Director - GMP Compliance

Director - Gmp Compliance

Our client - a growing pharmaceutical company located in Central NJ - is looking for a Director - GMP Compliance. The Director - GMP Compliance plays a crucial role in the organization ensuring that all interactions adhere to quality compliance and meet regulatory standards. They will assume ownership of cGMP compliance training as well as carry out audits on various manufacturing units, contract manufacturers and vendors in order to maintain inspection readiness with relevant agencies such as FDA or DEA.

The Director - GMP Compliance will:

• Ensure cGMP readiness and compliance to guarantee the quality of our products, processes and procedures meet all applicable standards.
• Establish policies, guidelines and systems necessary for a successful adherence to regulatory requirements that aligns with company objectives.
• Implement strategies to manage any foreseeable risks in order uphold an unwavering commitment towards maintaining product safety & efficacy as well as complying with industry regulations.

The ideal applicant for this role will have a Bachelor of Science in Chemistry or related field, as well as over 10 years experience auditing and ensuring compliance within cGMP regulated pharmaceutical manufacturing environments. Furthermore they should be knowledgeable regarding domestic and international regulations surrounding such organizations; have a thorough understanding of quality programs; plus the ability to manage small-medium sized teams.