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Senior Manager Product QA

Job Posted: 21 days ago

  • Salary: £ 77,800 - 89,000 / Annum

    Job Type: Permanent

  • Location: Greater Manchester

Expire in: 6 days

Job Description

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?

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