​Senior QA Manager – CRDMO

Posted 09 February 2023
Salary Negotiable
LocationUnited States of America
Job type Full Time
Discipline Large MoleculeSmall Molecule
Contact NameLuke Heath

Job description

Mantell Associates is currently partnered with one of the most exciting up-and-coming and rapidly expanding CRDMOs on the market in their search for a new Senior QA Manager.

Are you looking to join a dynamic company with massive opportunities for future career progression?

Do you want to establish yourself as you help take a top quality organisation to the next level?


Senior QA Manager Responsibilities:

  • Develop and oversee the New Product Introduction (NPI) process responsible for onboarding new customers and products to ensure successful clinical and commercial drug product manufacturing

  • Develop and oversee the Product Quality Team responsible for disposition of batches

  • Provide strategic guidance to resolve complex investigations and product quality issues

  • Reviews and approves Commissioning and Validation protocols and final reports

  • Reviews and approves Formulation/Development protocols and final reports

  • Leads continuous improvement projects for Quality Assurance

  • Quality lead for client audits and regulatory inspections

  • Provide support during internal audits

  • Communicate clearly with cross-functional teams


Senior QA Manager Requirements:

  • Master’s Degree and 5+ years’ experience in Quality Assurance leadership in a GMP related field within a Biotechnology, Biologics, or Pharmaceutical manufacturing facility or Bachelor’s Degree and 10+ years’ experience in Quality Assurance in a GMP related field within a Biotechnology, Biologics, or Pharmaceutical manufacturing facility

  • Must have proven track record with batch disposition activities

  • GMP compliance knowledge including 21CFR210, 211, 820, as well as EMA Annex 1 and FDA Guidance on Aseptic Processing

  • Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, eQMS and LIMS systems, preferred

  • Experience in managing a team


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