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