The VP of Quality is the functional head of quality for the company, overseeing quality assurance and quality control, managing the total compliance function. The VP of Quality will be responsible for ensuring compliance with established company quality policies, practices, standard operating procedures (SOPs) and federal regulations.
Our biotech clients seek quality leaders who are career-driven, have strong management and mentoring skills and a depth of experience in managing complex quality systems. Our companies offer strong career growth potential and excellent benefits. We have many opportunities – all with top biotech companies seeking the best in quality assurance leadership.
typical roles and responsibilities for VP Quality
Design, implement and maintain (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 commercial partners.
Coordinate with regulatory agencies and other external auditors to build trust and confidence in company 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.
Requirements for VP of Quality
Bachelor’s Degree in Science or a related field; advanced degree strongly preferred
12+ years’ experience in the pharmaceutical or biotechnology industry in a quality or compliance
2+ years experience as a functional head of a quality department
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