Quality Manager III
Quality Assurance Manager III
Location: Morristown, TN
Employment Type: Full-Time, On-Site
Salary Range: $103K-$157K
Position Summary
A leading manufacturing organization is seeking a Quality Assurance Manager III to provide leadership across Quality Assurance, Quality Control, Quality Systems, and Quality Engineering functions. This role will drive compliance, continuous improvement, and strategic quality initiatives to ensure product safety and regulatory alignment in an FDA-regulated environment.
Key Responsibilities
- Oversee QA/QC/QE operations and ensure compliance with FDA, cGMP, and ISO standards
- Lead internal and external audits, manage CAPA, and support regulatory inspections
- Drive quality system improvements, process validation, and new product introduction initiatives
- Collaborate with cross-functional teams to achieve plant and global quality goals
- Manage quality metrics, reporting, and strategic planning activities including Annual Management Reviews
Qualifications
- Bachelor's degree in Science, Engineering, or related technical discipline
- 10+ years of Quality Assurance management experience in FDA-regulated manufacturing (pharma or medical device preferred)
- Strong knowledge of 21 CFR 11, 210, 211, 820, cGMP, ISO 13485, risk management, and auditing
- Experience with process validation, cleaning validation, software validation, and technology transfer
- Preferred certifications: ASQ CQA/CQE, RAPS, or similar
Salary & Benefits
- Competitive compensation package
- Comprehensive benefits including medical, dental, vision, and 401(k)
- Paid time off and professional development opportunities
- Relocation Assistance: Provided
- Visa Sponsorship: Not available
FAQs
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