Mantell Associates is currently partnered with a leading CDMO based in the US, in their search for a Director of Quality Compliance.
Director of Quality Compliance - Key Responsibilities:
A strong understanding of standards, guidelines, and FDA/EU regulations and ensure compliance with all regulatory standards, systems, procedures and practices.
Evaluate all current Quality systems/processes and recommend/implement appropriate enhancements.
Provide strategic directions and technical guidance on regulatory requirements, changes, and compliance improvements.
Establish and maintain a positive working relationship with clients, the FDA, and other regulatory authorities.
Strong project management knowledge, including complex projects with multiple team members and independent coordination with the client.
Director of Quality Compliance - Requirements:
BS in science/ engineering or equivalent
Experience in Quality, Manufacturing, and Engineering or related field which should include a minimum of 3 years of supervisory experience
Must have experience in interacting with regulatory authorities and excellent working knowledge of GMPs, including interpretation and application of regulations across pharmaceuticals and biologics
Good project manager skills