Associate Director of GCP/GCLP Vendor Quality Management
We’re seeking a highly motivated and talented Associate Director of QA to lead the GxP Vendor Quality Management program. Working closely with Clinical Operations, Translational Medicine, Toxicology, and CMC Teams, this role will have primary responsibilities for ensuring proper vendor oversight for all GxP activities at its CROs, CMOs, Clinical Sites, and third-party laboratories and vendors. Reporting to the Head of Quality Assurance, this role will implement and maintain a phase-appropriate vendor quality management system that supports the companies quality and compliance efforts. This individual will perform both on-site and virtual vendor audits of GCP and GCLP organizations and will coordinate vendor qualification activities of GMP facilities by managing a team of audit consultants.
Responsibilities:
• Lead the Vendor Quality Management function to develop and implement an effective and phase appropriate vendor quality oversight program in accordance with domestic and international regulations, including 21 CFR, EudraLex Volume 4 and applicable annexes, USP/EP compendia, ICH and ISO standards and principles.
• Develop and implement vendor qualification and audit processes for external vendor oversight.
• Manage the Vendor qualification program for all GxP vendors.
• Perform virtual and on-site audits of GCP and GCLP vendors.
• Manage a team of audit consultants who will schedule and perform GMP vendor qualification audits.
• Write or oversee the writeup of qualification reports and corrective actions including risk management plans.
• Develop qualification plans via risk analysis and criticality of GxP vendors.
• Develop process to track audit observations and ensure implementation of corrective actions at vendor sites.
• Design and execute annual audit plans in collaboration with SMEs.
• Support/negotiate vendor Quality Agreements.
• Create and maintain an approved vendor list.
• Ensure personnel comply with the requirements of the vendor qualification program.
• Generate informative metrics and present at senior leadership meetings.
Qualifications:
• BS/MS in biology, chemistry, life sciences or related field.
• At least 10 years’ experience in the pharmaceutical or biotech industry with significant experience in GCP and GCLP Quality Assurance.
• Previous experience as lead auditor performing onsite and virtual GCP and GCLP vendor audits is required.
• ASQ-CQA certification preferred.
• Working knowledge of GMPs is preferred.
• Knowledge of domestic and international regulations, including 21 CFR, EudraLex Volume 4 and applicable annexes, USP/EP compendia, ICH and ISO standards and principles.
• Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities.
• Independently motivated, detail-oriented, and “can-do” attitude.
• Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
• Must have proficient computer skills and be experienced using MS office software (Word, Excel, PowerPoint, Project).
• Ability and willingness for approximately 30% travel – domestic and international, consistent with project needs.