Associate Director, Quality Control
Apply locations: Swindon, United Kingdom
Time type: Full time
Posted on: Posted Yesterday
Time left to apply: End Date: February 4, 2025 (4 days left to apply)
Job requisition id: 0086546
Catalent is currently recruiting for an Associate Director - Quality Control to join our busy Swindon site. The QC Associate Director is responsible for providing leadership and quality management support at Catalent’s Swindon site in the area of Quality Control.
This individual will have responsibility for Microbiology and Chemistry Quality Control aspects related to finished product testing and incoming material release. The individual will be expected to deputize for the Senior Quality Director as required.
The role:
Lead the Microbiology and Chemistry Quality Control teams to consistently and compliantly deliver against performance and financial targets driven by business need. Support the development, implementation and communication of a clear strategic vision for Quality to maximize employee focus and develop a competitive advantage. Ensure adherence to the standards of quality ruled by current cGMPs and the Company’s Quality Policies and site standard operating procedures. Maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems. Function as a Quality department liaison and subject matter expert to other department representatives. Maintain strong relationships with commercial customers, regulatory organizations and other industry contacts. Use quality/regulatory intelligence to redesign processes accordingly. Support the implementation of EH&S compliance within the QC function, in compliance with local laws and Catalent Policies. Ensure QC systems are compliant with corporate and site procedures as well as industry standards such as, but not limited to, testing, training and analytical equipment. Author/compile metrics for the QC function; present summary data to site management/customers on a regularly scheduled basis; participate in the site Quality Management Review. Facilitate investigations and root cause analyses in the laboratories and broader business. Recommend commercial operations priorities from trends in data analyses. Develop and/or administer and maintain the QC training program and enforce cGMP compliance. Manage, motivate and empower the team, communicating and implementing HR policies within the Department. Ensure effective communication and dissemination of site Quality goals and objectives. Host and participate in Regulatory Inspections and customer audits as required. Drive a culture of continuous improvement within the QC areas, implement best practices and deliver tangible performance improvements; propose, implement and enforce improvements. The Candidate:
Minimum BSc preferred in Chemistry, Pharmacy, or Biology with experience in pharmaceutical/GMP operations – essential. Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment is preferred. A strong background in continuous improvement; experience of ‘Lean Lab’ and certification as a Lean Six Sigma Green Belt (or above) is preferred. 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. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, confirming your request for an accommodation and including the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
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Lead the Microbiology and Chemistry Quality Control teams to consistently and compliantly deliver against performance and financial targets driven by business need. Support the development, implementation and communication of a clear strategic vision for Quality to maximize employee focus and develop a competitive advantage. Ensure adherence to the standards of quality ruled by current cGMPs and the Company’s Quality Policies and site standard operating procedures. Maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems. Function as a Quality department liaison and subject matter expert to other department representatives. Maintain strong relationships with commercial customers, regulatory organizations and other industry contacts. Use quality/regulatory intelligence to redesign processes accordingly. Support the implementation of EH&S compliance within the QC function, in compliance with local laws and Catalent Policies. Ensure QC systems are compliant with corporate and site procedures as well as industry standards such as, but not limited to, testing, training and analytical equipment. Author/compile metrics for the QC function; present summary data to site management/customers on a regularly scheduled basis; participate in the site Quality Management Review. Facilitate investigations and root cause analyses in the laboratories and broader business. Recommend commercial operations priorities from trends in data analyses. Develop and/or administer and maintain the QC training program and enforce cGMP compliance. Manage, motivate and empower the team, communicating and implementing HR policies within the Department. Ensure effective communication and dissemination of site Quality goals and objectives. Host and participate in Regulatory Inspections and customer audits as required. Drive a culture of continuous improvement within the QC areas, implement best practices and deliver tangible performance improvements; propose, implement and enforce improvements. The Candidate:
Minimum BSc preferred in Chemistry, Pharmacy, or Biology with experience in pharmaceutical/GMP operations – essential. Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment is preferred. A strong background in continuous improvement; experience of ‘Lean Lab’ and certification as a Lean Six Sigma Green Belt (or above) is preferred. 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. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, confirming your request for an accommodation and including the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
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