CMO Quality Compliance Manager (9 month secondment)
- Education (minimum): BA/BS in Pharmaceutical or Science/Chemistry and/or equivalency in education.
- Experience (minimum):
3-5 years of operational experience in various Quality Assurance roles (Quality Manager or Quality Control Manager).
- Experience on a manufacturing site or with external partners (contractors).
- Experience with managing contractor Quality Agreements would be a plus for this role.
- Project Management and leadership skills.
- Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment.
- Previous assignment experience promoting or requiring regional or global perspective desirable.
Reporting to the CMO Quality Compliance Lead, the primary responsibilities of this role are to support and coordinate the Quality Agreement initiatives within the CMO Organization to ensure compliance of Third Party Sourced products with the GSK Quality Management System and all relevant regulatory and legislative requirements.
The main job purpose is :
- Work with CMO QA to establish, harmonize, and update CMO CH Quality Agreements between GSK and our contractors.
- This includes working with our local Quality Relationship Managers (QRM) and Quality Heads to determine a baseline of the current CMO CH QAAs situation. This includes, but not limited to, establishing a GAP analysis(s), execution of plans to have approved QAA Part B's for all products across GSK's CMO CH portfolio, as well as to ensure that Part A Quality Agreements are current.
- This position is a proactive initiative as it will require the person to work across the whole organization to align this process.
- Additionally, this position will require the person to work directly with QMs to draft, edit, update, QAAs as required. Therefore demonstrated experience working with contractors and associated agreements is a preferred competency. This also includes the coordination and tracking of documentation for approval, as well as following the proper document storage strategies according to GSK standards.
- During the assignment, periodic reporting of the status of activities will be required as well as tracking of QAA statuses. Therefore, demonstrated project management experience is a preferred competency for this position. Contract negotiation with contractors will be performed by QMs.
- This position will require the on boarded contractor to maintain their assigned training as regulations require.
The CMO Quality Compliance Manager undertakes the following responsibilities:
- Leads the QAA update initiative with the CMO Quality Manager.
- Perform gap assessment between current QAA and new template.
- Define and align priorities to update QAA with the CMO Quality Manager & LOC QA.
- Support the preparation and management of our QAAs, as appropriate.
- Tracks and reports on the status of the project to QA Governance. Escalates any issues or delays during Regional Quality Council.
You may apply for this position online by selecting the Apply now button.
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