Job Description
Summary
As a Quality Assurance and Regulatory Affairs (Compliance) Manager you will lead our compliance efforts across regulatory submissions and quality systems at Lief Labs. The Compliance Manager ensures that all products meet regulatory requirements and GMP (Good Manufacturing Practice) standards, from development through distribution. The ideal candidate will have deep knowledge of FDA regulations (21 CFR Part 111), DSHEA, FTC, supplement industry standards, and quality management systems.
Responsibilities
- Ensure all products comply with FDA (21 CFR Part 111), DSHEA, FTC, and international regulations where applicable.
- Review and approve Product labeling, Supplement Facts panels, claims, and marketing materials for regulatory compliance.
- Maintain and update technical documentation including Product Dossiers, Master Files, and ingredient safety data.
- Liaise with regulatory agencies and manage submissions, responses, and audits.
- Assist in new product development by providing regulatory guidance throughout the formulation and commercialization process.
- Monitor and interpret food regulations, including those from regulatory bodies such as the FDA, USDA, , and other regulatory authorities, to ensure compliance in all aspects of food and dietary supplement production, labeling, and distribution. Communicate potential impact to relevant stakeholders (Internal & External).
- Ensure that products and processes meet all regulatory requirements related to food and dietary supplement safety, sanitation, ingredient specifications, allergen management, and labeling.
- Collaborate with cross-functional teams to ensure accurate and timely submissions of all regulatory documentation.
- Conduct internal audits and inspections to assess compliance with regulatory requirements. Recommend and Implement corrective actions as needed.
- Oversee client requests related to regulatory documentation, certifications, and submissions, including but not limited to Non-GMO, Organic, NSF, Halal, and Kosher and ensure regulatory team is meeting established timelines
- Stay up to date on regulatory trends and changes affecting dietary supplements in the U.S. and key international markets.
- Oversee the development, implementation and maintenance of the Quality Management System (QMS) in accordance with cGMP (21 CFR Part 111), Sanitation, HACCP and ISO standards.
- Manage quality audits (Internal, Regulatory Bodies, and Client), including planning, conducting, reporting, and follow-up of corrective actions.
- Develop and track KPI Metrics for Quality
- Develop and maintain Standard Operating Procedures (SOPs), Batch Production Records, Product Specifications, and other QA documentation.
- Investigate and resolve quality incidents, including non-conformances, deviations, CAPAs, and customer complaints.
- Coordinate responses to FDA inspections and inquiries and implement corrective actions as needed.
- Ensure quality oversight of Raw Material and Component suppliers, testing labs through vendor qualification and performance monitoring.
- Lead training initiatives for staff on GMP compliance and quality best practices.
- Ensure that appropriate quality control measures are in place throughout the production process, including raw material inspection, in-process checks, and finished product testing.
- Develop and implement programs to monitor and assess product quality, including complaint management, trend analysis, supplier quality management systems and customer feedback and services.
- Drive continuous improvement initiatives to enhance product quality, safety, and customer satisfaction.
- Additional duties as assigned.
Supervisory Responsibilities
Yes
Education
Minimum Qualifications
Bachelor’s degree in Life Sciences, Chemistry, Nutrition, food science, food technology, or a related field. A master’s degree is preferred.
Knowledge
- Extensive experience (5+ years) in compliance management within the dietary supplement and/or food industry, preferably in a managerial role.
- Thorough understanding of food safety regulations, quality standards, and labeling requirements.
- In-depth knowledge of FDA dietary supplement regulations, USDA, GMPs, DSHEA, FTC advertising guidelines, and global supplement standards.
- Experience with quality systems, audits, documentation control, and CAPA management.
- Strong organizational, analytical, and communication skills.
- Ability to manage multiple projects and lead cross-functional initiatives.
- Strong knowledge of quality management systems, including HACCP, GMP, and ISO standards.
- Excellent understanding of food and/or dietary supplement production processes, sanitation practices, and supply chain operations.
- Strong attention to detail.
Skills/ Abilities
- Problem Solving
- Planning & Organizing
- Verbal Communication
- Written Communication
- Relationship Management
- Time Management
- Ability to interact at all levels
- Ability to work as a team member
- Flexibility/ adaptability/ multi-tasking
Physical Demands
While performing the duties of this job, the employee may regularly require talking, hear and grasp items. This position is active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day.
Regularly exposed to moving mechanical parts, strong fumes, loud noises, and occasionally extreme temperatures.
The employee must frequently grasp, lift and/or move items 20 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Additional Information
The Salary Range for this position at Lief Labs is $90,000.00 – $120,000.00 annual (USD). Starting pay for the successful applicant depends on a variety of job-related factors, including but not limited to market demands, experience, training, skills, and education. The benefits available for this position include medical, dental, vision, 401(k) plan, life insurance coverage, wellness benefits, education reimbursement program, and PTO. This position is bonus eligible.