Director of Quality Assurance - CDMO - Massachusetts (US)

Posted 04 May 2022
SalaryCompetitive
LocationUnited States of America
Job type Full Time
DisciplineLarge Molecule
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 Assurance.

​Key Responsibilities

  • Be thoroughly knowledgeable of Standard Operating Procedures (SOPs), including but not limited to assay and testing procedures, and current Good Manufacturing Practices (cGMPs).

  • Prepare goals for the group on an annual basis.

  • Supervise and guide internal audits of various departments/processes.

  • Oversee and perform QA Document Control activities including processing of change requests, manufacturing records, and other documents.

  • Write, revise, review SOPs and controlled forms and related documents to ensure best practices and current operations.

  • Responsible for completing the disposition of all in-process and finished products, ensuring compliance with all applicable regulations.

  • Oversee supplier quality program and suppliers.

  • Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements in accordance with company policy.

Requirements

  • BS preferred, in a scientific/technical discipline with experience in a quality leadership position within the biological and/or pharmaceutical industry.

  • Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred.

  • Experience with writing Deviations, Lab investigations and OOS required

  • Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities

  • Must be able to assess and utilize software and customized programs to meet QC business needs

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