We are currently searching for a VP Quality – Pharmaceuticals to join an industry leading nuclear medicine company. Reporting directly to the CEO, the VP Quality – Pharmaceuticals will lead, optimize and execute quality activities for new product development and maintenance of current products. The VP Quality – Pharmaceuticals will lead quality affairs and ensure accountability for life cycle quality oversight for all products manufactured.
Requirements of the VP Quality – Pharmaceuticals:
Bachelor’s degree in related life science or business discipline, advanced degree preferred.
Minimum 15 years experience in the pharmaceutical industry increasing quality initiatives, interfacing with regulatory bodies including the FDA and Nuclear Regulatory Commission.
10+ years experience in a management role, developing teams, leading people, facilitating cooperation and team work.
Demonstrated experience overseeing regulatory agency inspections, acting as a liaison for all levels of regulatory agency inspections and ensuring compliance with RA procedures and policies.
Extensive experience operating in a radiopharmaceutical and pharmaceutical cGMP manufacturing environment as well as experience in Clinical Quality Assurance activities.
Familiarity with 21 CFR 211, 21 CFR 212 manufacturing and support of Clinical Trial Material manufacture and release.
Strong understanding of quality improvement initiatives including experience in audits.
Lean Six Sigma certification strongly preferred.
Responsibilities of the VP Quality – Pharmaceuticals:
Ensure compliance of all GxP quality systems for drugs and devices manufactured. Oversee quality initiatives and quality improvements.
Responsible for the performance of the QC and QA departments including measuring KPIs, compliance, customer satisfaction, labeling, timely testing and release, managing relationships with regulators, talent management, budget and communications related to quality.
Manage company’s QMS and documentation, review and approval of GxP procedures and records including training, supporting computer system validation documentation, management of employee training records, etc.
Handle trend analysis of inspection and audit observations and associated communication, ensure compliance metrics are in alignment with product life cycle and new product development.
Act as quality system resource and collaborate cross functionally with PMO, R&D, supply chain, regulatory affairs and commercial teams. Make quality decisions for new project teams and life cycle product teams including design, failure mode effect analysis and risk-based decision making.
Manage and improve auditing program, execute audits as related to GxPs.
Occupational Category: 19-1029 Biological Scientists, All Other
Application Instructions: Please apply using the form or send your resume to Debbie Winkelbauer.