Senior Manager Product QA

Team Horizon is seeking a Senior Product QA Manager & QP to join our client’s team. This is a leadership role and is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs).
Relocate?
* This role is a fully on-site position in Ireland, are you willing to relocate?
* Do you have authorisation to work in the EU?
Why you should apply:
* This is an excellent opportunity to make an impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience.
What you will be doing:
* 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.
What you need to apply:
* 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.
Relocate?
* This role is a fully on-site position in Ireland, are you willing to relocate?
* Do you have authorisation to work in the EU?