Job Summary
The Director of Quality and Regulatory at Adept Life Sciences provides strategic leadership and oversight of the company’s Nutracuetical Quality and Regulatory, serving as the final authority to ensure compliance with cGMP, FDA regulations, and company policies. This role manages quality across materials, manufacturing, laboratory testing, documentation, audits, CAPA, change control, and finished product release, ensuring safe, high-quality dietary supplement products that meet regulatory and customer requirements. The Director fosters a culture of compliance, accountability, and continuous improvement, leads audit readiness and supplier qualification, and drives system enhancements to support operational excellence and regulatory compliance. Experience in Nutraceutical Manufacturing is a MUST.
Duties
- The Director of Quality is responsible for the strategic planning, direction, and implementation of quality systems to deliver safe, high-quality products that meet customer requirements
- Provide strategic leadership and serve as the final quality authority over the Quality Management System to ensure compliance with FDA regulations and cGMP standards.
- Ensure all FDA registrations, cGMP certifications, and regulatory documentation remain current and accurate.
- Lead, train, and develop staff while actively promoting a culture of compliance, continuous improvement, and accountability.
- Maintain current knowledge of regulatory requirements and industry best practices to drive system enhancements.
- Oversee the receiving of raw materials and perform initial quality checks to ensure adherence to established identity and purity specifications. Formally approve or reject raw materials and components based on testing results and COA verification.
- Qualify and oversee suppliers, contract manufacturers, and contract laboratories through audits and performance monitoring. Plan and conduct supplier audits and monitor the effectiveness of their corrective actions.
- The Director provides direct quality oversight during production for all dosage forms, including liquids, blending, and encapsulation. Oversee both internal and contract laboratory functions to verify that the final product meets all safety and potency standards.
- Maintaining a state of constant readiness for external inspections and supporting the transition of new products to commercial batches.
Qualifications & Skills
Education (Required)
- Bachelor’s degree required
Skills (Required)
- Nutraceutical Manufacturing experience.
- Proficiency in complex math, computer systems, technical reading, and writing.
- Languages: Desired fluency in additional languages to support a diverse workforce.
- Adaptability: A willingness to learn new tasks and procedures as the regulatory environment evolves.
- Lead, train, and develop staff while promoting a culture of compliance, continuous improvement, and accountability.
- Maintain current knowledge of regulatory requirements and industry best practices.
- Familiarity with manufacturing documentation (COAs, specs, labels, etc.).
Work Environment & Physical Requirements
- Primarily office-based, computer work up to 8 hours per day
- Sitting for extended periods
- Frequent communication via phone, email, and in-person discussions
- Occasional work in a fast-paced production support environment
Pay: From $90,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Paid time off
Application Question(s):
- What are your pay expectations for the position?
Work Location: In person
