Director, QA Manufacturing

Responsibilities

• Front Line QA Operations
• The role holder is responsible for providing direct Quality oversight across all Manufacturing, QC, Engineering and supporting operational areas. This includes Quality support for projects, initiatives, and routine activities associated with all GMP operations on site.
• They lead a team that delivers 24/7 QA coverage to Primary and Secondary manufacturing, ensuring continuous quality presence and timely decision-making to maintain compliant and efficient operations.
• The role is accountable for the site processes governing QA Batch Review and QA IT, ensuring these systems are robust, effective, and fully aligned with applicable regulations, cGMP requirements, and current industry best practice.
• QP Responsibilities, if eligible
• The role holder is responsible for certification and/or rejection of product destined for release to market in compliance with applicable licences and legal requirements.
• The role holder must maintain eligibility to act as a QP by completing Continuous Professional Development (CPD)
• QA Leadership
• within with team. The role holder will be an official delegate for the Site Head of Quality Assurance.
• The role holder supports the management and development of the Pharmaceutical Quality system (PQS), including Management Review, ensuring compliance with regulatory requirements, company procedures and industry best practice. The role holder ensures that quality systems consistently
• support compliant product release, reliable data integrity, and sustained inspection readiness across the site.
• As a leader within Quality Assurance, the role holder must establish quality objectives and associated
• Key Performance Indicators (KPIs) for the Front Line QA function and must ensure that these objectives
• are met.
• Operational Responsibilities (Local)
• Locally, the QP (if eligible) must provide oversight of key site meetings / publications, such as Local
• Quality Management Review, Deviation Review Board, Change Review Panel, Site Stability Meeting, Continuous Process Verification, Campaign Management meetings and Regulatory planning meetings.
• Operational Responsibilities (External)
• In addition to local responsibilities, the role holder must integrate with External Supplier Quality, Supply Chain QA and Contract Manufacturing QA management to provide oversight of GMP suppliers, third-party distributors and contract manufacturing operations.
• Support and guidance must be given relating to key quality decisions impacting the manufacturing and movement of in-process, quarantined and fully released product under the QPs responsibility.
• Regulatory
• Develop and maintain a relationship with regulatory authorities (e.g. Health Authorities and Official Medicines Control Laboratories). including participation in the inspection process site audits as appropriate and oversight of BPDRs/notifications.
• Acquires and maintains knowledge of local and international regulatory and legislative requirements for pharmaceutical

Benefits

Additional Information

Reporting to the Site Head of Quality Assurance, the Head of Front Line QA (and QP, if eligible) provides independent QA/QP oversight for all operations at Seqirus Liverpool, as well as support to commercial affiliates and contract manufacturers per approved Quality Agreements. The role leads and develops the Front Line QA function to ensure pharmaceutical quality across all products manufactured, tested, distributed and/or released at the site, ensuring compliance with all regulatory, quality and internal requirements. When acting as a QP (if eligible), the role holder is responsible for certification and release of commercial and clinical products, and for oversight of intermediate product release throughout the manufacturing process. The Head of FLQA shapes site quality culture and strategic direction, ensuring robust quality systems and standards are in place and effectively applied in alignment with regulatory expectations

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