enior Manager, GMP Auditor (QP highly desirable)

Our client is a highly successful, and ambitious global biopharmaceutical company with a strong commercial portfolio and product development pipeline. They now wish to hire a Lead GMP Quality Auditor within their global team.

The permanent position can be hybrid role, open to various locations within Ireland. This hire must be live and work in Ireland, full-time.

The Senior Manager, GMP Auditor is responsible for providing independent GMP audit leadership and quality oversight of the company’s external manufacturing and supplier network, supporting clinical and commercial products across sterile and non‑sterile operations.

Responsibilities for Senior Manager, GMP Auditor

• The role is accountable for the governance, execution, and ongoing management of the external audit programme and for maintaining effective GMP oversight of CROs, Contract Laboratories, suppliers, vendors, and logistics providers, in accordance with EU and US regulatory requirements. The role operates with a high degree of autonomy, integrity, and objectivity, maintaining appropriate independence from operational and commercial pressures.
• The role provides expert GMP and Qualified Person input to supplier qualification, quality risk management, and regulatory compliance activities, and supports inspection readiness and regulatory authority interactions related to external operations. The position operates with a high degree of professional independence and judgement, consistent with HPRA and EU GMP expectations for a Senior GMP Quality Auditor. Quality Auditor Certification and Qualified Person are highly desirable.
• Provide independent, risk‑based leadership of GMP audits across external suppliers and contract partners supporting clinical and commercial products, including sterile and non‑sterile operations. Audits are performed to EU and US regulatory requirements and support ongoing compliance of the external manufacturing and supply network. The role is accountable for delivery of a robust external audit programme, typically involving 10+ audits per year mainly across US and EU locations.
• The scope of audit oversight of CMO/CDMOs (API manufacturers and suppliers, Drug Product manufacturers, Packagers, Storage and Warehousing), Contract Laboratories, Raw material and component suppliers, Transport and third-party logistic providers, and External partners), who are audited based on the GMP impact and scope of activities performed.
• Provide ongoing GMP quality oversight and governance of external manufacturing and supply partners throughout the supplier lifecycle, ensuring sustained compliance with EU and US regulatory requirements, etc.
• In addition to leading GMP audits, maintain responsibility for supplier quality management activities, including maintenance of audit and supplier records within the QMS (e.g. TrackWise). Ensure that audit outcomes, supplier compliance status, commitments, and corrective actions are appropriately documented, risk‑assessed, and tracked to timely and effective closure.
• Manage supplier qualification and re‑qualification activities, including oversight of audit and supplier re‑qualification schedules, ensuring that CMOs, CDMOs, and suppliers remain suitable for their intended scope of use based on risk, audit outcomes, and regulatory expectations.
• Coordinate and support internal stakeholder engagement related to supplier oversight activities, including organisation and documentation of pre‑audit readiness meetings, ensuring cross‑functional alignment, audit preparedness, and effective communication of audit scope, expectations, and outcomes.
• Providing independent QP oversight and regulatory judgement in support of external manufacturing and supplier activities.
• Provide QP assessment and evaluation of GMP compliance at external sites, including review of audit outcomes, third‑party audit reports, supplier risk assessments, and quality system effectiveness, ensuring alignment with EU GMP requirements and the principles of Annex 16.
• Maintain current knowledge of EU and US GMP legislation, HPRA and EMA expectations, and relevant regulatory guidance, and apply this knowledge to audit strategy, supplier oversight, and Qualified Person assessments.
• Support regulatory inspections, audits, and authority interactions related to external sites, suppliers, and products, including inspection preparation, provision of subject‑matter expertise during inspections, and input to regulatory responses and commitments where required.
• Contribute to the effective operation and continuous improvement of the QMS through involvement in quality activities relevant to external supplier oversight and auditing.
• Exercise independent professional judgement in the assessment of GMP compliance, supplier suitability, audit outcomes, and quality risk decisions associated with external manufacturing and supply partners.
• Ensure GMP audit oversight includes assessment of controlled substance handling and compliance at external CMOs/CDMOs and suppliers.