Due to continued growth, our CDMO client is looking for an experienced Quality Manager to join its team. Leading a team of 3, you must have previous experience in a leadership role. Previous experience working in an ATMP or Gene Therapy manufacturing environment is essential.

Job Summary

You will spearhead the development of a robust quality framework for the manufacturing of Advanced Therapy Medicinal Products (ATMPs) within our expanding CDMO. This role is pivotal in fostering a culture of regulatory compliance, continuous quality improvement, and quality awareness through a risk-based Pharmaceutical Quality System (PQS). You will lead a dedicated team of quality professionals while collaborating with various departments across the organization.

In this role, you will oversee risk management, change control processes, and non-conformance management, ensuring compliance with the requirements of our diverse clientele and regulatory authorities. You will maintain the PQS in a state of control, identify and monitor trends, and present these findings in site management reviews.

Key Responsibilities

• Act as deputy to the Head of QA.
• Ensure ongoing compliance of the PQS, monitoring control states and process performance.
• Support the QA team and all departments in investigating and determining appropriate corrective and preventive actions (CAPAs) for quality records.
• Review quality metrics and trends, lead site management review meetings, and prepare quarterly and annual quality reports.
• Ensure an efficient change control process that maintains compliance.
• Conduct QA reviews of batch records, ensuring timely closure of quality records impacting batches.

Qualifications and Experience

• MSc or equivalent experience in a life sciences discipline.
• Significant experience as a quality manager within a GMP Quality department, particularly in cell and gene therapy product manufacturing.
• Proven experience working with regulatory bodies and preparing sites for inspections, including MHRA and/or HTA
• Demonstrated ability to manage, develop, and support a team effectively.
• Strong organizational skills with the capability to prioritize tasks and work under pressure.
• Ability to engage and influence senior management.

This is an exciting opportunity to join a growing organization, offering a competitive salary and benefits package