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 email@example.com.