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
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
