Compliance Lead

Reference Number:R2853280

Position title:Compliance Lead

Department:Quality & Operations

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. 

Our Team/ Overview:

The Compliance Lead is part of Country Quality Operations within MCCQ. The Compliance Lead oversees Country Quality compliance programs, self inspection, quality risk management and establishment license (DEL and MDEL) management in alignment with Canadian GMP regulations, as well as Corporate requirements.

About Sanofi 

We’rean 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:

• Developing, implementing, and maintaining an effective compliance program.

• Ensuring that the site complies with all laws, regulations, and standards applicable in the pharmaceutical industry for licensed activities related to API (importation only) and Finished Goods (importation and distribution)

• Establishing and maintaining effective relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and representing the company in compliance-related matters.

• Maintaining a system to ensure compliance, regulatory and quality risks are properly identified, tracked, and mitigated.

• Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance.

• Ensuring that any compliance issues or drug shortage issues, are reported to the relevant authorities in a timely manner and coordinating with multiple stakeholders to ensure timely responses to any related inquiries.

• Managing and resolving any compliance issues or allegations that arise, and taking appropriate corrective and preventive actions.

• Establishing and monitoring key performance indicators (KPIs) and metrics for site compliance and regulatory and reporting on the results to management.

• Responsible for driving risk management, self inspection, and quality alert management

• Identifying and driving continuous improvement initiatives and projects to enhance compliance and effectiveness, fostering a culture of compliance.

• Defining the potential regulatory and license impact of changes made to the site products and services.

• Ensuring compliance of imported products and medical devices with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates; decide and execute the regulatory compliance maintenance program for the site products.

• Develop and lead inspection management team to ensure operational effectiveness and compliance.

• Oversee the tracking, requesting, compilation and compliance status of GMP evidence from all foreign contractors to allow importation/distribution of products into Canada via valid Establishment License

• Responsible for maintaining the Canadian Drug Establishment License (DEL) and Medical Device Establishment License (MDEL)

• Manage Vendor qualifications including Audits and Quality Agreements with suppliers and/or clients, and ensure that commitments outlined therein are complied with

• Participate actively in new product launch and special project strategies, support marketing and business development groups

• Manage label changes and ensure labelling is compliant with Health Canada regulations.

• Medical Information Quality Support: Oversee Quality questions from Med Info department and participate in cross-functional teams to address complex patient and HCP inquiries

• Serve in a backup capacity to the Country Quality Head and the other Quality Leads for their respective responsibilities

• Manage QA staff and external consultants, as required

• Lead inspection readiness and inspection management activities

Key Roles:

• Define initiatives to improve the compliance and effectiveness of our processes and systems

• Assess acceptability of various strategies for imported products in view of complex Health Canada regulations for imported products

• Proactively implement remediation action(s) from findings from internal and external GMP audit-/inspection-related topics and regulatory issues

• Support senior management on compliance topics. Define and execute inspection readiness plan.

• Coordinate quality alert and batch recall process with global team.

• Decide for which changes a regulatory strategy must be established and provide the strategy

• Develop remediation strategies for regulator and global Quality audit findings

• Consult on product disposition decisions for Quality and Compliance issues

• Define Strategy for communicating and responding to regulators on Quality and Compliance issues

• Inform senior management on the action plan to mitigate regulatory issues

• Other duties as assigned

About You

Education and Language:

• Must hold a university degree; this must be a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.

• English: Excellent knowledge (reading, writing and oral)

• French:  Considered an asset

Experience:

• 10-15 years in pharmaceutical industry (QA, QC, Production or equivalent)

• Minimum 7 years hands-on experience with imported pharmaceutical products and Health Canada regulations

• Strong understanding of Canadian GMPs related to Importation and Distribution

• Demonstrated experience managing establishment licenses (DEL and MDEL)

• Experience managing cross-functional teams and external consultants

• Proven track record in inspection management and regulatory authority interactions

• Background in risk management and compliance program development

• Strong management and leadership skills with demonstrated history