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A Range of Possibilities

QC Laboratory Instruments and Systems Manager

date posted 11/25/2022
contract type Full time
job id R2669451
location Toronto, Canada

Reference No. R2669451

Position Title: QC Laboratory Instruments and Systems Manager

Department: QC Data Logistics & Support

Location: Sanofi Pasteur Limited, Toronto

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.

Position Summary:

This position is primarily responsible for the management of QC equipment and related business functional administrative activities for QC laboratory systems.  The incumbent will work closely with Quality Control, Quality Operations, Engineering Technical Services and Digital to ensure ongoing control and compliance of QC equipment and electronic systems and related data.  The incumbent combines an understanding of cGMP, equipment qualification, equipment decommissioning and lab electronic systems administration.  The Equipment Manager position reports directly to the Deputy Director of Laboratory Management / Data Logistics and Support (DLS).

Key Responsibilities:

Equipment qualification, decommissioning and support (65%)

  • Coordinates equipment qualification activities with QC labs and relevant supporting functions such as QOVS, QOOQ, ETS, Digital.

  • Ensure completion of necessary documentation/deliverables reflecting qualification of QC equipment.

  • Coordinates and leads execution of equipment decommissioning process for QC equipment.

Electronic System administration and support (10%)

  • Performs business administration relating to qualified QC electronic systems (master data configuration, user support requests) for systems such as Caducee/Empower, LabX, SoftMax Pro, MassHunter.

  • Performs business administration relating to electronic systems (SDMS).

Quality systems and documentation (10%)

  • Reviews existing SOPs and initiate revisions/approvals of existing or new SOPs, protocols, reports and test summaries as required.

  • Responsible for ensuring SOP accuracy and timely updates, cascades changes to all staff affected by initiating SOP reviews.

  • Manages activities related to Change Control and CAPA, as required.

Support responses to internal and external audits as required (10%)

  • Compile data to support regulatory submissions, audits, and root cause analysis as required.

  • Accountable to ensure the timely filing, and completion of all GxP documents associated.

Training/skills upgrade/literature review (5%)

  • Complete on-the-job training according to current lesson plan. Attend and participate in required training sessions continually.

  • Support and comply with all Sanofi Pasteur health, safety and environmental policies, contribute toward meeting departmental goals; and demonstrate progress in preventing or reducing injuries and/or illness.

Scope and dimensions:

  • Breadth of responsibility (global/regional/country/site): Site

  • Key dimensions: Key dimensions include shop floor quality/compliance adherence, management/scheduling of operational and project activities. This is a salaried position with no direct reports that will give guidance to both salaried and non-salaried personnel across the site.  The position liaises with QC Laboratory Management, SQO, ETS and Digital as required.

  • Freedom to act, level of autonomy: The incumbent interprets cGMPs and industry guidance and is responsible for making decisions to improve the quality and compliance status of QC equipment and associated data in context of equipment qualifications and operations.  He/she makes decisions on the initiation and implementation of continuous improvement projects.  Responsible for the interpretation of cGMPs and industry guidance to achieve the required compliance levels.

Key Requirements:

  • Preferred of bachelor’s degree in Science or Engineering

  • Require a minimum of 3-5 years of manufacturing industry experience (preferred industries in chemicals, pharmaceuticals, food, beverage, or oil/gas)

  • Strong technical background in manufacturing, process and specifications

  • Must be a self-starter, detail-oriented, effective independent contributor, and work well in team setting

  • Must be able to perform this job safely and comply with Standard Operating Procedures (SOP) and industry practices without endangering the health or safety of self or others

  • Strong attention to documentation practices

  • Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment

  • Consistently demonstrate Sanofi Play to Win behaviors; stretch, take action, act for patients and customers and think Sanofi first.

  • Familiar with Microsoft Office Suite (MS Project, Word, Excel, PowerPoint;  SAP, Phenix, GEODE+) knowledge an asset

  • A strong working knowledge of laboratory equipment and electronic systems, equipment lifecycle management, preferably in a GMP or otherwise regulated industry

  • Excellent verbal and written communication skills combined with a strong customer focus is required as well as an ability to deliver high quality work in defined timelines.

  • Knowledge in Project management principles including problem solving ability to lead and participate in teams is recommended

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

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.

#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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