Senior Manager, Quality & Regulatory Affairs
J
JobgetherHealth and Wellness
Applicants considered across the United States and Ontario, CanadaFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 8+ years of experience
- Required Skills
- People ManagementQuality Assurance
Requirements
- 8+ years of experience in quality assurance and/or regulatory affairs within dietary supplements, natural health products, or a closely related industry.
- Strong working knowledge of FDA requirements, including 21 CFR Part 111 and DSHEA.
- Strong working knowledge of Health Canada Natural Health Product regulations.
- Demonstrated experience managing contract manufacturer quality within a brand-owner environment.
- Hands-on experience conducting contract manufacturing facility audits and driving corrective and preventive actions.
- Experience supporting adverse event reporting and related regulatory obligations.
- Previous people management experience with the ability to provide clear direction, coaching, and accountability.
- Bachelor's degree in food science, chemistry, biology, or another relevant scientific discipline.
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills.
- Willingness to travel periodically to manufacturing and supply partners as required.
Responsibilities
- Lead day-to-day quality and performance management for contract manufacturers and key suppliers.
- Develop and maintain quality agreements with contract manufacturing organizations and strategic suppliers.
- Lead contract manufacturer qualification and audit programs.
- Manage the third-party laboratory program, including laboratory qualification and testing oversight.
- Serve as the regulatory lead for US and Canadian compliance, including FDA and Health Canada regulations.
- Lead regulatory review and approval of product labels and marketing claims.
- Monitor regulatory developments and communicate risks and implications to leadership.
- Manage and develop the QA Manager, providing coaching and support.
- Partner with Innovation on quality and regulatory requirements for new product development.
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