* QA CMO Manager, 12-month Contract (MAT Cover)
* Addlestone, Surrey – 1x a quarter on site
* £500 per day – Inside IR35
Cpl Life Sciences is partnering with a growing pharmaceutical company that is looking for a QA CMO Manager on a 12-month basis.
The purpose of the assignment is to maintain CMO oversight/management and associated activities during the maternity leave of the permanent CMO manager.
CMO QA Oversight:
* Oversees the cGMP activities and processes for commercial drug substances, intermediates, and in-process and finished drug products manufactured by CMOs, supported by the line management.
* Provides 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.
* Facilitates the resolution of all deviations, non-conformances and other batch related quality issues with the CMO to ensure product compliance.
* Employs 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 all 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:
* 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
For more information, please reach out to me at lucy.kirkaldy@cpl.com