VP, Commercial QA - Novel Oncology Immunotherapies
Proclinical is currently recruiting for a Vice President of Commercial Quality Assurance with a leading biopharmaceutical company located in Philadelphia, PA. As the Commercial Quality Assurance VP, you will be responsible for leading commercial QA professionals to ensure GXP compliance in accordance with country regulations and guidelines, as well as the company's policies and procedures.
- Provide strategic direction for, and oversight of, all commercial QA programs.
- Build a commercial QA organization
- Establish the necessary SOPs and train to the SOPs
- Provide solutions-oriented and strategic advice for all commercial QA-related matters.
- Implement a commercial QA structure to support the company's global operations through following regulatory guidelines with an understanding of application to cell therapy
- Set the pace and standards of QA activities, while modeling behaviors and leadership aligned with the company's values.
- Support the planning and start-up of commercial operations, while ensuring that a QA framework is in-place for commercial launch.
- Drive corporate and department objectives to completion through strong collaboration with colleagues, other internal functions, and vendors.
- Ensure that the company and its contractors are prepared for state, regional, or country authority inspections. Coordinate all authority inspections by ensuring sufficient resources are in-place to respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
- Oversight of commercial providers of raw materials as well as CDMO partners
- Cultivate a culture of quality and shared accountability throughout the organization to help ensure compliance with applicable regulations, guidelines, and corporate standards, policies and procedures.
Skills and Requirements:
- 15+ years' experience in the Pharmaceutical/Biotechnology industry, with extensive leadership experience in commercial QA roles.
- Cell therapy experience strongly preferred
- Experienced overseeing commercial US and EU manufacturers.
- Expert knowledge of Health Authority expectations and industry practices in the US and Europe.
- Expert knowledge of FDA and ICH GXP regulations and guidelines.
- Having the credibility and reputation to attract and retain top talent and have a history of creating high-performing teams.
- Effective negotiation, communication, listening and writing skills, including those suitable for interaction with internal and external executive leadership, and Health Authorities.
- Exceptional ability to develop open and candid, collaborative working relationships with diverse stakeholders.
- Bachelor's degree in a scientific discipline, Advanced degree preferred
- Ability to travel, including international travel.
If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.