Bulk Compliance Professional

Reference no. R2858765

Position title: Bulk Compliance Professional

Department: Production Strategy and Projects (DS)

Location: Toronto, ON

About the job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. 

The B100 Bulk Compliance Professional will manage projects affecting B100 Bulk 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 Bulk 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 the B100 Platforms with the aim to close gaps within the required timeframe and ensure uninterrupted production activities

• B100 Bulk representative for Site Wide Initiatives/ Continuous Improvement 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 FFaST meetings, as required                                                                        

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

• Initiate and manage change control requests affecting the B100 Bulk Manufacturing department

• Collaborate with assessors for evaluation of changes

• Ensure timely closure of change controls          

• Support Lead Investigators and the 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.     Compliance Manager Support (10%):

• Compliance Manager 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 B100 Bulk Manufacturing as required, in Toronto Canada.

• Diversified technical person who works within the Quality Systems to support 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:

Specific degree, duration of experience (Required to hold the job):

• Bachelor’s Degree in Sciences or Engineering

• 3-5 years of practical job experience supporting manufacturing, preferably pharmaceutical/biotech.

Key technical competencies and soft skills:

• Efficiently use company tools such as SAP, 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.

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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.

AI Usage

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.