Job Description
Job Description
The Quality Director will possess the skillset and experience base to execute our entire QMS. Reporting to our Vice President of Quality and Regulatory, the Quality Director role will be responsible for compliance as well as ensuring the effectively collaboration between the entire QA team and the various departments in the business including Operations, Purchasing, Inventory, Sales, and Finance.
Key Responsibilities:
- Oversee and continue to build out the quality team, including staffing, training, and ongoing development.
- Execute, and continue to develop, implement, and update SOPs across manufacturing, testing, and documentation workflows for medical devices, OTC products, and cosmetics.
- Maintain and renew key certifications and regulatory requirements (cGMP, FDA registration, ISO 13485, OTC monograph compliance, cosmetic GMP).
- Lead audit preparation, on-site audits, and follow-up activities.
- Design and execute document control processes, including electronic batch records, deviations, CAPAs, and change management.
- Oversee product quality systems: incoming inspection, in-process checks, finished goods release, stability studies, and complaint handling.
- Partner with production, R&D, and commercial teams to embed quality throughout the product lifecycle.
- Track and improve quality metrics such as defect rates, audit findings, and out-of-specification events.
- Ensure all activities align with FDA, industry standards, and applicable international regulations.
Qualifications
- 5-10+ years of QA Leadership experience in contract manufacturing, ideally with exposure to OTC products, medical devices, and cosmetics.
- Experience building quality systems and teams, especially in a scale-up or startup environment.
- Strong knowledge of regulatory standards including 21 CFR Part 210/211, cGMP, and cosmetic regulations.
- Hands-on experience writing SOPs, implementing QMS processes, and managing document control.
- Excellent project management and multitasking capabilities.
- Effective communicator able to train teams and interact confidently with auditors.
- Bachelor's degree in a relevant scientific or engineering discipline preferred; ASQ certifications are a plus.
- Detail-oriented, proactive, and adaptable in a dynamic environment.
This role offers a competitive salary, with a great compensation package, and strong opportunities for growth.
Company DescriptionInSpec Solutions, LLC is a market leading contract manufacture of topical OTC and Cosmetic Products. We are experience rapid growth and can offer boundless opportunities for growth.
Company Description
InSpec Solutions, LLC is a market leading contract manufacture of topical OTC and Cosmetic Products. We are experience rapid growth and can offer boundless opportunities for growth.