What are the responsibilities and job description for the Quality & Regulatory Manager position at Purus Manufacturing LLC?
About the Role
Purus Manufacturing LLC is a dietary supplement manufacturing company based in Northridge, California. We are looking for an experienced Quality & Regulatory Manager to lead our quality and regulatory functions, ensure compliance with applicable industry requirements, and support high standards across our manufacturing operations.
This is a full-time, on-site position at our Northridge, California facility.
Key Responsibilities
- Lead and continuously improve the company's Quality Management System (QMS) and overall quality standards.
- Ensure compliance with applicable FDA regulations, cGMP requirements, and internal quality standards.
- Oversee Quality Assurance and Regulatory Affairs activities across manufacturing operations.
- Lead quality investigations, corrective and preventive actions, and continuous improvement initiatives.
- Ensure products, manufacturing processes, and quality practices consistently meet established regulatory and quality requirements.
- Lead internal audits and support regulatory inspections and external GMP audits.
- Oversee supplier quality and qualification programs and ensure appropriate quality oversight of external partners.
- Provide regulatory guidance for product development, ingredients, labeling, packaging, and related business activities.
- Lead and develop the Quality & Regulatory team and provide guidance to cross-functional teams.
- Partner with Production, Operations, Product Development, Supply Chain, and Executive Leadership to support compliance and company growth.
Qualifications
- Bachelor's degree in Chemistry, Biology, Food Science, Microbiology, Quality Assurance, Regulatory Affairs, or a related scientific field.
- 5–7 years of progressive experience in Quality Assurance and/or Regulatory Affairs within dietary supplements, pharmaceuticals, food, cosmetics, or another FDA-regulated manufacturing environment.
- 3 years of leadership or management experience.
- Strong knowledge of FDA regulations and cGMP requirements.
- Proven experience managing quality systems, regulatory compliance, audits, and inspections in an FDA-regulated manufacturing environment.
- Strong understanding of manufacturing processes, quality standards, and continuous improvement practices.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication, leadership, and cross-functional collaboration skills.
- Experience with electronic Quality Management Systems (eQMS) is a plus.
What We Offer
- Competitive salary based on experience and qualifications.
- Paid vacation and sick leave.
- 401(k).
- A key leadership role with direct impact on quality and regulatory operations.
- Opportunities to contribute to process improvement and company growth.