Reference No. R2801222

Position Title: Manager, Site Metrology

Department: Centralized Maintenance

Location: Toronto, Ontario

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Directly manage and coordinate work with Lead Hand/team by assuring resources are planned and utilized efficiently and effectively to support R&D, QA/RA, Production and IO needs on Metrology activities across the Toronto plant. Manage the Metrology work team by developing plans for staff to maximize current and future capacity requirements and by providing ongoing leadership and performance feedback to the various Metrology staff within Sanofi Pasteur Limited Toronto. Maintain the Metrology/Calibration Program within the Facilities Management Division at a level that meets safety, regulatory compliance and/or applicable government guidelines and codes thus ensuring there is no loss of production or products. Assist in the development/implementation of key documents (Project Plans, SOPs, and Standards) by providing technical recommendations (risk/benefit).

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing Progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Responsible for the definition and application of site Metrology policy to be applied to GxP critical measuring devices (20 %)

• Participates in definition and development of Corporate Calibration Policy. Ensures site specific constraints are taken into consideration.

• Translates corporate policy into site policies and procedures and ensures their application. Presents and justifies impact of policy changes to Supply Chain Management Committee.

• Ensures that all key site personnel are appropriately trained and applying policies and procedures.

Develops and implements certification program for site (30 %)

• Establish frequency and tolerances to be applied for certification on GxP critical devices.

• Ensure compliance with cGMP guidelines and regulations with respect to certification programs.

• Ensures equipment is maintained in certified status. Any changes to equipment are reviewed and evaluated to ascertain whether additional studies, repairs and/or re-certifications are required.

• Ensure industry best practices are reflected in departments SOP's.

Writes and reviews SOPs, certification protocols and reports as required (20 %)

• Contributes to the writing of corporate policies for Metrology.

• Presents and justifies changes to site policies and procedures.

• Write and/or review standard operating procedures for equipment and procedures throughout the company with respect to metrology.

• Ensure that all departmental processes are covered by SOP's and are maintained as current.

• Provides expert review of OQ (Operating Qualifications) protocols and reports as required.

Maintains the competency of department (10 %)

• Ensures department has skills and competence required to carry out certifications.

• Trains technical and users on how to apply Metrology principles.

• Maintains self-up to date on industry best practices.

Provides expert assistance in selection of equipment/instrument or troubleshooting (10 %)

• Render expert assistance in troubleshooting certification and/or production failures linked to critical devices.

• Review equipment specification documents to ensure calibration constraints taken into consideration prior to purchase.

• Trains staff in root cause analysis as it pertains to critical devices.

Provides expert assistance in deviation and investigation (10 %)

• Support the leader of Investigation with deviations related to calibration.

• Write and/or review DCF

HSE Requirement/Statement:

Required language for all employees who have direct reports:

• Supervises and monitors compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures and regulations applicable to their work.

• Participates in the investigation of incidents and work-related illnesses.

• Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner.

• Takes every reasonable precaution to ensure the health and safety of staff.

• Ensures that protective equipment and clothing required is used by staff.

• Cooperates and assists the Joint Health and Safety Committee in carrying out its functions.

• Advises staff of any potential or actual health and safety hazard of which they are aware.

Required language if you do not have direct reports:

• Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

Dimensions/Scope:

• Responsible for Calibration of equipment and/or instruments at the Sanofi Pasteur Limited Toronto site.

Budgetary Responsibility:

• Manage an approved budget (>$500,000 and