QA/RA & Project Manager

Key responsibilities

Regulatory Affairs (RA)

• Product registrations: Manage and execute the registration and notification of dietary supplements with relevant health authorities (e.g., FDA, Halal, COA)
• Formula, Label & Claims Review: Review and approve product formula, packaging, labels, marketing materials, and websites to ensure compliance with health and nutrition claim regulations
• Regulatory Compliance: Monitor changes in food supplement regulations and communicate impacts to product development and supply chain teams
• Health Authority Liaison: Act as the primary point of contact for regulatory agencies, managing audits and submissions

Quality Assurance (QA)

• QMS Oversight: Maintain, update, and enforce the company's Quality Management System in accordance with GMP (Good Manufacturing Practices) and HACCP standards
• Vendor & Manufacturer Audits: Audit third-party manufacturers (CMOs), raw material suppliers, and testing laboratories to ensure compliance with quality agreements
• Batch Record Review: Review and release finished product batch records, certificate of analysis (COAs), and stability test data
• Non-conformance & CAPA: Lead investigations into product deviations, out-of-specification (OOS) results, and customer complaints, and implement Corrective and Preventive Actions (CAPA)

Product Development Project Manager

• Steer cross-functional teams to deliver their tasks and results per timeline
• Resolve problems for on-going projects.
• Manage supply chain operations for products including barcode, product instructions, and protocols

Qualification Skills

Education & Experience

• Degree: Bachelor's degree in food science, Pharmacy, Chemistry, Biochemistry, or a related scientific field
• Experience: 3+ years of experience in QA/RA roles

Technical Knowledge

• Regulations: Understanding of food supplement regulations
• Certifications: Good working knowledge of GMP, HACCP, ISO 22000, or NSF certification standards
• Testing: Familiarity with analytical testing methods for vitamins, minerals, and botanicals (microbiology, heavy metals, stability testing)

Soft Skills

• Attention to Detail: Meticulous approach to reviewing technical documents, formulations, and legal text
• Communication: Ability to translate complex regulatory jargon into clear guidance for marketing and sales teams
• Problem Solving: Strong analytical skills to handle product deviations and regulatory roadblocks efficiently