Jenn at Wallace Myers is currently partnering with a key global client to source a Senior Product QA Manager for their state-of-the-art facility in Sligo. This is a full-time, permanent staff role where you'll be joining a site at the forefront of innovation. If you're looking for a move that combines global impact with the lifestyle benefits of the Northwest, lets chat!

Senior Product QA Manager.
This leadership role ensures that all products manufactured at this site meet the requirements of end users, regulatory authorities (including FDA and HPRA), and company standards. The Senior Product QA Manager is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs).

• QP experience essential
• Strong people leadership experience

Responsibilities:

• Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management.
• Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems.
• Lead batch review and release, documentation, checks, and test completion.
• Oversee validation of manufacturing and testing processes and accurate record keeping.
• Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications.
• Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches.
• Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA).
• Chair Change Review Boards, approve changes, oversee completion of QA tasks.
• Conduct internal/external audits and participate in regulatory/customer inspections.
• Manage complaint investigations, coordinate product recalls, and address quality defects.
• Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and AbbVie QA Policies.
• Review and approve Product Quality Reviews (PQRs) and track finished product data.
• Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics.
• Act as Designee for the Quality Director when required.
• Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making.

QUALIFICATIONS

• MSc in Industrial Pharmaceutical Science (or a comparable course recognized for QP status per Article 49 of Directive 2001/83/EC).
• Minimum 10 years' experience in the healthcare/pharma sector within FDA/EMA approved environments.
• Demonstrated experience leading teams, with 7 years in leadership roles
• Demonstrated attention to detail, strong problem-solving and innovative thinking abilities.
• Results-driven mindset with proven prioritization skills and commitment to quality.
• High integrity, strong work ethic, excellent verbal/written communication, and interpersonal skills.

All applications will be treated with the strictest of confidence
Contact Jenn Dinan on 014408352 and email

At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.

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