|Title:||VP, Head of Quality Assurance and Quality Control|
VP, Head of Quality Assurance and Quality Control
The Vice President, Head of Quality Assurance and Quality Control manages the total compliance function for Aevi. This includes ensuring compliance with established company quality policies, practices, standard operating procedures (SOPs) and federal regulations.
- This role is responsible for designing, implementing and maintaining (GxP) QA and QC programs, and the compliance infrastructure. This includes the SOP system, training programs, and performing internal and external audits.
- Lead and manage inspections by FDA, other regulatory agencies and company’s commercial partners.
- Coordinate with regulatory agencies and other external auditors to build trust and confidence in Aevi’s quality systems.
- Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements.
- Work with the company’s external suppliers including Clinical Research Organizations (CROs) and contract labs to ensure consistent quality and compliance.
- Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GXP regulations.
- Oversee compliance (GMP and GCP) auditing program to fulfill regulatory requirements.
- Develop, manage and monitor adherence to the overall Quality and Compliance budget.
- Develop, analyze and report business metrics and highlights.
- Bachelor’s Degree in Science or a related field (Advanced degree preferred) with 15 years of experience in the pharmaceutical or biotechnology industry in a quality or compliance, with at least 2 years as a functional head
- Strong GxP knowledge in the pharmaceutical industry
- Hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)
- Proven record of developing and maintaining successful working relationships with regulatory agencies