Pharma: Quality Assurance Manager
HKA Enterprises
We are hiring a Quality Assurance Specialist (Supplier Quality Management)! This individual contributor role supports clinical and commercial product compliance by managing supplier performance, maintaining QA procedures, and serving as a Subject Matter Expert (SME) during regulatory inspections. Key Responsibilities: Perform QA assessments, approvals, and qualifications for suppliers and incoming materials. Interpret cGXPs for commercial and clinical manufacturing environments. Resolve complex supplier quality issues independently and implement process improvements. Support regulatory audits, provide performance metrics, and coach junior team members. Qualifications: Education & Experience: Bachelor’s degree in Science + 4 years of experience (or Master’s + 2 years, PhD + 0 years, Associate’s + 8 years, HS Diploma + 10 years). Industry Experience: Proven experience in manufacturing, quality, or engineering within the biotech or pharmaceutical industry. Skills: Strong communication, cGXP knowledge, and supplier management expertise. Preferred: Prior experience with QA supplier management, quality agreements, and supply chain. Note: Visa sponsorship is not available for this position. Candidates must be currently eligible to work in the U.S. without sponsorship. #BiotechJobs #PharmaJobs #QualityAssurance #SupplierQuality #cGXP #QAJobs #J-18808-Ljbffr
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