Manager, QC Operations

TN United Kingdom; Stevenage; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Quality Control Manager to lead a dynamic team in a GxP regulated environment. This full-time role involves overseeing QC operations, ensuring compliance, and managing a shift-based schedule. The successful candidate will drive team performance, implement continuous improvement projects, and maintain high standards of quality and safety. If you are passionate about quality control and thrive in a collaborative environment, this is an exciting opportunity to make a significant impact in the biopharmaceutical sector.

Qualifications

• 3+ years experience as a manager in a GxP regulated environment.
• BSc/MSc in life sciences or significant relevant industry experience.

Responsibilities

• Manage QC team performance and development plans.
• Ensure adherence to health and safety policies.
• Coordinate shift activities with production counterparts.

Skills

Team Management

Communication Skills

GMP Regulations

Analytical Procedures

Problem Solving

Mentorship

Cleanroom Environment

Education

BSc/MSc in Life Sciences

Relevant Industry Experience

Tools

MS Word

Excel

Power Point

DOE Applications

Job description

Social network you want to login/join with:

Quality Control Operations manages and executes all routine testing using validated analytical methods and following prescribed testing plans. Test results allow to monitor and drive the manufacturing processes, release the product or material, determine shelf life of the product or material and assess potency, quantity, identity and safety against defined specifications.

QC manager (Operations) leads a team of QC scientists covering one of 4 shifts. Job holder is responsible for efficient provision of QC services to production and other internal and external customers by overseeing testing schedules, schedule adherence and establishing effective communication between all stakeholders. QC managers monitor, maintain and improve compliance within the team and across the department. QC managers interact with multiple functions within the business to guarantee smooth and concise information exchange.

Please note, that this is a full-time shift-based role covering either Sunday to Wednesday / Wednesday to Saturday with bi-weekly shift rotation between earlies (6AM - 345PM) and lates (1215PM -10PM).

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

Demonstrated skills and competencies

P – Preferred

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 (P) or significant relevant industry experience

Skills/Specialist knowledge

• Open to working shifts (E)
• Meet requirements to work in cleanroom environment (P)
• Excellent spoken and written communication (E)
• Ability to precisely follow procedures (E)
• Familiarity with GMP regulations relevant to Quality Control function (E)
• Familiarity with analytical procedure lifecycle (validation, tech transfer, verification) (P)
• Familiarity with regulations governing stability testing and shelf-life management (P)
• Familiarity with analytical equipment qualification lifecycle (P)
• Experience with QMS quality events (application, conduct, timely closure) (E)
• Demonstrated experience of representing a function at high level cross-functional meetings with minimal support required (E)
• Highly Proficient in MS Word, Excel, Power Point, DOE and any other relevant applications (E)
• Demonstrated experience in mentorship, supervision, and management of experienced members of team (E)
• Great ability to identify and implement solutions with minimal direction (E)
• Technical background in Quality Control for ATIMPs (P)

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Check our Blog for more information.

Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Created on 26/04/2025 by TN United Kingdom