Biological Quality Control Manager (EuAfMe-MP20200501) Girona, Spain
This position reports to the Site Quality Control Manager and will serve as the most senior Biological Quality Control Leader for the Site including Bioanalysis and Microbiology. The Biological Quality Control Manager will have overall responsibility to manage and control all QC Bio activities in accordance with identified Global Zoetis Quality Systems and Standards as well as all relevant regulatory and legislative regulations across the lifecycle of the Site products related with the biological controls.
Direct and oversee analytical activities by providing a Fit for Purpose and Safe working environment in which all equipment and methods are in a validated state and compliant with applicable regulations. Management of the Lab operations includes: Testing Management of Site Materials; Raw Materials, In process and Finished Product Samples; Stability Testing; Environmental Monitoring; Utilities; and Microbial testing.
Develop, Maintain, and Communicate Key Performance Metrics. Continuous Improvement is facilitated by use of metrics and process mapping to identify initiatives to enhance Lab performance. Ensure that the Analytical group operates in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practices. The Manager will oversee the groups’ training plans and training completion.
Participate as aseptic matter expert (SME) and Oversee the aseptic program for the site including i.e. media fills, aseptic training and qualification, etc.
Leadership Development and Coaching of QC lab Staff.
1) Manage the day to day operations of the Biological Quality Control laboratories including but not limited to: providing a safe, secure and efficient working environment; ensure all QC equipment is validated and safely operated; all assets are maintained, stored and organized to allow efficient and effective operation.
2) Maintain the Lab in a state of Fit for Purpose that includes both Regulatory Compliance as well as functionality (equipment calibration & qualification, QC IT tool & automation system validation).
3) Oversee Key Lab functions that include: Testing Management of site materials; semi finish and finish products; Stability Testing; Environmental Monitoring; Utilities and link with the Animal Welfare Department. And Ensure that analytical methods are adequately developed, validated, transferred and maintained.
4) Develop; Maintain; and Communicate Lab Key Performance Metrics (KPIs). Establish and maintain the Lab Capacity Utilization model and identify areas for continuous improvement to improve productivity. Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean Lab methodology.
5) Approve documents related to biological methods.
6) Immediate notification to the Quality Control Manager of any Quality Control issues and provide accurate and relevant information as required by the business. Ensure that adequate and timely analytical support for investigations and troubleshooting is provided, where needed to minimize impact on product availability and sales. Report all OOS/OOT/OOE for timely investigation. On the other side, de-escalate the information from the SLT/ QC Manager to all colleagues.
7) Assist the Site Quality department, as the main auditee for the Quality Control Laboratory, with preparation, management and follow up of internal audits and Health Authority inspections, as needed.
8) Support the development of quality goals and targets as part of the organization’s strategic plan.
Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 65 years of experience in animal health, Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2018, the company generated annual revenue of $5.8 billion with approximately 10,000 employees. For more information, visit www.zoetis.com.
Direct and oversee analytical activities by providing a Fit for Purpose and Safe working environment in which all equipment and methods are in a validated state and compliant with applicable regulations. Management of the Lab operations includes: Testing Management of Site Materials; Raw Materials, In process and Finished Product Samples; Stability Testing; Environmental Monitoring; Utilities; and Microbial testing.
Develop, Maintain, and Communicate Key Performance Metrics. Continuous Improvement is facilitated by use of metrics and process mapping to identify initiatives to enhance Lab performance. Ensure that the Analytical group operates in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practices. The Manager will oversee the groups’ training plans and training completion.
Participate as aseptic matter expert (SME) and Oversee the aseptic program for the site including i.e. media fills, aseptic training and qualification, etc.
Leadership Development and Coaching of QC lab Staff.
1) Manage the day to day operations of the Biological Quality Control laboratories including but not limited to: providing a safe, secure and efficient working environment; ensure all QC equipment is validated and safely operated; all assets are maintained, stored and organized to allow efficient and effective operation.
2) Maintain the Lab in a state of Fit for Purpose that includes both Regulatory Compliance as well as functionality (equipment calibration & qualification, QC IT tool & automation system validation).
3) Oversee Key Lab functions that include: Testing Management of site materials; semi finish and finish products; Stability Testing; Environmental Monitoring; Utilities and link with the Animal Welfare Department. And Ensure that analytical methods are adequately developed, validated, transferred and maintained.
4) Develop; Maintain; and Communicate Lab Key Performance Metrics (KPIs). Establish and maintain the Lab Capacity Utilization model and identify areas for continuous improvement to improve productivity. Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean Lab methodology.
5) Approve documents related to biological methods.
6) Immediate notification to the Quality Control Manager of any Quality Control issues and provide accurate and relevant information as required by the business. Ensure that adequate and timely analytical support for investigations and troubleshooting is provided, where needed to minimize impact on product availability and sales. Report all OOS/OOT/OOE for timely investigation. On the other side, de-escalate the information from the SLT/ QC Manager to all colleagues.
7) Assist the Site Quality department, as the main auditee for the Quality Control Laboratory, with preparation, management and follow up of internal audits and Health Authority inspections, as needed.
8) Support the development of quality goals and targets as part of the organization’s strategic plan.
Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 65 years of experience in animal health, Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2018, the company generated annual revenue of $5.8 billion with approximately 10,000 employees. For more information, visit www.zoetis.com.