Head of QA

About the Company

Well-established manufacturing company

Industry
Electrical/Electronic Manufacturing

Type
Privately Held

About the Role

The Company is seeking a Head of Quality with a strong background in clinical-scale GMP manufacturing and knowledge of FDA and ICH regulatory requirements. The successful candidate will be responsible for assisting in the development and implementation of cGMP manufacturing, working with the company's executives and senior managers to improve the culture of compliance, and establishing a quality-by-design (QBD) foundation. This role involves developing, implementing, and coordinating quality programs in compliance with federal and global regulatory requirements to support clinical manufacturing at CMO sites, as well as proactively identifying and addressing quality issues. The Head of Quality will also work closely with CMO(s) to ensure that cGMP related activities meet the company's timelines.Applicants should have a Bachelor’s or higher degree in Biology, Chemistry, or a related Life Sciences degree, with at least 8-10 years of experience working under GMP. Extensive experience in clinical-scale GMP manufacturing and an understanding of phase-appropriate cGMP concepts are essential. The role requires a professional who can provide strategic recommendations, is adept at problem-solving, and can effectively communicate with both internal and external stakeholders. The ideal candidate will be a team player, capable of working in a small team environment that values interdivisional collaboration.

Travel Percent
Less than 10%

Functions

• General Management
• Operations