Quality Assurance & Regulatory Affairs Manager (On-site)

Lief Labs; Valencia; Presencial; VES 12.103.000 - 16.138.000; Jornada completa

Descripción de la vacante

A leading dietary supplement manufacturer is seeking a Quality Assurance & Regulatory Affairs Manager to ensure compliance with FDA regulations and manage quality systems. The ideal candidate will possess extensive experience in the dietary supplement industry, strong communication skills, and the ability to lead cross-functional teams. This role is on-site in Valencia, CA and offers a competitive salary along with comprehensive benefits.

Servicios

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Life insurance

Wellness benefits

Education reimbursement

PTO

Formación

• 5+ years in compliance management within dietary supplements or food industry.
• Deep knowledge of FDA regulations, DSHEA, and FTC guidelines.
• Experience with quality systems, audits, and CAPA management.

Responsabilidades

• Ensure all products comply with FDA and international regulations.
• Review and approve product labeling and marketing materials.
• Conduct internal audits to assess compliance and recommend corrective actions.

Conocimientos

Problem Solving

Verbal Communication

Relationship Management

Time Management

Attention to Detail

Educación

Bachelor's degree in Life Sciences, Chemistry, Nutrition, or related field

Master’s degree

Herramientas

Quality Management Systems

HACCP

GMP

ISO standards

Descripción del empleo

Current job opportunities are posted here as they become available.

Quality Assurance & Regulatory Affairs 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 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

Minimum Qualifications

Education:

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
• Verbal Communication
• Relationship Management
• Time Management
• Ability to interact at all levels
• Ability to work as a team member

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.