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About the Role
The B100 Compliance Professional will manage projects affecting B100 Manufacturing in relation to compliance commitments and continuous improvement projects. This role will also act as a diversified technical person supporting B100 Manufacturing within Quality Systems for change control, CAPA closure, and event investigations.
Responsibilities
- Provide project management support on compliance related activities and continuous improvement projects specific to B100 Platforms or Bulk Manufacturing.
- Act as 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.
- Implement 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.
- Support Lead Investigator to collect data and investigate for deviations affecting the B100 platform.
- Collaborate transversally (QO, TS, MTECH, SME, QC etc.) to support the investigation.
- Identify and develop appropriate CAPA to address the root cause in collaboration with platform management and other stakeholders.
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.
- Must be legally entitled to work in Canada.
- North America Applicants Only
Skills
- SAP
- Phenix
- Qualipso
- Strong interpersonal skills
- Ability to lead projects
- Strong verbal and written communication skills
- Prepare timely Quality Metric reports
- Ability to work transversally across functions
- Ability to work transversally across functions/departments
- 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.)
Location
- Toronto Canada
Work Type
- Onsite
Experience Level
- 1-3 years of experience
Education Level
- Bachelor's degree
Salary/Compensations
- 69,200.00 - 110,000.00 (Includes target bonus)
Benefits
- Employees may be eligible to participate in Company employee benefits programs
About the Company
- 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.
- Pursue progress, discover extraordinary
- Better is out there. Better medications, better outcomes, better science.
- Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
- At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
- Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Equal Opportunity
- 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.
- At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.