Director, Vendor Compliance Management
Job Responsibilities
- Design and/or manage a strategy and proactive risk based quality oversight for vendors to ensure continuous inspection readiness and compliance with regulatory requirements
- Manage vendor qualification process and ensure maintenance of the vendor qualification database
- Ensure vendor oversight once qualified via execution of quality assurance agreements, QA-QA calls, etc.
- Lead team of QA personnel located in different geographical locations
- Maintain strong relationships with internal and external stakeholders
- Ensure adherence to departmental procedures and ensure documentation produced per execution of SOPs is inspection ready
- Establish and maintain relevant KPIs
- Support inspection activities upon request
Minimum Qualification:
- Academic degree in Life Science preferred
- Masters degree desired, although additional work experience would be considered instead
- Experienced people leader
- At least 10 years experience in quality assurance within a regulated clinical environment in the Pharmaceutical industry with a good understanding of clinical development activities
- Experience with global regulations, with robust experience in Good Clinical Practice. Good Pharmacovigilance
- Practice is considered an advantage
- Ability to travel for stakeholder and leadership meetings when necessary
- Experience with due diligence, vendor qualification and compliance oversight
- Demonstrated functional knowledge
- Strategic project development and project management
- Resource and budget planning
- Proficient and productive in Microsoft Office tools