The Lead GMP Auditor & Qualified Person 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.
The position can be fully office based in either the Dublin or Athlone office or on a hybrid basis. The role is accountable for the governance, execution, and ongoing management of the external audit programme and for maintaining effective GMP oversight of Contract Manufacturing Organisations, Contract Laboratories, suppliers, vendors, and logistics providers, in accordance with EU and US regulatory requirements.
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 senior audit and QP‑qualified oversight roles.
1. Lead GMP Audit Oversight of External Partners and Suppliers
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 includes, but is not limited to:
- CMO/CDMO API manufacturers
- API suppliers (where API is supplied but not manufactured on behalf of the company)
- CMO/CDMO Drug Product manufacturers
- CMO/CDMO Packagers
- CMO/CDMO Storage and Warehousing
- Contract Laboratories
- Raw material and component suppliers
- Transport and third-party logistic providers
External partners are audited based on the GMP impact and scope of activities performed.
2. Supplier Quality Governance & Ongoing Oversight
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.
In addition to leading GMP audits, maintain responsibility for supplier quality management activities, including maintenance of audit and supplier records within the Quality Management System (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.
Issue and review supplier quality questionnaires and assess third‑party audit reports, documenting a Qualified Person evaluation where applicable to support supplier compliance assessments and oversight decisions.
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.
Escalate significant GMP compliance risks or supplier suitability concerns as required and provide expert GMP and Qualified Person input into supplier‑related quality decisions that may impact product quality, patient safety, or regulatory compliance.
3. Qualified Person Regulatory Oversight
Act as a Qualified Person in accordance with EU GMP legislation, 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.
Where required, support regulatory and licensing activities associated with Qualified Person status, including provision of QP declarations and inclusion on manufacturing and/or importation authorisations, as appropriate.
As business needs arise, the role may be required to provide support to QP batch certification activities for non‑sterile products, operating in accordance with approved procedures, defined scope, and in compliance with EU GMP and company quality systems.
Identify, escalate, and communicate significant GMP compliance risks or supplier suitability concerns that may impact product quality, patient safety, or regulatory compliance.
4. Quality Risk Management & Regulatory Compliance
Apply a robust, science and risk‑based approach to GMP oversight of external manufacturing and supply partners, ensuring that quality risks associated with outsourced activities are identified, evaluated, and appropriately managed.
Use quality risk management principles to inform audit planning, supplier qualification and re‑qualification decisions, and ongoing supplier governance activities, taking account of factors such as product type, process complexity, compliance history, deviations, non‑conformances, and inspection outcomes.
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.
5. Contribution to the Quality Management System
Contribute to the effective operation and continuous improvement of the Quality Management System through involvement in quality activities relevant to external supplier oversight and auditing.
Review and assess change controls related to the introduction of new suppliers, changes in supplier scope, or significant changes to supplier organisational structure, ensuring appropriate GMP oversight, audit planning, and risk evaluation.
In preparation for audits and as part of ongoing supplier governance, review relevant supplier deviations, non‑conformances, inspection outcomes, and quality performance trends to inform risk‑based audit scope, supplier qualification decisions, and oversight activities.
Ensure that appropriate policies, procedures, and governance frameworks related to GMP auditing and supplier oversight are established, maintained, and aligned with EU and US regulatory requirements and current regulatory expectations. Provide subject‑matter expertise to support the development, review, and continuous improvement of auditing‑related procedures, including those governing audit execution, reporting, supplier qualification, and oversight activities.
Provide expert GMP and Qualified Person input to quality system activities involving external partners, supporting regulatory compliance, consistency of approach, and sustained inspection readiness across the external manufacturing and supply network.
6. Professional Judgement, Independence & Integrity
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.
The role operates with a high degree of autonomy, integrity, and objectivity, maintaining appropriate independence from operational and commercial pressures. Decisions and recommendations are made based on risk, regulatory requirements, and scientific and quality principles, in alignment with EU GMP and HPRA expectations for senior audit and Qualified Person oversight roles.
Demonstrate sound professional judgement in the identification, escalation, and communication of significant GMP compliance risks or supplier suitability concerns that may impact product quality, patient safety, or regulatory compliance, ensuring transparency and appropriate engagement of relevant quality and regulatory stakeholders.
7. Controlled Substances & DEA‑Relevant Oversight (Audit Scope)
Where applicable, ensure GMP audit oversight includes assessment of controlled substance handling and compliance at external CMOs/CDMOs and suppliers. Audits are conducted under a Quality‑led model, with engagement of relevant subject‑matter experts from Supply Chain/Logistics or EHS/Security to support assessment of DEA‑relevant controls and practices.
This includes evaluation of procedures, controls, Logistics readiness related to controlled substance manufacturing, storage, handling, and distribution, in line with applicable US DEA and relevant international regulatory requirements.
QualificationsBSc in a relevant scientific discipline required.
MSc or postgraduate Qualified Person qualification required.
Demonstrated expert knowledge of pharmaceutical quality systems, manufacturing and analytical operations, with a deep understanding of EU and US GMP regulatory frameworks and their application to external manufacturing and supplier networks.
Minimum of 8 years’ experience in the pharmaceutical manufacturing industry, including at least 4 years’ experience conducting or leading GMP audits of CMOs, CDMOs, and/or suppliers.
Proven ability to lead GMP audits independently, apply risk‑based judgement, and communicate audit outcomes, expectations, and compliance risks clearly and effectively to internal stakeholders and external partners.
Strong professional judgement, integrity, and independence, with the ability to assess complex quality and compliance issues and escalate risks appropriately.
Team‑oriented and quality‑focused, with the ability to collaborate effectively across quality, technical, regulatory, and operational functions.
Highly detail‑oriented, with strong organisational skills and the ability to manage multiple priorities across a complex external supplier network.
Analytical and solution‑focused, with the ability to identify improvement opportunities, evaluate root causes, and drive pragmatic, compliant outcomes.
Adaptable and comfortable operating in a dynamic, fast‑paced environment, with a proactive approach to continuous improvement and regulatory readiness.
Alkermes Dublin, Dublin, IRL Office
Dublin, Ireland
