Job description:
Reference No. R2679013
Department: Microbiology
Sanofi Vaccines
Sanofi’s global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.
At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
Position Summary:
The Technical Manager will support QC in approval and timely release of test results, and the associated activities related to control of documents and test performance monitoring. The Manager will have the responsibility to create and update protocols, reports and SOPs related to routine testing and projects. In addition, the role requires support of audits and new equipment/software upgrade and qualification.
Key Responsibilities:
Review/verification/approval of tests and organizing of the test related documentation, as required:
• Accountable for ensuring on time delivery of completed test documentation.
• Ensure accuracy and compliance with cGMP.
• Ensure documentation is expedited in a timely manner to facilitate the release of product to market.
• On a weekly basis monitor and track requirements for test approvals to ensure on time release of product.
• Responsible for ensuring monthly review of logbooks are completed.
• Responsible for accurately compiling data for tests, products, trending for statistical reports, to support regulatory questions and/or submissions as required.
• Perform LIMS queries as required (for trending or other purposes).
• Responsible for organizing and management of documents in accordance with department and corporate policies.
Quality systems and documentation:
• Reviews existing SOPs and initiate revisions/approvals of existing or new SOPs, protocols, reports and test summaries as required
• Responsible for ensuring SOP accuracy and timely updates, cascades changes to all staff affected by initiating SOP reviews.
• Manages activities related to Change Control and CAPA, as required
• Responsible for notifying Manager of any laboratory non conformances.
• Reviews and Approves LIR as required. Leads investigations and provides required support documentation to expedite closure of deviations.
Support responses to internal and external audits as required:
• Compile data to support regulatory submissions, audits, and root cause analysis as required.
• Accountable to ensure the timely filing, and completion of all GxP documents associated
• Support LIMS related test analysis updates.
Equipment certification, qualification, validation and other activities:
• Coordinating maintenance and re-certification/recalibration of equipment.
• Assists with equipment commissioning and decommissioning, qualification and validation.
• Following up on instrument alarms and printing charts, as required.
Other laboratory administrative duties:
• Placing orders with external or internal vendors
• Placing and following up on Facilities work orders in SAP
• Training/skills upgrade/literature review; complete all assigned training
• Support and comply with all Sanofi Pasteur health, safety and environmental policies, contribute toward meeting departmental goals; and demonstrate progress in preventing or reducing injuries and/or illness.
Scope and dimensions:
• Breadth of responsibility (global/regional/country/site): Local
• Key dimensions: headcount (direct and indirect) budget, doses, Capex… – Key indicators on which the job holder will be evaluated (WHAT in 9box):
• This is salaried staff position with no direct reports. The Technical Manager will be responsible for test approval for assigned tests, and to ensure timeliness of released results based on the supply requirements. This role requires oversight of the departmental quality systems and to manage documents related to qualification and validation projects. The Technical Manager is expected to provide guidance and training to technologists on equipment and software, as required. Responsible to lead and manage CAPAs and CCRs under scope of responsibility, to ensure regulatory, quality and HSE compliance.
Key Requirements:
• The minimum acceptable skills and knowledge required for a Technical Manager is a Bachelor of Science in Biological Science or related discipline, with +2 years previous relevant experience in Quality control and/or Pharmaceutical/Biotechnology laboratory setting or related experience.
• Sound knowledge and experience working in the field of Biological Sciences, Biochemistry or a related field.
• Excellent understanding of GMP requirements.
• Sound knowledge and experience with Immunological analytical methods including: ELISA, cell-based assays.
• Sound statistical knowledge.
• Strong written and oral communication skills.
• Strong analytical and balanced decision-making skills.
• Complete work in a timely, accurate manner with minimal supervision.
• Ability to work independently as well as part of a team. Organizational skills, flexibility and efficiency are essential.
• Stretch, Take action, Act for patients & customers, Think Sanofi first, Develop People, Make Decisions, Lead Teams.
Pursue Progress.
Discover Extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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