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Quality Assurance Manager

  1. United States
  1. Permanent
Dependant on Experience
24577AB
  1. Compliance / Quality Assurance
Date Posted13 Mar 2020
I am working with a Biopharmaceutical Contract Manufacturing Organization (CMO) who are looking for a Quality Assurance Manager to work within the Operational side of the business.

The global client is looking for someone looking who wants to take the next step in their career and to grow within a new role.

We are looking for a fast thinking, driven and communicative Quality Assurance Manager to lead a small team of QA Associates.

The successful candidate will have over 5 years of hands on QA experience within a GMP environment and will have acted as a Lead, Supervisor or Manager previously.  

Key Experience:
  • 4 years experience working within a GMP environment.
  • Prior experience Supervising, Leading or Managing a small QA team.
  • QA experience within a Biotech company
  • Experience working within a CMO would be highly desirable.
  • Degree in Science – Biology or Chemistry preferred
Responsibilities:
  • Mentors and provides direction to the QA Operations organization to ensure organization is complying with local and global quality standards, regulatory requirements and partner commitments.
  • Delivery of QA support to the compliant and on-time introduction of GMP programs into manufacturing and disposition of Drug Substance/Product
  • Lead client due diligence and Quality audits as well as supporting regulatory inspections.
  • Continuously improve the processes specified in Standard Operating Procedures and Work Instructions operated by self and direct reports whilst still ensuring the operations meet all current regulatory requirements.
  • Provide cGMP guidance to other functions such as Manufacturing, Facilities and QC.
  • Batch Production Records (completed and approval)
  • Deviation Reports, Corrective Action/Preventive Action Plans and Change Controls
If you are interested in discussing this position, please submit your profile and I will be in contact at my earliest convenience.

The candidate must have the rights to work in the location stated in the job advert.

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