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QA/RA Manager – Canada

New Chapter

This is a Full-time position in Toronto, ON posted September 15, 2021.

Recognized as a 2021 Best Places to Work in Vermont, New Chapter is a certified B-Corp, and an Organic, Non-GMO and certified Gluten Free manufacturer of dietary supplements that places our employees and our consumers first. We are a wholly owned subsidiary of Procter & Gamble. We invite you to discover a new chapter in your career, and in your life, by considering this opportunity to join our team! We strongly encourage applications from diverse communities across race, gender, sexual orientation, religion, ethnicity, national origin, and other marginalized communities.MAJOR ROLE ACCOUNTABILITIES:* Maintain Quality systems in accordance with the Canadian Quality of Natural Health Products (NHPs) Guide and Canada GMP Guidelines for NHPs. This includes ownership and maintenance of corresponding written Standard Operating Procedures (SOPs).* Responsible for Site License renewal /amendments for New Chapter Canada Inc.* Oversee Foreign Site Reference Numbers (FSRN) for NCI and all contract manufacturers.* Responsible for all aspects of Natural Health Product license applications and amendments utilizing external consultants as needed.* In collaboration with NCI, plan and execute regulatory deliverables, such as regulatory sheets and labeling reviews, involving cross-functional team members* Coordinate work with logistics partners in Canada (e.g., UPS) and ownership of work instructions with UPS.* Ensure that all outsourced activities meet GMP requirements.* Ensure that products are stored, distributed, and handled in such way that quality is maintained throughout the shelf life.* Work collaboratively with NCI to coordinate sampling, inspection and testing of products imported into Canada and ensure reserve samples and ongoing quality control documentation are appropriately maintained.* Maintain audit program and coordinate audits, as needed.* Design, develop and implement quality control training programs.* Monitor Natural Health Product Regulations.KEY COMPETENCIES:* Leadership* Technical Capacity* Discretion* Problem Solving/Analysis* Decision Making* Strong communication and collaboration skills* High attention to detailEXPERIENCE, EDUCATION and CREDENTIALS:* Bachelor’s degree in Chemistry, Biology, or other Life Science major.* 5+ years Canadian experience in GMP, Regulatory, NHP, and/or Food Manufacturing, in a Regulatory Affairs, Quality Assurance or Quality Control role.* Experience filing Canada Natural Health Product license applications and Canada site license applications and renewals.* Knowledge of Canadian regulations and Regulatory Body Inspections. General understanding of US FDA regulations.New Chapter is an equal opportunity employer. 

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