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A well-established growing CDMO located in eastern PA, is seeking a Director of Quality Assurance. The company is a formulation- focused service provider with a scientific staff of ~ 40 developers.
The successful candidate will be responsible for oversight of QA activities supporting GMP / GLP work including clinical trial material production and analytical /stability services. The incumbent will also lead/participate in interactions with external (clients) and with other internal functional groups/quality stake holders. The incumbent will be in charge of internal GMP audits, training and GMP compliance enforcements, reviewing batch records and releasing drug products, and any other responsibilities as assigned.
Salary is commensurate with experience and is competitive. Benefits include a matching 401K and full health insurance coverage.
Requirements
Qualifications:
An advanced degree in a related field a minimum of 7+ years of total industrial experiences in Quality Units in either a developmental setting or commercial manufacturing setting from a major pharmaceutical company or from a generic drug industry. Experience must include sterile products. Experience in a CRO setting is a plus. Besides the QA expertise, the candidate should ideally have some prior technical experiences in either drug product formulation area, or in analytical area (such as stability testing), or in GMP training/GMP enforcement area. The successful candidate will have excellent communication and organizational skills and be comfortable in a very fast paced environment.
This is a great opportunity to use your drug development skills with a company that recognizes and rewards top performers.
