Director of Quality Operations, Strategic Projects - Vaccines
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Title: Director of Quality Operations, Strategic Projects - Vaccines
Reference No: R2590283
Location: Toronto, Ontario
Sanofi Pasteur is the vaccines division of Sanofi and 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. And, at our Toronto Site we want the best and brightest minds to forge us forward and support our needs today – and tomorrow. Recently, we announced the largest investment in the history of life sciences in Canada to-date, to build a new vaccine manufacturing facility at the Sanofi Pasteur Toronto Site. With this investment Sanofi will continue to invest in research and development, maintain our strong footprint in biomanufacturing, and offer highly skilled jobs in Canada.
To help prepare for our future we are looking for a Director of Quality Operations, strategic Projects to join our team.
At Sanofi, we strive to foster a workplace where differences can thrive and be leveraged to empower the lives of patients.
We offer attractive compensation, benefits and rewards packages that will enrich your life today, and empower you to save, perform, grow and create your own life journey.
Join our team of more than 100,000 people in 100 countries who are transforming scientific innovation into healthcare solutions around the globe.
- You will onboard and lead a team ensuring the project program is aligned with regulatory, global and internal guidelines through the entire project life cycle from construction to registration and transitioning to commercial operations.
- You will provide guidance and technical support to the company for Quality related project planning; process, systems, method and computer validation; aseptic processes, shop floor operations, investigations, product assessment, audit and Quality Control test planning.
- You will build and manage a high performing multi-disciplinary team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments for the project life cycle from construction to registration.
- You will raise compliance and quality issues and solutions/proposals to senior management.
- You will develop, maintain and control departmental capital and operating expense budgets.
- You will provide expertise and support to regulatory inspections.
- You will ensure the project quality team objectives align with site objectives for safety, quality, productivity, cost, and continuous improvement.
- You will conduct regular performance appraisals and provide career development reviews and opportunities for the project quality team.
Your responsibilities to HSE
- You will be responsible to supervise and monitor compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures and regulations applicable to their work.
- You will participate in the investigation of incidents and work-related illnesses.
- You will respond promptly to all health and safety concerns or incidents and complete the appropriate documentation in a timely manner.
- You will cooperate and assists the Joint Health and Safety Committee in carrying out its functions.
Your attributes to success:
- Strategic Direction - Establishing direction, proposals, and alternatives to assure business viability through sustained compliance, efficient systems and quality culture in full collaboration with the project director.
- Collaborate with Site Quality Head to build adequate capabilities within the Quality organization for the project.
- Quality and Compliance - Leadership, design and implementation to improve Compliance and Quality Posture. This requires strategic planning/ vision as well as developmental and interpersonal skills.
- Minimum Bachelors Degree in science/engineering or a related field.
- 10-15 years of experience in an aseptic filling or sterile manufacturing in a pharmaceutical or vaccines environment.
- Candidate must possess superior organizational and leadership / teamwork abilities with direct experience in managing employees.
- In-depth knowledge of the biologic product license application process, and the associated regulatory requirements.
Key technical competencies and soft skills:
- This position must interact successfully with the fast-paced project team and have a good understanding of project management.
- Superior knowledge and understanding of quality, cGMPs, regulatory compliance intelligence, current quality and regulatory compliance trends.
- Strong problem solving and decision-making skills/tools to resolve issues in a manner that is customer focused; but without compromise to making good quality decisions.
- Ability to understand role's impact and influencing skills. Diverse business, quality, and industrial manufacturing knowledge base.
- Appropriate certifications and professional affiliations to ensure continuous learning and incorporation of c-GMPs
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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