Director of Quality Assurance - Small Molecule CDMO - US Onsite

Posted 19 October 2022
LocationUnited States of America
Job type Full Time
DisciplineSmall Molecule
Contact NameTianna Richards

Job description

​Mantell Associates are currently partnered with one of the most exciting CDMO's globally and as a huge expansion phase they are going through, they are looking for a Director of Quality Assurance.

Are you looking for a step up in your career to join an organisation that will have you reporting to C-Suite level individuals.

Are you tired of not having your ideas heard, respected, and implemented?

​This is the opportunity for you!

Director of Quality Assurance Responsibilities:

  • Interacts with customers and potential customers, as required regarding products, specifications, and returned products.

  • Being the top enforcer for cGMP compliance across departments.

  • Preparing all regulatory submissions such as Drug Master Files, Annual DMF Updates, CMC sections, DEA permits and updates.

  • Back up for all direct report functions

  • Interact with representatives of regulating agencies - internal customer auditors, FDA agent and the Kosher Council Rabbi.

  • Acting as the primary contact for all regulatory audits including FDA inspections, DEA audits, Rabbinical inspections and others.

Director of Quality Assurance Requirements:

  • Minimum B.S. Science or related field, preferably analytical chemistry, with ten years’ experience in a regulated quality assurance environment. Management of personnel.

  • Excellent team player with good communication, analytical and problem solving skills; knowledge of process research and laboratory practices.

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Tianna Richards on +44 (0)20 3854 7731 or tianna.richards@mantellassociates.com.