Location: Harwell, OX11 0GD
The Senior Manager, Quality Control is concerned with sampling, specifications and testing as well as the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out and that materials are not released for use, nor are products released for sale or supply until their quality has been judged satisfactory. The Senior Manager, Quality Control is not confined to laboratory operations but must be involved in all decisions which may concern the quality of the product.
The Senior Manager, Quality Control is an active member of the site management team with the QC supervisor, QC project leader, QC engineer and QC manager reporting to this function.
The Role (daily responsibilities)
Recruits, leads and develops the QC team
Maintains open and effective communication with all other departments
Lives the organization's values, and creates the QC department's vision and mission
Ensures that the required equipment is bought, is qualified and calibrated per the validation master plan.
Ensures that Production and QC premises are conformed to GMP requirements for clinical or commercial production.
Ensures that QC laboratories are correctly maintained and operational
Ensures that all necessary testing is carried out and the associated records evaluated;
Ensures GMP compliance and implementation of QMS, product quality and team are driven by patient safety
Preserves license to operate and ensures implementations of remarks from any audits
Prepares and participates in audits with authorities and customers
Develop a fit for purpose approach based on risk assessment for QMS appropriate to clinical phase project advancement (ph I, II, III) or to commercial
-Ensures continuous improvement with QA through GMP watchfulness
Develop the mindset of a continuous improvement culture
Identifies and leads continuous improvement projects
Implement pertinent tools of operational excellence “Lean culture”
Tracks and is responsible for the budget of the QC department
Ensures deviations from the budget are communicated to business
Ensures best productivity and cost control in any project based on continuous questioning of practices over time.
The Candidate (requirements)
Bioengineering degree or Master's degree in biology, pharmacy, chemistry, (or equivalent)
At least 15 years of experience in a cGMP biopharmaceutical environment, including at least 5 years of people management.
Minimum 10 years experience in Quality control of a pharmaceutical company
Team leader and excellent communicator, quality-minded and customer-oriented.
Familiar with Operational Excellence principles.
Confirmed experience in QC techniques (Environmental testing, sterility testing, LAL, mycoplasma, PCR, various potency testing, cell characterization testing, etc.)
Experience in QC equipment qualification.
Experience in analytical methods validation and statistics
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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