Regulatory Affairs Quality Assurance Compliance Manager (On-site)

Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house Product Development and R&D team create the best-tasting and most cutting-edge formulations of supplements. Lief also houses a state-of-the-art, full-service Current Good Manufacturing Practice (cGMP) manufacturing facility, which offers custom solutions for a multitude of supplement categories. Lief collaborates with entrepreneurial firms to help them build premier brands. Our turnkey solutions allow us to engage in seamless partnerships that help brands with scalability and sustainable growth. Lief Labs is located in the Santa Clarita Valley (Valencia, CA.) All roles are on-site Monday – Friday.

Summary

As a RA/QA Compliance Manager, you will be responsible for ensuring that the organization complies with all applicable regulatory requirements, industry standards, and internal policies related to food safety, quality, and labeling. Your primary objective will be to develop and implement compliance programs, policies, and procedures, conduct audits and inspections, and provide guidance and training to employees to ensure adherence to all relevant regulations. You will collaborate closely with cross-functional teams, including quality assurance, production, supply chain, scientific affairs, and regulatory, to maintain and enhance compliance across the organization.

Responsibilities

• Compliance Program Management:
• Develop, Implement and Maintain a comprehensive compliance program that covers all relevant food safety, dietary supplement, quality and labeling regulations, standards and guidelines.
• Stay updated on changes in regulations and industry best practices, ensuring that compliance programs are up-to-date and aligned with the latest requirements
• Establish policies, procedures, and control mechanisms to ensure consistent compliance with all applicable regulations and standards.
• Conduct regular risk assessments and gap analyses to identify areas of non-compliance, develop and implement action plans for improvement.
• Regulatory Compliance and Quality Management Systems (QMS):
• Monitor and interpret food regulations, including those from regulatory bodies such as the FDA, USDA, CFIA, and other local regulatory authorities, to ensure compliance in all aspects of food production, labeling, and distribution.
• Ensure that products and processes meet all regulatory requirements related to food safety, sanitation, ingredient specifications, allergen management, and labeling.
• Perform and oversee the timely completion of regulatory requests, including submissions of regulatory documentation, such as ingredient declarations, nutritional information, product certifications, and labeling claims.
• Conduct internal audits and inspections to identify areas for improvement and ensure ongoing compliance with quality standards, assess compliance with regulatory requirements and recommend corrective actions as needed.
• Liaise with regulatory authorities, auditors, and certification bodies to facilitate inspections, audits, and certifications.
• Coordinate and prepare for external audits and inspections, ensuring readiness and compliance with all requirements.
• Respond to audit findings, implement corrective actions, and monitor ongoing compliance to maintain certifications and regulatory approvals.
• Oversee the development, implementation, and maintenance of the QMS to ensure compliance with FDA regulations (e.g., 21 CFR Part 111).
• Product Compliance:
• Review product formulations, labeling, and marketing materials to ensure compliance with regulatory requirements.
• Ensure the timely Creation and Approval MMR/BPR in compliance to CFR.
• Work closely with cross-functional teams (e.g., R&D, Marketing, Legal) to assess regulatory risks and develop strategies for compliance.
• Maintain product registration and listing information with regulatory authorities as required.
• Quality Assurance:
• Collaborate with the quality assurance team to establish and maintain robust quality management systems that comply with relevant quality standards, such as Sanitation, HACCP, GMP, and ISO standards.
• Ensure that appropriate quality control measures are in place throughout the production process, including raw material inspection, in-process checks, and finished product testing.
• Manage, monitor and perform change requests and deviations, ensuring resolution within required timelines and in compliance with applicable standards.
• Develop and implement programs to monitor and assess product quality, including complaint management, trend analysis, and customer feedback and services.
• Drive continuous improvement initiatives to enhance product quality, safety, and customer satisfaction.
• Develop and track KPI metrics of Quality Assurance and Regulatory Affairs.
• Training and Communication:
• Provide training and guidance to employees on compliance requirements, standards, and procedures to ensure a high level of awareness and understanding.
• Develop and deliver compliance-related training programs to employees at all levels of the organization.
• Foster a culture of compliance by promoting awareness, accountability, and continuous improvement in compliance practices.
• Communicate compliance updates, regulatory changes, and best practices to relevant stakeholders to ensure organizational compliance.
• Documentation and Recordkeeping:
• Maintain accurate and up-to-date records of regulatory compliance activities, including documentation of product testing, labeling reviews, and regulatory submissions.
• Ensure that documentation is organized and accessible for audits and inspections.
• Additional duties as assigned.

Supervisory Responsibilities

Yes, Supervisory Responsibilities

Minimum Qualifications

Education:

Bachelor's degree in food science, food technology, or related field. A master’s degree is preferred.

Certificate ISO-9001 of Lead Auditor, Foreign Supplier Verification Programs, FSPSCA Adulteration and Mitigation, HACCP 117, Equipment, Clean and Validation, Quality Management of QMS Business.

Combination of education and work experience may be considered.

Knowledge

• Extensive experience (10 years) in compliance management within the dietary supplement industry and/or food industry
• Thorough understanding of the regulatory guidelines for dietary supplements such as FDA cGMP, DSHEA, FTC, food safety regulations, quality standards, and labeling requirements.
• Familiarity with regulatory bodies and guidelines, such as FDA, USDA, CFIA, and local regulatory authorities.
• Strong knowledge of quality management systems, including HACCP, GMP, and ISO standards.
• Minimum 3 years hands-on management experience leading regulatory specialists or quality teams in a manufacturing environment.
• Excellent understanding of food production processes, sanitation practices, and supply chain operations.
• Attention to detail with excellence.

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.

Lief is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request accommodation, contact the Lief Human Resources department.

Lief will consider employment-qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring.

Lief uses E-Verify to confirm work eligibility in the United States. E-Verify compares the information on your Form I-9, Employment Eligibility Verification, to official government records.