Lead Auditor

QA Resources Ltd; Cork; Ibrido; EUR 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

QA Resources Ltd in Ireland seeks a Quality Audit & Inspection Readiness lead on a 12-month initial contract, hybrid in East Cork. You will lead a risk-based internal audit programme and an site-wide inspection readiness strategy to ensure sustained GxP compliance and successful regulatory inspection outcomes.

Responsibilities include developing risk-based audit plans (7–10 audits per year), overseeing GMP, validation, data integrity audits, coaching SMEs, coordinating mock inspections with

Competenze

• 8–12+ years' experience in pharmaceutical manufacturing, QA or compliance.
• Extensive experience leading and supporting regulatory inspections.
• Strong GMP, validation and data integrity expertise.
• Lean Six Sigma Black Belt qualification.

Mansioni

• Audit Leadership: develop and execute a risk-based internal audit plan and oversee high-risk audits.
• Inspection Readiness: own and lead site inspection readiness strategy and mock inspections.
• SME Coaching: design and deliver GMP inspection readiness training and coach SMEs.
• Regulatory Oversight: review audit responses, CAPA plans and regulatory responses.
• Data-Driven Risk: oversee analytics-driven audit planning and trend quality metrics.
• Process Design: design, standardise and deploy internal audit and inspection processes.

Conoscenze

Audit leadership

Data-driven risk

Stakeholder engagement

Regulatory inspections

GxP compliance

Data integrity

GMP expertise

Lean Six Sigma Black Belt

Formazione

Science degree

Pharmacy degree

Engineering degree

Descrizione del lavoro

QA Resources have an opportunity for Quality Audit & Inspection Readiness (GxP)role to be based on client site in East Cork:

12 month initial contract, hybrid option

To lead and deliver a risk-based internal audit programme and a site-wide inspection readiness strategy, ensuring sustained compliance with global GxP requirements and successful regulatory inspection outcomes.

Key Responsibilities

Audit Leadership

• Develop and execute a risk-based internal audit plan (typically 7-10 audits per annum minimum).
• Lead and oversee high-risk audits including, but not limited to, data integrity, aseptic processing, and validation.
• Ensure audit findings are robust, risk-based, inspection-ready, and aligned with regulatory expectations.

Inspection Readiness Programme

• Own and lead the site inspection readiness strategy.
• Plan, conduct, and oversee mock inspections aligned to global regulatory authorities, including the FDA and EMA.
• Act as a key advisor and quality representative during regulatory inspections.

SME Coaching & Capability Building

• Design and deliver inspection readiness and GMP capability training.
• Coach Subject Matter Experts (SMEs) on inspection behaviour, response delivery, and documentation presentation.

Regulatory Response Oversight

• Review and approve audit responses, CAPA plans, and regulatory responses.
• Ensure all responses are root cause-driven, scientifically sound, and regulatorily robust.

Data-Driven Risk Management

• Oversee analytics-driven audit planning activities.
• Review and trend site quality metrics including deviations, CAPA, OOS, and OOT data.
• Identify emerging compliance risks and areas requiring proactive intervention.

Process Design and implementation Management

• Accountable for the design, standardisation, and deployment of internal audit and inspection readiness processes.
• Translates regulatory requirements into clear, scalable, and sustainable site processes.
• Leads process effectiveness reviews, ensuring:
• Clear ownership and governance
• Defined interfaces with Quality Systems (CAPA, Deviations, Change Control)
• Embedded risk based decision making
• Drives process maturity from reactive compliance to proactive, predictive assurance.

Qualifications & Experience

• Degree in Science, Pharmacy, Engineering, or a related discipline.
• 8-12+ years' experience in pharmaceutical manufacturing, QA, or compliance roles.
• Extensive experience leading and supporting regulatory inspections.
• Strong expertise in GMP, validation, and data integrity requirements.
• Lean Six Sigma Black Belt qualified

Key Skills & Competencies

• Strategic leadership and decision-making.
• Advanced regulatory and technical writing capability.
• Ability to influence and engage senior stakeholders.
• Coaching, mentoring, and facilitation skills.
• Strong risk-based and data-driven mindset.