QA Director - #2085470

Director, QA Manufacturing (Head of Front Line QA / QP)

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.