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Deputy Director Site Data Integrity Lead and Validation - Vaccine

date publiée 02/23/2021
type de contrat Full time
reférence de l’emploi R2585609
location Toronto, Canada

Reference No. R2585609

Position Title: Deputy Director  Site Data Integrity Lead and Validation - Vaccine

Department: Validation Systems

Hours of Work: Monday to Friday: 8:00 – 4:00 p.m.

Location: Sanofi Pasteur Limited, Toronto, Ontario

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.

Summary of Purpose:

The Deputy Director role provides independent oversight to the data integrity program for the operations including data generation and Quality oversight of Validation activities linked to facilities, utilities and sterilization.  This individual will work in a detail oriented, compliant manner to ensure the operations align with sanofi pasteur policies, procedures, cGMPs and industry data integrity and equipment validation expectations.

Key Accountabilities:

  • Provide oversight for the governance, management and coordination of activities related to the GxP Data Integrity that includes directing, developing, and maintaining Data Integrity Compliance activities linked to manufacturing and applicable support processes.

  • Establish a firm understanding of Industrial Operations manufacturing systems and propose changes linked to Data Integrity, and recommends infrastructure changes to enhance Data Integrity.

  • Identify and leverage opportunities to continually improve the quality of data management systems, processes and standards.  Assure all systems, processes and outcomes comply with standards that meet applicable international and national regulations and guidelines.

  • The incumbent will be responsible for defining site validation plan and data Integrity plans in conjunction with site stakeholders.

  • Review and approve protocols required to complete equipment validation for new and existing equipment and utilities used in GMP areas (i.e. Installation, Operational and Performance Qualification (IQ/OQ/PQ including sterilization).

  • Support departments action plans around validation planning execution, performance indicator reporting including data integrity concepts and training.

  • Provide expertise and support to regulatory inspections including quality representation on all activities / topics involving Quality Operations linked to the manufacturing.

  • Management of staff responsible for support to identified data integrity and Quality validation oversight including staff development.

Key Requirements:

Education & Experience:

  • A degree in Engineering / Science combined with 7 to 10 years of relevant working experience within the biopharmaceutical industry in the area of Computer Systems Validation and Data Management

Required Qualifications:

  • Working knowledge of Production shop floor systems and processes

  • In-depth knowledge of the principle discipline- validation and biopharmaceutical industry compliance and data integrity assurance (i.e. cGXPs, 21 CFR Part 11 & EU Annex 11, current industry standards and practices, and process/environmental engineering)

Additional Preferred Qualifications:

  • Working knowledge and hands-on experience with production processing including automation, scientific writing, effective oral and written communication skills, and innovative thinking

  • Strong communication and influencing skills, problem solving, regulatory and compliance trends, strong leadership and management capability

  • Ability to anticipate evolutions due to internal and external factors

  • Ability to challenge status quo

  • Conflict resolution and problem solving

  • Planning and organizational skills

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

#GD-SP #LI-SP

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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