Senior QA Specialist

Purpose of the Position / Role Summary

The Senior QA Specialist provides advanced QA leadership and oversight of external Contract Manufacturing Organisations (CMOs), Contract Testing Laboratories (CTLs), third-party logistics partners (3PLs), and Bimeda QMS. With significant experience in pharmaceutical and/or biopharmaceutical QA, the Senior QA Specialist ensures that all products manufactured, tested, released, and distributed comply with cGMP/GDP, Marketing Authorisations, regulatory expectations, and Bimeda quality standards.

Key Role Specific Requirements

CMO & Contract Partner Quality Oversight

• Maintain quality oversight of CMO, CTL, & 3PL partners as per quality technical agreement.


• Independently lead recurring Quality Business Reviews with CMOs, CTLs and 3PL partners.


• Approve validation protocols/reports and sampling strategies.


• Lead and participate in CMO/contract lab audits.


• Maintain quality oversight of CMO Stability program


• Oversee QC method transfers and data integrity requirements.

Quality Management System (QMS) Ownership

• Maintain and strengthen the SMF.


• Support Bimeda departments with their Change Controls, Deviations, CAPAs, and batch-related quality records.


• Ensure final approval of Change Controls, Deviations, CAPAs in a timely manner


• Lead internal audits and QMS KPI tracking.


• Support Bimeda QPPV program.


• Drive closure of vendor and customer complaints.
  
  

Product Lifecycle & Technical Activities

• Conduct expert QA review and approval of CMO validation protocols and reports.


• Coordinate FP and RM testing via CMOs/CTLs.


• Support Artwork approval process.

Complaints, Deviations & Investigations

• Lead high-complexity investigations across complaints and deviations.


• Drive RCA, risk assessments, and CAPA effectiveness verification.


• Compile and present Product Quality Reviews.

Regulatory Interface & Recall Readiness

• Provide expert QA input to HPRA and other HA notifications.


• Maintain and lead Recall Readiness activities.


• Support licence variations and regulatory inputs.

Samples, Records & Archiving

• Own the Reference and Retain Samples programme: define storage locations/conditions, chain of custody, retention periods and retrieval; ensure alignment with MA/HPRA expectations and BAHL SOPs.


• Oversee Archiving Documentation for CMOs and contract labs to ensure complete product histories and inspection‑readiness.

Training & SOP System

• Maintain and author SOPs, CMO Questionnaires, and related controlled documents; ensure version control and training assignment.


• Deliver QA Training (data integrity, documentation, investigations, change control); track effectiveness.


• Provide inputs to Management Review on QMS performance and training compliance.

Meetings, Reviews & Cross‑Functional Collaboration

• Lead quality meetings with CMOs/CTLs.


• Represent QA during audits and inspections.


• Maintain strong cross-functional and external relationships.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Requirements

Essential:

• BSc in a scientific discipline.


• Knowledge of pharmaceutical QA methodologies, cGMP, Quality Systems, Analytical Chemistry.


• High integrity; excellent attention to detail; analytical thinker; organised; team‑oriented; self‑starter.


• 10 years relevant experience in a regulated pharmaceutical environment (QA/QC).

Desirable:

• MSc in Quality Assurance


• Experience with external manufacturing/CMO oversight and contract lab management.


• Familiarity with HPRA, EU GMP/GDP, and product lifecycle documentation (SMF, PQR).


• Working knowledge of sampling standards (e.g., ANSI/ASQ), stability/IQ‑OQ‑PQ, and data integrity (ALCOA+).


• Strong communication skills to manage partner relationships and drive timely closure of quality actions.

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s eight manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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