QA Validation Manager
A CDMO focusing on Cell and Gene Therapy is looking to make a key hire for their Quality and Validation team. They were the first CDMO worldwide to manufacture a commercial cell therapy product, and are making plans to go commercial within the next year. They are the pioneer within the emerging CGT industry as they have both region-specific regulatory expertise as well as the ability to tap into all of the top world markets. They are looking for a candidate who is interested in not only making a difference as a part of their quality team, but someone interested in being a part of business decisions that impact both your site and beyond!
- Document management: review and approval of validation protocols, reports, investigation reports, assignment of CAPA's, SOP development and revisions.
- Establishes Quality Validation KPI Reporting and Continuous Improvement metrics.
- Oversees and manages the activities of the validation team; provides leadership and direction to ensure that organizational and departmental goals are met.
- Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc.
- Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced.
- 5-8 years' relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments
- 2+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred.
- Knowledge of FDA and EMEA regulation and a working knowledge of root cause analysis.
- Experience in authoring, reviewing, and /or approving GMP documents
If you think that you are a good fit, please don't hesitate to apply!