Quality Assurance Manager
Listed on 2026-10-10
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
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.
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.
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.
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