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QA Director
- Liverpool, England, United Kingdom
- Liverpool, England, United Kingdom
À propos
Liverpool | Senior Leadership Role | Salary Confidential
About the Role
We are seeking an experienced Director, QA Manufacturing (Head of Front Line QA) to take ownership of a well-established Quality function within a sterile manufacturing environment.
Reporting to the Site Head of Quality Assurance, this is a senior leadership role responsible for providing independent QA oversight across all site operations, while shaping quality strategy, governance, and culture. You will lead a high-performing QA team delivering 24/7 operational support, ensuring that all products and processes meet the highest standards of cGMP, regulatory compliance, and data integrity.
For candidates eligible to act as a Qualified Person (QP), the role also carries responsibility for certification and release of products, including oversight of manufacturing and intermediate product release.
What You'll Be Responsible For:
Front Line QA Operations
Provide QA oversight across manufacturing, QC, engineering, and GMP operations Lead a team delivering continuous QA support to production operations Ensure robust systems for batch review, QA processes, and QA IT systems
QP Responsibilities
Certify or reject product for release in line with regulatory and legal requirements Provide oversight of product release across the manufacturing lifecycle Maintain QP eligibility through ongoing professional development
Quality Leadership & Strategy
Lead and develop a large QA team, setting clear direction, expectations, and performance standards Promote a strong quality culture and cGMP mindset across the organisation Act as a deputy to the Site Head of QA and contribute to overall site strategy Define and track quality KPIs and performance metrics
Quality Systems & Governance
Oversee the Pharmaceutical Quality System (PQS), including: Deviations, CAPA, and Change Management Document management and training systems Data integrity and compliance frameworks Ensure the site remains inspection-ready at all times Support management review processes and continuous improvement of quality systems
Operational & Cross-Functional Oversight
Provide QA leadership across key governance forums, including: Deviation Review Boards Change Review Panels Quality Management Reviews Collaborate with Supply Chain, External QA, and Contract Manufacturing teams Ensure compliant handling of all product across manufacturing, distribution, and third parties
Regulatory & External Engagement
Act as a key contact during regulatory inspections and audits Engage with regulatory authorities and ensure compliance with global GMP standards Support regulatory submissions, variations, and ongoing compliance requirements
About You:
You are a senior quality leader with deep experience in GMP-regulated manufacturing, ideally within sterile or aseptic environments.
You'll bring:
Significant experience in QA leadership roles within pharmaceutical manufacturing Strong knowledge of cGMP, regulatory frameworks, and quality systems Proven ability to lead teams, manage complexity, and drive quality performance Eligibility to act as a Qualified Person (QP)Highly desirable:
Experience within sterile or aseptic manufacturing environments Experience leading QA functions in 24/7 operational settings Track record of supporting regulatory inspections and audits
Location & Working Pattern
Based on-site in Liverpool Senior leadership role with high on-site presence required Engagement across operational, strategic, and regulatory activities
The Opportunity
This is a rare opportunity for an experienced quality leader to step into a highly visible, business-critical role, taking ownership of an established QA function while driving forward quality excellence, regulatory compliance, and operational performance in a complex manufacturing environment.
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy
Compétences linguistiques
- English
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