About the position
The Sr. Manager, Quality Compliance, CAR T is responsible for advancing a Compliance excellence mindset within Summit, NJ's Cell Therapy Organization to meet or exceed Global Health Authority requirements and expectations across the product lifecycle. The Sr. Manager plays a fundamental role in supporting and contributing to the execution of the quality compliance strategy for the Summit manufacturing site. The incumbent will work collaboratively with multiple departments across all functions and levels of the organization to provide strategic and tactical compliance support for the site. The incumbent will be responsible for leading site compliance activities involving health authorities, including evaluating significant quality events, leading fact-finding meetings for significant quality events, communicating status of significant quality events to the Senior Leadership team and authoring compliance reports to health agencies (Biological Product Deviation Reports (BPDRs) and Product Defect Notifications and Recalls). In addition, the incumbent will lead and coordinate critical compliance activities within Summit - including gap assessments, commitments, and responses to audit and inspection findings - and ensure any quality risks identified are proactively mitigated.
Responsibilities
- Leads the Summit West (S12) Compliance team in the identification of Significant Events that may require a Notification to Management (NTM).
- Leads / Hosts Fact Finding meetings on behalf of S12 manufacturing for any Significant Events.
- Issues Notifications to Management (NTM) for any Significant Events.
- Authors compliance reports to regulatory agencies, including Biological Product Deviation Reports to FDA (BPDRs), Product Defect Notifications to EMA or Drug Shortage Notifications.
- Communicates to site Senior Leadership Team regarding status of resolution.
- Partners with Quality, Medical Affairs and Patient Safety to ensure completion of Integrated Health Hazard Assessments (IHHAs).
- Ensures investigation of significant events are accurately communicated to the escalation team.
- Leads and coordinates critical compliance activities within S12.
- Participates in market recalls and mock recalls on behalf of S12.
- Collaborates with other relevant line functions to prepare and review regulatory submission documents.
- Monitors compliance related processes to examine the overall health of the quality system in S12.
- Ensure site's inspection readiness and prepares the site for regulatory inspections.
- Performs other Quality Compliance projects as required by management.
Requirements
- Bachelor's degree required.
- A minimum of 6 years of industry experience.
- At least 3 years of direct health authority interaction experience.
- A minimum of 3 years of experience in Quality deviation.
- Strong experience with continuous improvement within quality and regulations.
Nice-to-haves
- Advanced degree preferred.
- Experience in CAR T or Biologics is preferred.
- Professional certification in Regulatory Affairs or quality certifications is desired.
Benefits
- Competitive benefits, services and programs.
- Opportunities for career growth and development.
