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Manager, Quality Assurance and Regulatory Compliance
4 months ago
At Botanic Tonics, we know our world is fast, noisy and distracting. It can easily leave us feeling tied up, strung out and not ourselves. Maybe you think the more supercharged you are, the better you'll be. Maybe escape is the only way for you to truly feel free. We're not judging - we just have a different point of view. Because we're not a fuel for keeping pace with the rat-race of every day. We're not an elixir that transports you through the clouds to a tranquil place. We're kava products with blends of other naturally active ingredients, designed to bring you down to earth and into the present, so you can make the most of every moment.
Why waste effort trying to quiet the noise when you can tune into it, to hear the one voice that matters? We believe choosing to engage with the here and now is more fulfilling. It makes us feel good, enriches our lives, and brings out our best selves.
Be Present. Be You. When you can truly be there, you feel free.
As the Manager of Quality Assurance and Regulatory Compliance, you will play a key role in upholding our company's commitment to producing safe, effective, and compliant dietary supplements. You will oversee all aspects of quality assurance, regulatory compliance, and product safety, ensuring that our products meet or exceed industry standards and regulatory requirements.
Responsibilities
Quality Assurance Management
- Develop, implement, and maintain comprehensive quality assurance programs to ensure the safety, purity, and efficacy of all dietary supplement products.
- Establish and enforce quality control standards and procedures throughout the manufacturing process, from raw material sourcing to finished product distribution.
- Conduct regular audits and inspections of manufacturing facilities, suppliers, and contract manufacturers to ensure compliance with company standards and regulatory requirements.
- Investigate and resolve quality-related issues, deviations, and complaints in a timely manner, implementing corrective and preventive actions as necessary.
- Establish and maintain accurate and up-to-date documentation, records, and SOPs related to quality assurance, regulatory compliance, and product safety.
- Ensure that all required documentation, including batch records, testing reports, and certificates of analysis, are properly maintained and accessible for review.
- Stay abreast of current regulations, guidelines, and industry trends related to dietary supplements, including but not limited to FDA regulations, DSHEA, cGMPs, and other applicable standards.
- Interpret and apply regulatory requirements to product development, labeling, advertising, and marketing activities, ensuring compliance with all relevant laws and regulations.
- Prepare and submit regulatory filings, notifications, and documentation to regulatory agencies as required.
- Serve as the primary point of contact for regulatory agencies, auditors, and third-party certification bodies during inspections and audits.
- Evaluate and qualify suppliers and vendors based on their ability to meet quality, safety, and regulatory requirements.
- Conduct supplier audits and assessments to ensure compliance with company standards and regulatory expectations.
- Establish and maintain strong relationships with suppliers and vendors to facilitate communication and collaboration on quality and regulatory matters.
- Provide training and guidance to staff members on quality assurance principles, regulatory requirements, and best practices.
- Foster a culture of quality and compliance throughout the organization by promoting awareness and accountability at all levels.
- Bachelor's degree in a relevant scientific discipline (e.g., chemistry, biology, food science, pharmacology) required; advanced degree preferred.
- Minimum of 5 years of experience in quality assurance and regulatory affairs within the food & beverage, dietary supplement, pharmaceutical, or related industry.
- Thorough understanding of FDA regulations, cGMPs, and other relevant standards for food & beverages and dietary supplements.
- Strong knowledge of quality systems, auditing techniques, and risk management principles.
- Excellent communication, interpersonal, and leadership skills.
- Detail-oriented with the ability to prioritize tasks and manage multiple projects simultaneously.
- Certification in quality management (e.g., ASQ Certified Quality Auditor) or regulatory affairs (e.g., RAPS Regulatory Affairs Certification) preferred.
