Supply Chain Compliance Specialist

As a global healthcare company, Fresenius Kabi is Committed to Life. The company's products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and presence in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

WHAT WE OFFER
Benefits
At Fresenius Kabi Canada we foster a collaborative environment where employees are encouraged to share ideas and contribute to meaningful work. We offer unique learning opportunities to grow and build your career. In addition, we value each and every contributor and offer various benefits and rewards (as applicable) including:

• Company paid health and dental benefits that start on your first day of employment
• Company matched RRSP program
• Generous vacation plan with one extra day accrual for each year of service
• Paid float days and paid sick days
• Employee assistance program
• Casual office dress code
• Employee recognition program
• Perkopolis & Goodlife Discounts
• Professional growth and development opportunities

We are currently seeking a full-time Supply Chain Compliance Specialist
to join our team
The pay range for this role is: $75,000 - $85,000
This position is an existing vacancy within the organization.
Main Responsibilities

• Works with the team to complete incident investigations, root cause analysis, and implement corrective actions (Internal and Supplier Corrective Actions) as they pertain to supply chain actions and activities.
• Supports completion of Transportation Lane Qualifications (GUI 0069 requirements) for defined transportation lanes, both existing and new per product launch plans.
• Serves as the supply chain compliance representative on gap assessments (against Global SOP's, Health Canada Guidance Documents, etc.) and other initiatives
• Audits processes and documentation to verify accuracy and compliance at critical process points
• Initiates and/or reviews deviation investigations to help define necessary corrective actions to ensure complete, thorough, accurate and timely evaluation of non-conformances and prevention of reoccurrence.
• Responsible for development and maintenance of compliance KPI's within the department.
• Represents SCM (Supply Chain Management) department at meetings related to compliance topics incident investigations, root cause analysis & corrective actions.
• Updates, reviews procedures and applicable documents as assigned.
• Assists with regulatory gap assessment and change controls on behalf of SCM.
• Ensures timely communication of complaints to the Quality department and Adverse Drug Reactions to the Vigilance department as per Standard Operating Procedures.

Qualifications

• Bachelor of Science Degree in the Life Sciences is preferred.
• 3-5 years of experience in a cGMP environment (Health Canada GUI-001, GUI-0069) is preferred.
• Ideal candidate has working knowledge of various QMS systems and supply chain processes.
• Working knowledge of SAP and Microsoft Office Suite .
• Prior pharmaceutical industry experience is mandatory.

MORE ABOUT US
As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients' nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company's I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually.

Inclusion and Equal Opportunity Employment
At Fresenius Kabi Canada, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work. We are taking actions to tackle issues of inequity and systemic bias to support our diverse talent, clients and communities. We are an equal opportunity employer.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, we are committed to providing accommodations and will work with candidates to meet their needs and provide an accessible candidate experience. If you are a person with a disability and require assistance during the application process, please let us know We welcome members of all backgrounds, experiences and perspectives to apply.

Artificial Intelligence (AI) Use In Recruitment
Fresenius Kabi uses AI-supported tools to help compare applicant résumés with job requirements and identify potential matches. These tools do not make hiring decisions. All candidate reviews, selections, and decisions are made by our recruitment team.