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Sanofi Group Manager, R&D Site Quality Operations in Toronto, Ontario
Title : Manager, R&D Site Quality Operations
Reference No. R2644940
Location : Toronto, Canada
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/MAJOR RESPONSIBILITIES
The purpose of this position is to manage the quality and compliance aspects and risks associated with test method qualification, validation and testing of clinical trial material (CTM) by Analytical Sciences (AnSci) in accordance with cGMP standards, and regulatory and internal requirements.
This purpose is achieved with focus on key NV project team representation for R&D Quality, quality audits (internal and external), investigations, and training.
Overall activities encompass providing technical expertise on all aspects of testing (both internally and outsourced) for AnSci locally, as well as participating on site and global quality improvement initiatives.
Documentation Review and Approval :
- Responsible for the review, assessment, and where applicable, the approval of original and revised procedures (e.g. relevant SOPs, directives, guidelines, policies), detailing all aspects of testing of clinical trial materials, equipment operations, and quality procedures for quality content and compliance to cGMPs.
Coordination of Failure Investigations and Assessment of CAPAs/Changes :
Responsible for coordinating the investigation and timely closure of deviations resulting from testing of clinical trial material. This includes recommendations for disposition based on assessment (root cause analysis) and follow-up for closure of corrective and preventative actions (CAPAs) initiated by the respective testing areas of AnSci, as well as the tracking, resolution and timely closure of change control requests that impact product and processes.
Quality metrics to be established, captured, assessed and reported in QA’s quality metrics program.
Performing Audits :
- Responsible for preparing, coordinating, performing, and facilitating audits of the various testing platforms/laboratories, and as required, of contract facilities to ensure compliance with cGMP standards and corporate policies. This includes the timely delivery of quality audit reports, assessment, follow-up and closure of audit observations, and communicating updates of the audit schedule to ensure changes are cascaded to all groups concerned.
Project Team Representation :
- Responsible for representing R&D QA on project team and/or sub-teams and/or working groups in order to provide direction on quality issues and regulatory compliance with respect to all aspects of testing. This includes liaising continuously with the R&D CMC Quality project team member, to ensure consistency in the quality objective approach and assisting in the project’s budgeting exercise for R&D Quality.
Collaboration on Local & Global Quality Initiatives :
- Participates in local and global R&D Quality initiatives impacting quality systems to ensure harmonization of processes. Works with global R&D QA colleagues on action plans for remediation and/or implementation.
Training and Interactions :
Responsible for training new and/or existing colleagues on specific procedures/processes when identified and/or designated by Department Head.
Responsible for communicating and collaborating on a timely basis with the respective project team representative +/or back-up to ensure continuous and consistent service.
CONTEXT OF THE JOB/MAJOR CHALLENGES
The incumbent is responsible for managing the quality and compliance risks associated with the testing of clinical trial material (CTM) in accordance with cGMP standards, and regulatory and internal requirements.
Familiarity with aseptic manufacturing processes, cleaning, sanitization, aseptic techniques, and aseptic process control, and all the relevant tests is fundamental in performing the job.
The incumbent will interact with other internal auditors, and other site auditors, and corporate (or third party) auditors during audits related to VCDS activities.
This position requires a strong understanding of quality, and team leadership attributes as the incumbent will lead a team of individuals/professionals from various VCDS and/or QO departments to resolve problems or implement quality systems. An ability to negotiate and communicate with people in a positive manner while identifying, discussing and rectifying problems is a requirement of the position. The nature of these relationships includes the range from senior management staff to direct line employees.
A fundamental understanding of manufacturing processes, test methods and development products is necessary for auditing, identifying and investigating deviations to standards, and specifications for deficiencies in processes. Investigations involve root cause analyses that lead to implementation of corrective and preventative actions (CAPA) that restore the compliance status of the errant process.
The ability to facilitate and prioritize the issues identified with the testing of CTM in a timely fashion requires flexibility, constructive and/or innovative thinking to resolve and manage the process.
Decisions the incumbent may make are based on multiple sources that will require further investigation or interpretation. Work consists primarily of duties requiring resolution through the choice of several learned policies and procedures with respect to analytical assessments, innovative approaches, and the like. The incumbent will be required to actively balance the quantity of their work with an acceptance level of quality while ensuring compliance.
The position requires that the incumbent interact with AnSci colleagues with a mandate to support the entire testing group as a representative of QA both within Project Teams, and on a consultant/expert basis.
The position generally operates both in an office and manufacturing/testing-type setting. The office environment requires intense concentration and visual examination of documents.
The position may require a particular vaccination for the areas of responsibility.
The position may require a minimal amount of travel.
The number of non-conformance investigations performed annually is dependent on the volume of activity within AnSci. The incumbent will be expected to manage the investigation of each in collaboration with the responsible department to ensure timely closure within defined limits.
The number of change control requests processed annually is dependent on the volume of activity within AnSci. The incumbent will be expected to manage the categorization, planning, verification and approval of each in collaboration with the responsible department to ensure timely closure.
The number of documents (e.g. SOPs) reviewed and approved annually is dependent on the volume of activity within AnSci. The incumbent will be expected to evaluate the compliance of each document to established standards, guidelines, and regulatory and internal requirements to approve the documents.
The number of CAPA projects processed annually is dependent on the volume of activity within AnSci.
(Minimum) Bachelor of Science Degree, specializing in Microbiology, Biochemistry, Immunology or related disciplines
(Preferred) Master of Science Degree, specializing in Microbiology, Biochemistry, Immunology or related disciplines
6-10 years related pharma experience in a Quality Compliant laboratory environment (SQO, QA)
Proven direct experience in Testing and Quality environments (processes and systems)
Excellent understanding of quality and compliance requirements of testing laboratories for Pre-Clinical to Phase III materials
Excellent knowledge of the GMPs for US, Canada and Europe and GLPs
Excellent report writing and oral communication skills
Working knowledge of Word, Excel, Powerpoint, Outlook, Visio and laboratory information management systems
ASQ Certified Auditor preferred
Quality System certification training from a recognized institution are all assets
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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.