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 ...