Department: B100 Bulk Production

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.

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.

The salary range for this position is:
69,200.00 - 110,000.00 (Includes target bonus)
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)LINKOR (US) LINK.

La fourchette salariale pour ce poste est la suivante:
69,200.00 - 110,000.00 (Comprend le bonus cible)
La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien