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Associate Director, Vendor Compliance Management
BioNTech SEAssociate Director managing vendor compliance management at BioNTech. Leading quality assurance for vendors in the Pharmaceutical industry with a focus on regulatory compliance.
About the role
Key responsibilities & impact- Design and/or manage a strategy and proactive risk-based quality oversight program for vendors
- Manage the vendor qualification process and ensure the vendor qualification database is maintained
- Ensure vendor oversight after qualification through execution of quality assurance agreements, QA-QA calls, etc.
- Lead a team of QA personnel across multiple geographic locations
- Maintain strong relationships with internal and external stakeholders
- Ensure adherence to departmental procedures and that documentation produced under SOPs is inspection-ready
- Establish and maintain relevant KPIs
- Support inspection activities as requested
Requirements
What you’ll need- Degree in Life Sciences preferred
- Master’s degree desired; equivalent additional work experience will be considered
- Minimum of 10 years’ experience in quality assurance within a regulated clinical environment in the pharmaceutical industry
- Solid understanding of clinical development activities
- Experience with global regulations
- Extensive experience with Good Clinical Practice (GCP)
- Good Pharmacovigilance Practice is considered an advantage
- Ability to travel for stakeholder and leadership meetings as required
- Experience with due diligence, vendor qualification, and compliance oversight
- Strategic project development and project management skills
- Resource and budget planning experience
- Proficient with Microsoft Office tools
Benefits
Comp & perks- Health insurance
- Professional development opportunities
- Flexible working hours
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancevendor qualificationGood Clinical Practice (GCP)Good Pharmacovigilance Practiceclinical developmentcompliance oversightstrategic project developmentproject managementresource planningbudget planning
Soft Skills
leadershiprelationship managementcommunicationteam managementorganizational skillsstrategic thinkingproblem-solvingstakeholder engagementadaptabilityattention to detail