Deputy Director, QC BioResources
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Position Name: Deputy Director, QC BioResources
Site/Department:Toronto/Quality Control, BioResources
The Deputy Director of QC BioResources is responsible for all aspects of in-process and final product release testing, ensuring that testing process and procedures are compliant with local and global health, safety and regulatory standards. They will assure resources are planned and utilized effectively to support R&D and IA testing needs. They will be responsible for management of day-to-day operations of their area including personnel activities, technical oversight, animal care standards, testing workflow and capacity management and budget control. In addition, the individual will provide assistance to Industrial Affairs and Research and Development groups for investigations, trouble-shooting or risk assessments relevant to vaccine products, tests or testing equipment. As a member of the QC Management Team, provide leadership for change initiatives and help identify and implement continuous improvement opportunities.
Management of Operations (20%):
- Responsible for the management of the organization, planning and day-to-day activities of QC BioResources (Center of Excellence for in vivo tests), ensuring efficient and effective support for both in-process and finished product testing.
- Ensure department can deliver high quality testing services in a safe and compliant work environment, maintaining humane animal care and husbandry.
- Support the preparation of annual budgets, monitor spending and control costs by effective utilization of personnel and materials.
- Develop and implements plans for external testing or services as needed to achieve departmental deliverables.
- Ensure the accuracy and compliance of departmental test conduct, test results, and documentation practices.
- Provide analytical methods that are appropriate, and ensure that equipment used in the testing are properly calibrated and maintained, with accompanying documentation.
- Conduct scientifically sound investigations into atypical or out-of-specification laboratory data with an emphasis on finding and addressing root causes.
- Trend departmental data and provide input to Annual Product Review (APR) as requested.
- Compile, analyze and correlate technical data and write laboratory reports or protocols in support of continuous improvement projects, investigations, and regulatory agency updates or submissions.
- Interact with colleagues in local and global Industrial Affairs, Research and Development and Regulatory Affairs as SME to communicate technical information in a professional and timely manner.
- Establish and assess quality performance metrics for the laboratory and identify opportunities for improvements in quality, service, control and costs.
- Ensures all testing procedures and processes comply with organizational policies, and regulatory and animal care requirements. Participate in regulatory inspections and ensure responses and CAPA actions are completed by designated target date.
- Maintain working knowledge of regulatory requirements applicable to the industry.
- Perform review and approval of Standard Operating Procedures, Standard Work Instruction that detail the testing and maintenance of laboratory equipment and systems for technical content, and compliance with the pharmacopeia, cGMPs and standards of animal care.
- Ensure test changes are fully assessed according to site Change Control and act as sponsor to approve Change Control Requests (CCRs).
- Lead a team of 20-25 staff members and ensure that professional development and training are aligned with current and future needs.
- Ensure compliance of direct reports with GxP and other quality and documentation requirements, and ensure department training is up to date to perform the designated cGMP activities and requirements for Health and Safety.
- Coach and motivate staff to perform efficiently and achieve objectives on time, on budget.
- Oversee the recruitment, hiring and training of new staff to ensure the competency of QC Bioresources remains aligned to business needs.
Education and Experience:
- MSc preferred in Immunology, or Veterinarian preferred or equivalent job experience
- Min 5 (five) years of experience in a high-volume laboratory setting, preferably a quality setting in a manufacturing environment.
- Firm knowledge of analytical animal testing including in vivo potency and safety analytical methods.
- Sound knowledge of cGMPs, pharmacopeia/pharmacopeial testing and animal care standards.
- Excellent report writing and communication skills.
- Ability to communicate and work with a very broad spectrum of professional and lead technical staff to effectively manage in an efficient and practical manner.
- Flexibility to plan and work with rapidly changing business needs and ability to troubleshoot and resolve as a subject matter expert.
Sanofi Pasteur: The world’s leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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.
Sanofi, Empowering Life
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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