Compliance Professional

Sanofi•Toronto, ON

2d•CA$69,200 - CA$110,000•Onsite

About The Position

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.

Requirements

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.
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.
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.).

Nice To Haves

Previous pharmaceutical and/or laboratory experience is preferred.

Responsibilities

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
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
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
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