BodyHealth
Quality Assurance / Regulatory Affairs Manager - Supplement Industry
BodyHealth, Dunedin, Florida, us, 34697
Job Role:
As the Quality Assurance & Regulatory Affairs Manager, you will safeguard the integrity, safety, and compliance of all BodyHealth products by overseeing end-to-end quality processes. While BodyHealth
does not manufacture in-house,
you will serve as the primary liaison between our company and our manufacturing, packaging, and testing partners, ensuring our products meet or exceed all FDA, NSF, and industry standards. This role is both strategic and hands-on, requiring leadership in quality systems, supplier oversight, regulatory compliance, and continuous improvement.
Job Summary:
Key Responsibilities: Quality Leadership & Strategy
Develop, implement, and maintain BodyHealth’s Quality Management System (QMS) to meet FDA CFR 111/117, NSF, and other applicable regulatory requirements. Create a multi-year quality roadmap aligned with company growth, innovation, and compliance objectives. Lead internal and external audits, ensuring a state of inspection readiness at all times.
Supplier & Manufacturer Oversight
Qualify, approve, and regularly audit manufacturing and packaging partners to ensure ongoing compliance with GMP and NSF standards. Establish and maintain robust quality agreements with all manufacturing partners, defining roles, responsibilities, and escalation protocols. Resolve quality-related issues with suppliers quickly, diplomatically, and effectively.
Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.
Product Quality Control
Oversee product release processes, including review of Certificates of Analysis (CoA), laboratory results, and batch records before market release. Conduct independent verification testing (microbial, heavy metals, potency, stability) via third-party labs. Ensure packaging components meet quality specifications through visual, dimensional, and functional checks.
Regulatory Compliance
Maintain thorough knowledge of FDA, FTC, NSF, and state regulations impacting dietary supplements. Ensure product labels are compliant with all applicable regulations, including ingredient listings, claims substantiation, and allergen statements. Keep detailed records to support regulatory inspections and inquiries. Manage site HACCP/Food Safety Plan.
Continuous Improvement & Risk Management
Implement corrective and preventive action (CAPA) programs to address quality issues and prevent recurrence. Develop recall readiness plans and lead mock recall drills to ensure company preparedness. Use data analytics and trend analysis to proactively identify risks and optimize quality processes.
Cross-Functional Collaboration
Partner with R&D during new product development to ensure manufacturability, regulatory compliance, and scalability. Support marketing and customer service by providing technical product quality information and resolving consumer complaints. Train internal teams on GMP awareness, product handling, and quality procedures.
Qualifications:
Required: Minimum 5 years of Quality Assurance/Quality Control/Regulatory Affairs experience in the dietary supplement or food industries. Deep understanding of FDA CFR 111/117 requirements and NSF certification processes. Proven experience managing supplier/manufacturer relationships and conducting audits. Strong problem-solving skills, attention to detail, and the ability to balance regulatory rigor with business needs.
Preferred: Bachelor’s degree in a scientific discipline (Food Science, Chemistry, Biology, or related field). Experience with NetSuite or other ERP/inventory management systems. Familiarity with ISO 9001 or other quality management frameworks. PCQI (Preventative Control Qualified Individual)
Core Competencies Regulatory Expertise: Confident navigating FDA, FTC, and NSF requirements. Analytical Thinking: Able to interpret complex lab data and identify trends. Communication: Skilled at influencing and negotiating with external partners. Adaptability: Thrives in a fast-paced, high-growth environment with evolving priorities.
Language Skills: Must speak English. Must have solid written and verbal communication skills, ability to pay attention to detail and maintain confidentiality, strong interpersonal skills, and commitment to working with a diverse staff are essential to successful carry out the duties of this position. Excellent ability to communicate. Ability to draft reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers and employees.
Physical Demands: While performing the duties of this job, one will be sitting for 4+ hours at a time, lifting up to 25lbs of products, moving around the office to coordinate with other team members.
Work Environment: Office Environment
Hours: This is a full- time salaried position with a minimum of 40 hours per week in the office, from 9:00am to 6:00pm Monday through Friday.
Other Duties: Note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities required of the employee for this job. Duties, responsibilities and activities may change with or without notice. It is expected that this position work to achieve the goals of the organization, whether specific duties are mentioned or not.
does not manufacture in-house,
you will serve as the primary liaison between our company and our manufacturing, packaging, and testing partners, ensuring our products meet or exceed all FDA, NSF, and industry standards. This role is both strategic and hands-on, requiring leadership in quality systems, supplier oversight, regulatory compliance, and continuous improvement.
Job Summary:
Key Responsibilities: Quality Leadership & Strategy
Develop, implement, and maintain BodyHealth’s Quality Management System (QMS) to meet FDA CFR 111/117, NSF, and other applicable regulatory requirements. Create a multi-year quality roadmap aligned with company growth, innovation, and compliance objectives. Lead internal and external audits, ensuring a state of inspection readiness at all times.
Supplier & Manufacturer Oversight
Qualify, approve, and regularly audit manufacturing and packaging partners to ensure ongoing compliance with GMP and NSF standards. Establish and maintain robust quality agreements with all manufacturing partners, defining roles, responsibilities, and escalation protocols. Resolve quality-related issues with suppliers quickly, diplomatically, and effectively.
Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.
Product Quality Control
Oversee product release processes, including review of Certificates of Analysis (CoA), laboratory results, and batch records before market release. Conduct independent verification testing (microbial, heavy metals, potency, stability) via third-party labs. Ensure packaging components meet quality specifications through visual, dimensional, and functional checks.
Regulatory Compliance
Maintain thorough knowledge of FDA, FTC, NSF, and state regulations impacting dietary supplements. Ensure product labels are compliant with all applicable regulations, including ingredient listings, claims substantiation, and allergen statements. Keep detailed records to support regulatory inspections and inquiries. Manage site HACCP/Food Safety Plan.
Continuous Improvement & Risk Management
Implement corrective and preventive action (CAPA) programs to address quality issues and prevent recurrence. Develop recall readiness plans and lead mock recall drills to ensure company preparedness. Use data analytics and trend analysis to proactively identify risks and optimize quality processes.
Cross-Functional Collaboration
Partner with R&D during new product development to ensure manufacturability, regulatory compliance, and scalability. Support marketing and customer service by providing technical product quality information and resolving consumer complaints. Train internal teams on GMP awareness, product handling, and quality procedures.
Qualifications:
Required: Minimum 5 years of Quality Assurance/Quality Control/Regulatory Affairs experience in the dietary supplement or food industries. Deep understanding of FDA CFR 111/117 requirements and NSF certification processes. Proven experience managing supplier/manufacturer relationships and conducting audits. Strong problem-solving skills, attention to detail, and the ability to balance regulatory rigor with business needs.
Preferred: Bachelor’s degree in a scientific discipline (Food Science, Chemistry, Biology, or related field). Experience with NetSuite or other ERP/inventory management systems. Familiarity with ISO 9001 or other quality management frameworks. PCQI (Preventative Control Qualified Individual)
Core Competencies Regulatory Expertise: Confident navigating FDA, FTC, and NSF requirements. Analytical Thinking: Able to interpret complex lab data and identify trends. Communication: Skilled at influencing and negotiating with external partners. Adaptability: Thrives in a fast-paced, high-growth environment with evolving priorities.
Language Skills: Must speak English. Must have solid written and verbal communication skills, ability to pay attention to detail and maintain confidentiality, strong interpersonal skills, and commitment to working with a diverse staff are essential to successful carry out the duties of this position. Excellent ability to communicate. Ability to draft reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers and employees.
Physical Demands: While performing the duties of this job, one will be sitting for 4+ hours at a time, lifting up to 25lbs of products, moving around the office to coordinate with other team members.
Work Environment: Office Environment
Hours: This is a full- time salaried position with a minimum of 40 hours per week in the office, from 9:00am to 6:00pm Monday through Friday.
Other Duties: Note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities required of the employee for this job. Duties, responsibilities and activities may change with or without notice. It is expected that this position work to achieve the goals of the organization, whether specific duties are mentioned or not.