Head of Site Quality Operations, Toronto IA
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This position guarantees the quality and regulatory compliance of products developed, manufactured and distributed by the site in accordance with Regulatory requirements and Global Quality policies and standards. This includes providing Quality leadership across the site organization as well as contributing to the development of quality policies throughout Sanofi Pasteur. These quality policies include establishing and monitoring effective compliance programs in the GMP areas as well as other quality and compliance programs influencing the business and strategic operations. The position is also a key leader in Sanofi Pasteur global policy, direction, and strategy. This position maintains reporting to the Sanofi Pasteur Chief Quality Officer and the Toronto Site VP Industrial Affairs.
- To lead quality and compliance policy for continuous improvement that will balance business needs in order to assure affordable, safe, and effective products delivered on time
- Final decision on lot release
- Sustain business viability and create competitive advantage via quality and compliance
- Raise compliance and quality issues and solutions/ proposals to senior management. Develop, maintain and control departmental capital and operating expense budgets.
- Develop, review and implement Corporate Quality Policies. Leadership role in support of global and site initiatives
- Provide guidance and technical support to the company for project planning, process, aseptic processes, validation, component / product release, trending, deviation investigations, product assessment, disposition, complaint management, records retention, document distribution, and audits
- Supervise staff in accordance with company commitment and appropriate policies and procedures. Conduct regular performance appraisals and provide career development reviews and opportunities for staff.
- Highlight the most significant aspects of the environment that affects the job. Describe the most important problems to resolve to achieve the job’s major purpose.
- Establishing direction, proposals, alternatives to assure business viability through sustained compliance, efficient systems and quality culture
- Balancing and incorporating regulatory compliance and quality initiatives into the supply chain in a manner to provide more efficiency, increasing quality and compliance, and ensuring on-time Class A delivery.
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.
- Challenges range from organizational issues to resource utilization impacting supply and developmental activities that need it be balanced amongst all business needs
Scope and dimensions
- This position influences site executive management’s decisions, global supply chain, and corporate policy. As a member of Corporate Committees, influences corporate decisions.
- To access the state of controls, compliance, quality and efficiency on a constant basis and to facilitate improvement
- To design, provide, evaluate improvement initiatives for implementation in strategic plans.
- To determine the significance of deviations in a process, component or systems.
- To define policies and approach to strategic and tactical issues (e.g. validation master plan)
- To define quality systems adequate to sustain quality and compliance
- To establish departmental priorities and resource allocation.
- To develop any initiative to improve compliance and quality
- To act as the final lot release agent for the company
- Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.
Education and Experience
- Bachelor's Degree in Science required (Master's/Doctorate in Science preferred) with a minimum of 15 years experience in pharmaceutical or related industry with a concentration in Quality Operations.
- Background in manufacturing and development, Regulatory Affairs and/or Quality Control.
Key Technical Competencies and Soft Skills
- Must be able to work strategically in a fast paced environment and make balanced decisions related to quality.
- Must have the ability to communicate verbally and in written format effectively through multiple layers of the organization
- Experience interacting with regulatory agencies and health authority inspections is required
- Excellent organizational, interpersonal and leadership/teamwork abilities are required
- A strong customer focus and ability to prioritize and adapt to business and manufacturing needs are required
- Strong GMP background including working knowledge of GLP/GMP
- Strong management and supervisory skills
- Strong analytical and balanced decision making skills
- Ability to understand role's impact and influencing skills
- Diverse business, quality, and industrial manufacturing knowledge base
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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