CSL
Director, QA Manufacturing
Director, QA Manufacturing
Updated 2 days ago
LiverpoolPermanentOn-SiteFull-TimeLead
Updated 2 days ago
Description
Director, QA Manufacturing
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.
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
In conjunction with the Site Head of Quality Assurance, the role holder provides strong leadership and strategic direction to the Quality Assurance team, mentoring and developing staff both technically and professionally (and if an eligible QP, including acting as a sponsor for trainee QPs). Nurturing a high performing team of quality professionals by clearly defining expectations, holding individuals accountable, managing prioritization/workload allocation, recognizing accomplishments, managing performance, and ensuring professional development. Actively promotes and maintains a cGMP compliant culture, ensuring that the highest standards of quality, housekeeping, and safety are applied 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)
Provide QA/QP (if eligible) oversight of all site operations, and to contribute effectively to the strategic development of company systems. Directly responsible for ensuring implementation and use of Quality Systems for GMP areas in the facility, such as DR/CAPA management, Change Management, document management and training systems.
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 current good manufacturing practices and trends for all markets to which the site distributes product and utilizes this knowledge to implement improvements at the site. Drives adherence to and continuous improvement of the quality systems within their areas of oversight. Interacts with the Regulatory department to maintain QA oversight of new product license submissions and variations. The Head of Front Line QA (and QP, if eligible) is expected to act as a host and/or lead presenter, as required, during regulatory inspections.
Education Requirements
Experience Requirement
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
CSL is an Equal Opportunity Employer.
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.
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
In conjunction with the Site Head of Quality Assurance, the role holder provides strong leadership and strategic direction to the Quality Assurance team, mentoring and developing staff both technically and professionally (and if an eligible QP, including acting as a sponsor for trainee QPs). Nurturing a high performing team of quality professionals by clearly defining expectations, holding individuals accountable, managing prioritization/workload allocation, recognizing accomplishments, managing performance, and ensuring professional development. Actively promotes and maintains a cGMP compliant culture, ensuring that the highest standards of quality, housekeeping, and safety are applied 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)
Provide QA/QP (if eligible) oversight of all site operations, and to contribute effectively to the strategic development of company systems. Directly responsible for ensuring implementation and use of Quality Systems for GMP areas in the facility, such as DR/CAPA management, Change Management, document management and training systems.
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 current good manufacturing practices and trends for all markets to which the site distributes product and utilizes this knowledge to implement improvements at the site. Drives adherence to and continuous improvement of the quality systems within their areas of oversight. Interacts with the Regulatory department to maintain QA oversight of new product license submissions and variations. The Head of Front Line QA (and QP, if eligible) is expected to act as a host and/or lead presenter, as required, during regulatory inspections.
Education Requirements
- Degree in science related field and/or relevant experience
- Postgraduate qualification preferred
- Eligible Qualified Person (QP) preferred
Experience Requirement
- 5 years experience in a QA leadership role, preferably with experience in Sterile manufacture.
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
CSL is an Equal Opportunity Employer.
CSL
Global biotechnology leader developing lifesaving biotherapies, vaccines and treatments for rare diseases
MelbourneBiotechnology1000+Public
CSL
Join a company where your work directly supports therapies that save lives. CSL advances 58 clinical trials, operates award winning plasma fractionation facilities and invests billions in R&D, creating careers where scientific rigour meets patient impact daily.