Quality Auditor

QA Resources Ltd; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

QA Resources Ltd is seeking a highly experienced Quality Auditor to lead GMP audits of external partners across EU and US and to provide independent QP oversight for external manufacturing and supplier activities.

The role is hybrid based in Dublin or Athlone, with extensive travel within US and EU and accountability for audit governance, quality risk management and regulatory readiness in line with EU and US GMP expectations.

Qualifications

• BSc in a relevant scientific discipline required.
• Expert knowledge of pharmaceutical quality systems, manufacturing and analytical operations, with a deep understanding of EU and US GMP regulatory frameworks.
• 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.

Responsibilities

• Lead GMP audits of external partners and suppliers across EU and US locations.
• Oversee supplier qualification and requalification activities and audit schedules.
• Maintain audit and supplier records within the Quality Management System (e.g., TrackWise).
• Provide Qualified Person oversight and input into regulatory compliance activities.
• Support regulatory inspections and authority interactions related to external sites and suppliers.
• Escalate GMP compliance risks and provide risk-based advice to stakeholders.

Skills

Audit leadership

QA systems

Regulatory knowledge

CRO/CMO auditing

Independent judgement

Communication

Teamwork

Analytical thinking

Education

BSc in a relevant scientific discipline

Tools

TrackWise

Job description

QA Resources have an opening for a Quality Auditor in Dublin or Athlone:

Permanent

Role will involve extensive travel within US and EU

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 based in either the Dublin or Athlone office 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.

KEY AREAS OF JOB ACCOUNTABILITY

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.

• API suppliers (where API is supplied but not manufactured on behalf of the company)
• CMO/CDMO Drug Product manufacturers
• CMO/CDMO Storage and Warehousing
• 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.

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.

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, escalation, and communicate significant GMP compliance risks or supplier suitability concerns that may impact product quality, patient safety, or regulatory compliance.

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.

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.

Other tasks as specified

SKILLS & QUALIFICATIONS

• BSc in a relevant scientific discipline 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.