Quality Assurance Compliance Manager

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom AdventBio Full time
Quality Assurance Compliance Manager

We are seeking a highly skilled Quality Assurance Compliance Manager to join our Quality Assurance Department at Advent Bioservices.

About Us

Advent Bioservices is a leading Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of Advanced Therapy Medicinal Products (ATMPs) and related products, process development, and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market.

Job Summary

The main purpose of this role is to lead the establishment of a quality framework for effective use in manufacture of 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.

Key Responsibilities

  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

Requirements

  • MSc or equivalent experience in a life sciences subject
  • Significant experience working as a quality manager within a GMP Quality department in the manufacture of cell and/or gene therapy products
  • Experience of working with regulatory bodies and preparing sites for regulatory inspection
  • Experience of managing, developing, and supporting a team
  • Strong organisational skills with the ability to prioritise and work under pressure
  • 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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