Our client, a leader in the development and production of high-quality color cosmetics, skin care, hair care, bath & body care and OTC products, is seeking a Director of Quality to continue developing, implementing and managing quality initiatives across all departments.
Director of Quality Overview
Provide leadership & support to Quality Assurance and Quality Control across all facets of production, including customer service, R&D, batching, manufacturing, and internal and external auditing. Be the point of contact for all quality concerns for QA/QC, Engineering, Operational personnel, Customers, and Regulatory Agencies.
Key Success Factors:
- Primary contact during cGMP, Environmental, and Regulatory audits.
- Set quality goals and objectives with the assistance of senior management.
- Lead all investigations (complaints, non-conformities, supplier issues, audit findings,
etc.); correspondences to regulatory audits; and registration of products and facility with
- Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA,
OSHA, ISO 13485:2003).
- Responsible for all material and product approvals, releases, and rejections.
- Responsible for quality control and quality assurance of materials, intermediates, and
- Responsible for periodic quality reviews, regulatory updates, and annual GMP training
- Responsible for formal drug stability program, process validation, calibration program,
change management, co-ordination of employee training program.
- Responsible for supplier qualification program, contract laboratory and vendor audits;
internal and external audits.
- Responsible for SOPs, Specification controls, and Change Control program.
- Responsible for the quality management system (QMS) in compliance with 21CFR 210,
211, and 820, and key elements of ISO 13485:2003.
- Must be familiar with regulatory requirements for formula and product development
pertaining to cosmetic, OTCs, medical devices.
- 8+ years of experience with cosmetics/personal care contract manufacturer.
- 5 yrs experience in Sr. Management position.
- BS in Life Sciences, Engineering, or other related fields.
- Extensive experience inspecting and auditing in manufacturing.
- Excellent Microsoft Office, math & data organizing skills.
- Strategic partner heavily impacting the growth and direction of a flourishing company.
- Competitive salary, bonus incentive and health benefits package.
- Privately-owned company with minimum red tape.
- Thriving culture with a family feel.
- Relocation assistance.