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Vice President of Quality
USD120,000 - USD160,000
- OUTSTANDING CAREER OPPORTUNITY!!
- FAST GROWING COMPANY!
About Our Client
Great opportunity to join a growing cosmetics company!!
- 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 agencies.
- 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 finished products.
- 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.
- Responsible for any additional duties or assignments as directed by the COO, or CEO.
The Successful Applicant
- Minimum of Bachelor degree (Life Sciences, Engineering, related profession)
- Experience of drug product manufacture is a pre-requisite
- Five+ years industry or related experience in cosmetic, medical device, food, or pharma.
- Previous inspecting, auditing or manufacturing experience - a plus.
- Data analysis, specification development skills.
- Computer literate and effective communication skills
What's on Offer