Senior Manager of Quality Control Operations
3 weeks ago
Job Title: Manager, QC Operations
Responsibilities
Key Responsibilities:
- Ensure adherence to health and safety policies and procedures within the team.
- Manage a team of QC Scientists, including performance assessments, improvement and development plans.
- Establish SMART objectives for team members and monitor continuous progress.
- Manage the QC schedule to ensure timely delivery of results to production and allow timely batch certifications.
- Manage workload and capacity for the team, assigning adequate priorities.
- Maintain the QC laboratory in an inspection-ready state.
- Ensure adequate training within the team.
- Collate and present team metrics.
- Maintain and improve compliance within the team, adhering to procedures.
- Manage the batch certification process, including data review, approval, and quality events.
- Develop and implement continuous improvement projects.
- Care for the wellbeing of the team.
- Coordinate shift activities with Production counterparts.
- Cooperate with other QC managers to ensure testing and compliance continuity.
- Execute self-inspections within QC and implement CAPA.
- Cooperate with Validation and Engineering to ensure GMP status of analytical instruments and QC facilities.
- Work closely with QA to efficiently manage all aspects of quality and compliance related to Quality Control.
- Be on call for the EMS system in the QC laboratory.
- Perform any other duties as required, following consultation with the post holder.
- Work in adherence to local Health and Safety policies and SOPs.
Requirements
Experience: Min 3 years industry experience as a manager in GxP regulated environment, preferably in ATMPs or Biopharmaceuticals.
Qualifications: BSc/MSc degree in life sciences or significant relevant industry experience.
Skills/Specialist knowledge:
- Open to working shifts.
- Attention to detail.
- Meet requirements to work in a cleanroom environment.
- 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 (validation, tech transfer, verification).
- Familiarity with regulations governing stability testing and shelf-life management.
- Familiarity with analytical equipment qualification lifecycle.
- Experience with QMS quality events (application, conduct, timely closure).
- 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 a team.
- Great ability to identify and implement solutions with minimal direction.
- Technical background in Quality Control for ATIMPs.
Language: English
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