Compliance Professional

About the job

The B100 Compliance Professional will manage projects affecting the B100 Manufacturing in relation to compliance commitments and continuous improvement projects. This role will also act as a diversified technical person who works within the Quality Systems to support B100 Manufacturing in the context of change control lead/ super user, CAPA closure, and support with event investigations.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

1.     Quality/ Project Management Support (40%):

• Provide project management support on compliance related activities and continuous improvement projects specific to B100 Platforms or Bulk Manufacturing, with the aim to close gaps within the required timeframe and ensure uninterrupted production activities

• B100 Bulk representative for Site Wide Initiatives projects related to Quality Systems, Processes and Procedures

• Perform and/or participate in GQD gap analysis for the B100 Bulk Manufacturing Department

• Implements Corrective and Preventative Actions established as B100 commitments in response to Internal/ Global or Regulatory Audits

• Identify opportunities for alignment across the B100 platform applying LEAN methodologies

• Facilitate and lead compliance meetings, as required                                                                        

2.     Change Control and CAPA Lead / Super User (30%):

• Initiate and manage change control requests affecting the Bulk Manufacturing department

• Collaborate with assessors for evaluation of changes

• Ensure timely closure of change controls          

• Support Lead Investigators and B100 Platform in establishing change controls and/or CAPAs approved for execution in a very short timeframe to support closure of Deviations

3.     Technical Writing and Reviewer (20%):

• Update, review, and approve GMP documents such as SOPs, SWIs, protocols, reports

• Coach and oversee technical writing as needed

• Prepare and present Metrics reports for the B100 Platform

4.     Lead Investigator Support (10%):

• Lead Investigator support to collect data and investigate for deviations affecting the B100 platform

• Collaborate transversally (QO, TS, MTECH, SME, QC etc.) to support the investigation

• In collaboration with platform management and other stakeholders, identify and develop appropriate CAPA to address the root cause

Scope and dimensions:

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

• Site

Key dimensions:

• Project management within the B100 Bulk Manufacturing as required, in Toronto Canada.

• Diversified technical person who works within the Quality Systems to support the B100 Platform in the context of change control lead/ super user, CAPA closure, and support with event investigations.

• Document Reviews:  Logbooks, SOPs/SWIs, mBPRs

Freedom to act, level of autonomy:

• Responsible for the interpretation of cGMPs and industry guidance to achieve the required compliance levels. Makes decisions on the initiation, execution, and implementation of continuous improvement projects.

About You

Education and Experience:

• Minimum bachelor’s degree with 1-3 years of experience.

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

Key Technical Competencies and Soft Skills:

• Efficiently use company tools such as SAP, Phenix, Qualipso, etc. and the ability to adapt to new tools

• Strong interpersonal skills

• Ability to lead projects

• Strong verbal and written communication skills.

• Prepare timely Quality Metric reports.

• Strong verbal and written communication skills.

• Previous pharmaceutical and/or laboratory experience is preferred.

• Must be legally entitled to work in Canada.

• Ability to work transversally across functions.

• Ability to work transversally across functions/departments and strong teamwork within the HSE team.

• Strong attention to detail and analytical skills.

• Excellent communication and interpersonal skills.

• Technical writing, Presentation.

• Computer skills (Word, Excel, Access, PowerPoint etc.).

This position is for a new vacant role that we are actively hiring for.​ 

"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,  Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint. 

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.