Skills Alliance Enterprise
Senior Manager, QC Operations
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Senior Manager, QC Operations
12-month contract
Stevenage, UK
£33/hr - Inside IR35
Rotating Shift Pattern:
- Sunday-Wednesday
- 2 weeks on 6am-3:45pm then 2 weeks on 12:15pm-10:00pm
About our Client:
Our client is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defense mechanisms, and eliminate these cells. They have a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumours, and autoimmune diseases.
Role Summary:
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.
The Senior QC Manager (Operations) leads a team of QC scientists covering a Sunday-Wednesday shift. The Senior QC Manager 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 Senior Manager monitors, maintains, and improves compliance within the team and across the department. QC Senior Manager interacts with multiple functions within the business to guarantee smooth and concise information exchange. Senior QC Manager (Operations) acts as function lead and is responsible for efficient provision of QC services to production and other internal and external customers by establishing strong leadership, developing, and implementing lean processes and assuring adherence to procedures.
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Key Responsibilities:
- Ensuring adherence to health and safety policies and procedures within the team
- Establishing SMART objectives for the team members and continuous progress monitoring
- Overseeing the batch certification process
- Managing QC schedule (creation, adherence) to ensure timely delivery of results to production and allow timely batch certifications
- Ensuring seamless cooperation within QC Operations across all shifts
- Ensuring efficient cooperation between QC operations and QC Microbiology, Regulatory CMC, QA, and QP.
- Managing workload and capacity for the team and assigning adequate priorities
- Managing and championing continuous improvement projects
- Managing the batch certification process (e.g., data review, approval, quality events)
- Overseeing of self-inspection initiatives
- Developing, reporting, and overview of QC operations metrics
- Looking after the wellbeing of the team
- Maintaining the QC laboratory in inspection ready state
- Overseeing implementation of new analytical procedures
- Ensuring adequate level of analytical competencies within the QC operations
- Representing the QC operations during internal and external audits
- 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
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Demonstrated Skills and Competencies
E – Essential P – Preferred
Experience:
- BSc/MSc degree in life sciences (P) or significant relevant industry experience
Qualifications:
- BSc/MSc degree in life sciences (P) or significant relevant industry experience
Skills/Specialist Knowledge:
- Attention to detail (E)
- Meet requirements to work in cleanroom environment (P)
- Excellent spoken and written communication (E)
- Influencing skills (E)
- Excellent time management (E)
- Ability to precisely follow procedures (E)
- Conflict resolution skills (E)
- Ability to organize complex testing campaigns (E)
- Experience in working in adherence to GMP regulations relevant to Quality Control function (E)
- Familiarity with analytical procedure lifecycle (validation, tech transfer, verification) (E)
- Familiarity with regulations governing stability testing and shelf-life management (E)
- Familiarity with analytical equipment qualification lifecycle (E)
- Experience with QMS quality events (application, conduct, timely closure) (E)
- Experience in modelling and forecasting capacity (P)
- 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 (E)
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