Director of Quality Compliance - CDMO - USA

Posted 19 May 2022
SalaryCompetitive
LocationUnited States of America
Job type Full Time
Contact NameKeisha Lo-Tutala

Job description

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

Mantell Associates is a specialist Pharmaceutical and Life Sciences Executive Search Firm. For more information on this role, please contact Keisha Lo-Tutala on +44 (0)20 3778 0990 or keisha.lo-tutala@mantellassociates.com