Precision Life Sciences
Quality Vendor Manager
We are looking for a seasoned Quality Compliance professional who will provide assessment on company sites, internal GMP departments, external partners, and quality systems for ensuring compliance with regulatory requirements and expectations, standards, industry trends, and regulatory commitments as well per company policies and procedures. Incumbent will support readiness for regulatory inspection and will collaborate across the regional organization to participate in cGMP and GDP compliance initiatives and continuous improvement. The role will report to Lead, Quality & Compliance.
- Establish, deploy, and manage the development of an effective supplier quality auditing / assessment program
- Perform audit on North America sites and systems (Canada, Middleburgh, Princeton, and Shreveport)
- Coordinate and / perform new product pre-approval audit of external partners and internal sites
- Maintain and enhance the Supplier management process using quantitative methods to identify high-risk suppliers
- Maintain Regional Supplier Qualification Reports, Audit Reports
- Prepare, maintain, and provide quarterly signed versions of the North America business Approved Vendor List
- Support regulatory compliance oversight of North America business and identify areas for correction to eliminate compliance gaps
- Proactively research new and upcoming regulations and guidelines
- Supports the Regional Quality Council and Coordinates compliance metrics for North America and provides periodic updates to Executive Management through a Quality Review meeting and a Regional Quality Council
- Prepare, revise, and execute quality agreements with all vendors in the quality system
Qualification / Skills:
- B.S. or M.S. in Chemistry, Biology or other life sciences is preferred. Auditing Certification is preferred
- 8+ years of progressive experience in auditing pharmaceutical or medical device systems, this experience should include 2 years of internal and external audit management
- Strong understanding of pharmaceutical, combination product or medical device manufacturing, packaging and testing processes, and management of Quality Management Systems
- Thorough understanding and familiarity with auditing, GMP regulations, including 21 CFR 210, 211, 820, ICH guidelines, IPEC guidelines, FDA guidance documents
- Required to travel domestically and internationally
- Excellent verbal and written communication skills, organizational and time management skills; strong attention to detail
- Strong writing skills as a result of producing technical documents such as Standard Operating Procedures, Summaries, investigation reports, audit reports, and technical change control.
- Understanding of QMS in pharmaceutical manufacturing and packaging facilities and excipients manufacturers
PRECISION LIFE SCIENCES
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