Deputy Director, QC Bioresources
Location: Sanofi Pasteur Limited / North York, Ontario
Reporting To: Director, Quality Control
Required Education: PhD in Immunology
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. For over 100 years, we’ve provided life-saving vaccines for the prevention and treatment of infectious diseases.
Sanofi Pasteur Limited, located in Toronto, is one of the company's four major R&D and manufacturing sites. We are home to Sanofi Pasteur's North American centre for Analytical and Bioprocess R&D. As well, we are the largest Canadian vaccine producer: each year, we manufacture 50 million doses of vaccine and distribute them to more than 90 countries around the world, helping to protect against 20 infectious diseases. This variety of activities offers employees diverse opportunities for personal and professional growth. Our company attracts some of the best minds in the business from across the globe. Our 1,300 employees give us their best and we offer the best in return.
Sanofi Pasteur Limited is looking for motivated and results driven individuals to join our Site Quality Operations Department as a Deputy Director, QC 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, 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.
- GMP Testing (25%)
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.
- Technical excellence/expertise (15%)
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.
- Compliance (15%)
Ensures all testing procedures and processes comply with organizational policies, and regulatory 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 and cGMPs. Ensure test changes are fully assessed according to site Change Control and act as sponsor to approve Change Control Requests (CCRs).
- Personnel Management (25%)
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 & Experience:
- PhD in Immunology or equivalent job experience with 5-8 years of experience in a high-volume laboratory setting, preferably a quality setting in a manufacturing environment.
- Firm knowledge of analytical testing including in vivo potency and safety analytical methods.
- Sound knowledge of cGMPs and pharmacopeial testing for US, Canada, Europe and Japan. Excellent report writing and communication skills.
- Previous experience in a supervisory/managerial position required (minimum of 3 years).
Hours of Work:
Monday to Friday: 8:00 – 4:00 p.m.
Qualified candidates may submit their resume with cover letter online via www.sanofipasteur.ca quoting *75133060-1
Applications received after the official close date will be reviewed on an individual basis.
Once selected for an interview, internal employees are required to notify their manager.
Sanofi in Canada embraces diversity in the workplace and is committed to achieving employment equity. 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 applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
We are an equal opportunity employer.
Company Name: Sanofi Pasteur Limited / North York, Ontario
Active from 3/20/2017 to 1/1/0001
CALAS/ACSAL National Office: PO Box 20507 - 2901 Sheppard Avenue East Toronto, ON M1T 3V5Tel.:416-593-0268 | Fax: 416-979-1819 | Email: firstname.lastname@example.org