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
1. Act as deputy to the Head of QA.
2. Ensure ongoing compliance of the PQS, monitoring control states and process performance.
3. Support the QA team and all departments in investigating and determining appropriate corrective and preventive actions (CAPAs) for quality records.
4. Review quality metrics and trends, lead site management review meetings, and prepare quarterly and annual quality reports.
5. Ensure an efficient change control process that maintains compliance.
6. Conduct QA reviews of batch records, ensuring timely closure of quality records impacting batches.
Qualifications and Experience
1. MSc or equivalent experience in a life sciences discipline.
2. Significant experience as a quality manager within a GMP Quality department, particularly in cell and gene therapy product manufacturing.
3. Proven experience working with regulatory bodies and preparing sites for inspections, including MHRA and/or HTA.
4. Demonstrated ability to manage, develop, and support a team effectively.
5. Strong organizational skills with the capability to prioritize tasks and work under pressure.
6. Ability to engage and influence senior management.
This is an exciting opportunity to join a growing organization, offering a competitive salary and benefits package.
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