Quality Control Director - Biotech

Posted 06 March 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
Discipline Large Molecule
Contact NameJarel Jack

Job description

​Mantell Associates are currently partnered with a leading biotech, in their search for a Quality Control Director. This person will be responsible for organising and ensuring the successful operation of the Quality Control function at the site. This role will suit someone who has extensive experience in QC within a Large Molecule biotech/CDMO, and is looking to take a step into leadership.

Quality Control Director Responsibilities:

  • Build and oversee team of QC analysts through effective planning, mentoring, directing and coordination of GMP testing activities

  • Lead and facilitate initial and periodic training of QC analysts to ensure adherence to laboratory practices, techniques, and GMP requirements

  • Oversee the scheduling of raw material, in-process, release, and stability testing in a manner such that supports the manufacturing schedule

  • Communicate and enforce laboratory quality requirements to all personnel working in the lab and ensure that they are completed per GMP requirements

Quality Control Director Requirements:

  • Must have experience with cGMP and quality systems including OOS investigations, deviations, change control and CAPAs

  • Ability to work independently and stay on task in a fast-paced environment without direct supervision

  • High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines

  • Technical and quality event writing experience in order to accurately depict program goals and execute root cause analysis and mitigation critical thinking

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Jarel Jack on +44 (0)20 3854 7700 or jarel.jack@mantellassociates.com.