Overview
QA CMO Manager on a 12-month contract (MAT cover) with Cpl Life Sciences partnering with a growing pharmaceutical company. The purpose of the assignment is to maintain CMO oversight/management and related activities during the maternity leave of the permanent CMO manager.
Responsibilities
* QA CMO Oversight: oversee cGMP activities and processes for commercial drug substances, intermediates, in-process and finished drug products manufactured by CMOs, supported by line management.
* Provide QA oversight for technology transfers of commercial products to and between CMOs.
* Provide QA support for regulatory agency inspections at CMOs as necessary.
* Participate in CMO Business Review Meetings.
* Facilitate the resolution of all deviations, non-conformances and other batch-related quality issues with the CMO to ensure product compliance.
* Employ a Risk Management approach to evaluate quality issues to ensure that drug substances, intermediates, and in-process and finished drug products manufactured by CMOs conform to regulatory and business product specifications.
Interactions
* Internal: Product and Project management; CMC RA; Quality Assurance; Legal; Supply Chain; Technology and Manufacturing
* External: Contract Manufacturing Organizations
Prior Experience / Qualifications
* Influencing: ability to communicate with stakeholders, clearly provide QA assessments, reasoning and align to consistently ensure compliance and patient safety
* Decision making
* Project management
* Previous experience in pharmaceutical Quality Assurance, CMO oversight or in-plant GMP pharmaceutical manufacturing
* Experience working with Biologics
How to apply
For more information, please reach out to me at lucy.kirkaldy@cpl.com
Job Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industries: Pharmaceutical Manufacturing and Biotechnology Research
Locations mentioned: London; Leatherhead; Reading; Bracknell; Aldershot; Maidenhead; Surrey; Greater London (UK postings)
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