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QC Operations Manager
1 month ago
Autolus Limited is seeking a highly skilled QC Operations Manager to join our team. As a key member of our Quality Control department, you will be responsible for managing and executing all routine testing using validated analytical methods and following prescribed testing plans.
The QC Operations Manager will lead a team of QC scientists, overseeing testing schedules, schedule adherence, and establishing effective communication between all stakeholders. This role requires a strong understanding of GMP regulations and analytical procedure lifecycle.
Key Responsibilities:
- Ensuring adherence to health and safety policies and procedures within the team
- Managing team of QC Scientists (performance assessments, improvement and development plans)
- Establishing SMART objectives for the team members and continuous progress monitoring
- Managing QC schedule (creation, adherence) to ensure timely delivery of results to production and allow timely batch certifications
- Managing workload and capacity for the team and assigning adequate priorities
- Maintaining the QC laboratory in inspection ready state
- Ensuring adequate training level within the team
- Collation and presentation of team metrics
- Maintaining and improving the state of compliance within the team (e.g., adherence to procedures)
- Managing the batch certification process (e.g., data review, approval, quality events)
- Developing and implementing continuous improvement projects
- Looking after the wellbeing of the team
- Coordination of shift activities with Production counterparts
- Cooperation with other QC managers to ensure testing and compliance continuity
- Execution of self-inspections within QC and implementation of CAPA
- Cooperation with Validation and Engineering to ensure GMP status of analytical instruments and QC facilities
- Working closely with QA to efficiently manage all aspects of quality and compliance related to Quality Control
- On call for EMS system in QC laboratory
- Any other duties as required following consultation with the post holder
- Work in adherence to local Health and Safety policies and SOPs
Requirements:
- Min 3 years industry experience as a manager in GxP regulated environment, preferably in ATMPs or Biopharmaceuticals
- BSc/MSc degree in life sciences or significant relevant industry experience
- Excellent spoken and written communication
- Influencing skills
- Excellent time management
- Ability to precisely follow procedures
- Conflict resolution skills
- Familiarity with GMP regulations relevant to Quality Control function
- Familiarity with analytical procedure lifecycle
- Experience with QMS quality events
- Demonstrated experience of representing a function at high level cross-functional meetings with minimal support required
- Highly Proficient in MS Word, Excel, Power Point, DOE and any other relevant applications
- Demonstrated experience in mentorship, supervision, and management of experienced members of team
- Great ability to identify and implement solutions with minimal direction