Senior Manager of Quality Control Operations

3 weeks ago


Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time
Job Summary

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



  • Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

    Job SummaryWe are seeking an experienced Senior Quality Control Specialist to join our Analytical Operations team at Autolus Limited. As a key member of the team, you will be responsible for ensuring the quality and integrity of our products throughout the entire manufacturing process.Key Responsibilities


  • Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

    Job Title: Senior Quality Control SpecialistAt Autolus Limited, we are seeking a highly skilled Senior Quality Control Specialist to join our team. As a key member of our Quality Control department, you will be responsible for ensuring the quality of our products and processes.Key Responsibilities:Execution of analytical tests - in process drug product...


  • Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

    Job SummaryThe Manager, Quality Control Operations will be responsible for managing and executing all routine testing using validated analytical methods and following prescribed testing plans. This role will oversee testing schedules, schedule adherence, and establish effective communication between all stakeholders. The successful candidate will monitor,...


  • Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

    Job Title: Senior QC Scientist, QC OperationsJob Summary:Autolus Limited seeks an experienced Senior Quality Control Scientist to join our Quality Control Operations team. The successful candidate will be responsible for managing and executing all routine testing using validated analytical methods and following prescribed testing plans.The Senior QC...


  • Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

    Job Description**Job Title:** Senior QC Scientist, QC Operations**Company:** Autolus LimitedJob SummaryAs a Senior QC Scientist in QC Operations, you will play a critical role in ensuring the quality and integrity of our products. You will be responsible for managing and executing all routine testing using validated analytical methods and following...


  • Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

    Quality Control Operations Manager - AnalyticalJob SummaryAutolus Limited seeks a highly skilled Quality Control Operations Manager - Analytical to lead and manage the execution of all routine testing using validated analytical methods following prescribed testing plans. The successful candidate will be responsible for monitoring and driving manufacturing...


  • Stevenage, Hertfordshire, United Kingdom HE Space Operations GmbH Full time

    Senior Digital Payload ManagerWe are seeking an experienced Senior Digital Payload Manager to join our team at HE Space Operations GmbH. This is a challenging role that requires strong leadership skills, technical expertise, and excellent communication abilities.About the RoleThis position involves overseeing end-to-end project management for digital payload...


  • Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

    Role SummaryAt Autolus Limited, we are seeking a Quality Control Specialist to oversee the routine inspection, sampling, and testing of all incoming materials for production use. This includes a wide variety of materials critical for the successful manufacture of our products and delivering safe treatments for patients.The Quality Control Specialist will...


  • Stevenage, Hertfordshire, United Kingdom East and North Herts NHS Trust Full time

    Job Summary:We are seeking a Quality Control Laboratory Assistant to join our team at East and North Hertfordshire NHS Trust. As a Quality Control Laboratory Assistant, you will play a crucial role in supporting various functions of our Quality Control laboratories.Main Responsibilities:You will be responsible for dealing with customers and health...


  • Stevenage, Hertfordshire, United Kingdom GSK Full time

    Job Details:The role of the Senior Quality Manager at GSK is a strategic and expert position that serves as the quality business partner for assigned R&D functions, programs, and/or Third Parties. This role provides expert quality information, manages identified issues, and supports continuous improvement particularly in scope of Health Care Technologies,...


  • Stevenage, Hertfordshire, United Kingdom GSK Full time

    About the RoleWe are seeking a Senior Manager to lead our Quality Management team. This is a critical role that requires a strong background in pharmaceutical quality and risk management.Lead Root Cause Analysis for cross-functional issues and any critical risk/issue via dedicated Root Cause InvestigatorCoordinate CAPA management and advise on CAPA...


  • Stevenage, Hertfordshire, United Kingdom MBDA Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Manager to join our team at MBDA. This is an excellent opportunity to leverage your expertise in quality assurance and contribute to the success of our projects.About the RoleThis role will involve providing quality assurance support to our projects, ensuring that they meet the required...


  • Stevenage, Hertfordshire, United Kingdom Electus Recruitment Solutions Full time

    Job Title: Senior Motor Control Systems EngineerJob Summary:We are seeking a Senior Motor Control Systems Engineer to lead the design, development, and validation of embedded control systems across a range of actuator products. The successful candidate will collaborate within a multi-disciplinary design team, owning the design, development, and proving of...


  • Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

    Job SummaryAt Autolus Limited, we are seeking a highly skilled Quality Control Specialist to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the quality and safety of our products.Key ResponsibilitiesConduct thorough inspections of incoming materials to ensure they meet our quality and safety...


  • Stevenage, Hertfordshire, United Kingdom Futures Full time £80,000 - £100,000

    £80,000 - £100,000 + BenefitsSite Based | Opportunities for travel/home working.Futures is thrilled to be partnering with the UK's premier designer, manufacturer, and installer of Window Displays, Retail Furniture, and Merchandising Décor as the business continues its global expansion from its base in Stevenage.With an exciting customer base that includes...


  • Stevenage, Hertfordshire, United Kingdom Morson Talent Full time

    Job Title: 2nd Shift Mechanical Inspector - Quality Control RoleAbout the Role:Morson Talent is seeking a skilled Mechanical Inspector to join our team on a 2nd shift basis. As a Mechanical Inspector, you will be responsible for ensuring the quality of products by examining them for correct assembly, finish, and physical damage.Key Responsibilities:Certify...


  • Stevenage, Hertfordshire, United Kingdom Mane Contract Services Full time £80,000

    Job Summary: We are seeking a highly skilled Senior Motor Controls Technologist to join our team at Mane Contract Services. As a technical leader, you will be responsible for providing guidance and support to the Motor Controls team, ensuring the delivery of high-quality project outcomes. Your expertise in designing and developing control algorithms for...


  • Stevenage, Hertfordshire, United Kingdom Mane Contract Services Full time

    Job Title: Senior Motor Controls TechnologistAbout the Role:We are seeking a highly skilled Senior Motor Controls Technologist to join our team at Mane Contract Services. As a technical leader, you will be responsible for providing guidance and support to the Motor Controls team, ensuring the delivery of high-quality project outcomes.Key...


  • Stevenage, Hertfordshire, United Kingdom Jas Gujral Full time

    Job Title: Senior Quality Assurance SpecialistEstimated Salary: £60,000 - £80,000 per annumCompany OverviewJas Gujral is a reputable organization dedicated to delivering high-quality products and services. As a leading industry player, we strive to maintain the highest standards in quality management.Job DescriptionWe are seeking a highly skilled Senior...


  • Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

    **Job Summary**The Autolus Limited team is seeking a highly skilled Senior Quality Assurance Specialist to join our Product Delivery Quality Assurance team. As a key member of our team, you will play a critical role in ensuring the delivery of autologous CAR T-cell products in compliance with Good Manufacturing Practice (GMP).Key Responsibilities:Maintain...