Senior Product QA Manager

• This is an excellent opportunity to make an impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience.

• 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 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.

• 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.

Team Horizon