810 physicians and scientists with expertise in device and product quality safety.

• Foster a highperforming 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 crossfunctional decisionmaking related to product safety quality and compliance.

Education:

M.D. with 712 years of relevant experience in clinical safety pharmacovigilance or related safety disciplines including 35 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 highperforming crossdisciplinary 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:

Preferred Skills:

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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 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

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 employees 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 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

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