Lead Auditor

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.