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Supervisor, Compliance

Jubilant DraxImage inc.

This is a Full-time position in Montreal, QC posted May 1, 2021.

Jubilant DraxImage, a subsidiary of Jubilant Pharma Holdings Inc, is currently recruiting for a Supervisor, Compliance position to join our growing team What can we offer?

A culture that values opportunity for professional growth and development,highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.

Jubilant DraxImage Inc.

is a rapiuly growing company with offices in Kirkland, QC and Yaruley, PA.

A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team.

Jubilant DraxImage is a proud member of the Jubilant Pharma family.

For more information, visit www.draximage.com We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.

If you’re up for a rewarding challenge, we invite you to take the first step and apply today Jubilant Pharma Holdings Inc and all our subsidiaries prouuly embraces diversity in our workforce.

Our goal is to have a workforce as diverse as the patients and clients we serve.

We have an inclusive environment where our employees can thrive and where our differences are welcomed.

By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.

Responsabilities Supervises and monitors the activities of Auditor, Investigation Specialist and Medical device Associate.

Administers the Quality programs such as but not limited to: Investigations and CAPAs, Complaints, Annual Product Quality Review, Supplier Qualification, Audits and Quality Agreements.

Ensures those programs and relevant documentation are maintained in compliance with all applicable regulatory standards and guidelines.

Resolves and documents problems and/or issues pertaining to the Quality issues and relevant processes.

Promptly raises major and critical Compliance and/or Product risks.

Support third-party or regulatory GMP inspections as well as Notified Body audits.

Acts as Primary Contact during Medical Device Inspections.

Tracks key performance indicators.

Provides periodic status to Management as requested.

Ensures accurate quality project schedules are maintained and communicated to both internal and external management.

Provide Quality Acumen to support department, teams and projects.

Recruits and train staff to carry out the Quality System activities and compliance oversight.

Periodically reviews the performance of the team with regards to the achievement of goals and key performance indicators.

Coach the team and ensure professional development of employees and knowledge redundancy among the Quality team.

Support maintaining certification program for medical device products (eg.

ISO 13485 / FDA CFR Part 820).

Performs aliitional duties as assigned by Management.

BS in Science or Engineering in a related field Five (5) to Seven (7) years of experience supporting Drug and/or Medical Device Quality Management System In-depth knowledge of GMP regulations for Canada, USA, Europe and compendia standards (USP, Ph.Eur.) as well as FDA 21 CFR 820 / ISO 13485.

Good Knowledge of ISO 14971 “Application of risk management to medical devices” Strong interpersonal and communication skills and solid report writing ability.

Computer literacy (Microsoft Office and SAP environment) Bilingual (French & English).

Proficiency in English is essential