Quality Manager – Contract Operations
This organisation is one of the largest healthcare companies worldwide and employers within Ireland employing more than 4000 people. Manufacturing a broad range of products, including medical devices, pharmaceuticals and diagnostics, this innovative company has numerous manufacturing facilities based in Ireland. A new requirement for a Quality Manager – Contract Operations has arisen.
- Manage TPM’s as assigned from a Quality perspective.
- Approve the Quality/Technical Agreements to align with the legal contracts.
- Implement and maintain a program/project management process to support quality and compliance initiatives at TPMs.
- Participate on QA cross-functional teams to support TPMs, as necessary.
- Participate in long-range planning efforts for capacity (people, systems).
- Co-ordinate the check of regulatory filings by creating RIA and approving change requests generated for external manufacturing of drug products and API’s.
- Travel to off-site locations to ensure and aid the quality infrastructure and appropriate quality systems for alignment to QA Third Party Manufacturing Quality or Technical Agreements.
- Support the management of critical exception documents and CAPA. May act as the primary quality review and decisions maker for relevant TPM exception documents for impact on product quality, safety, efficacy and impact to the regulatory filing.
- Ensure the appropriate GMP requirements are met for the validation of the product, process, equipment and facility. Be the final approver of these documents.
- Coordinate and approval activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.
- Prepare, review and approve Annual Product Quality Reports to ensure accuracy, completeness, timeliness, and those trends are identified and addressed in an appropriate manner.
- Complete management reviews with assigned TPM’s that identify and address quality, operational, and organizational issues.
- Support TPM Quality Heads in providing quality and compliance support/advice for finished dosage form product manufacturing, packaging, and labelling to the TPM’s.
- Provide support for quality audits, initial site approvals.
- Provide support to the QA technical team for manufacturing location(s) of new product introductions or filings.
Education & Experience:
- Bachelor’s degree in a relevant biological or technical discipline is required.
- Masters degree in science or business is preferred, but not required.
- Seven to ten years in a regulated pharmaceutical environment.
- Three to five years project management experience.
To learn more apply on line or call Shane Browne on +353 1 6321865
Salary: On Application
Location: Dublin City Centre