Company Information
Advent Bioservices is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using advanced therapy medicinal products. We currently manufacture in aseptic suites at our MHRA and HTA licensed facility in Sawston, Cambridge.
Job Summary
Based in Sawston, the main purpose of this role is to lead the establishment of a quality framework for effective use in manufacture of Advanced Therapy Medicinal Products (ATMPs), in a continuously growing and expanding CDMO. This role includes responsibility for developing Advent Bioservices' culture of regulatory compliance, continuous quality improvement and quality awareness in a risk-based Pharmaceutical Quality System (PQS), leading a small team of quality staff, and liaising with staff across the various departments within the company.
The QA Compliance Manager will be responsible for monitoring, controlling and overseeing risk, change control processes and non-conformance management within the company, ensuring that they meet the requirements of multiple clients and regulatory authorities. The job holder will also be responsible for ensuring that the PQS is always in a state of control, for identifying and monitoring trends, and reporting such trends within the site management review.
Key responsibilities will include:
1. Deputise for Head of QA
2. Ensure the PQS is in a state of compliance, monitoring the state of control and process performance
3. Support QA team and all departments on appropriately investigating and identifying correct CAPAs for any quality record
4. Review metrics and trends, lead site management review meetings and produce/review quarterly and annual quality reports
5. Ensure change control process allows for compliance through smooth operation of the change control process
6. QA review of batch records, ensuring prompt closure of quality records that impact the batch
The successful candidate will have the following experience/qualifications:
1. MSc or equivalent experience in a life sciences subject
2. Significant experience working as a quality manager within a GMP Quality department in the manufacture of cell and/or gene therapy products.
3. Experience of working with regulatory bodies and preparing sites for regulatory inspection
4. Experience of managing, developing and supporting a team
5. Strong organisational skills with the ability to prioritise and work under pressure
6. Ability to engage and influence at senior management level
This is a fantastic opportunity to join a growing organisation. We offer an attractive base salary and benefits package.
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