Quality Assurance Manager

Quality Assurance Manager Responsibilities

• Ensure adherence to Current Good Manufacturing Practices throughout receipt, sampling, storage, testing, manufacturing, and distribution of raw materials, intermediates, and finished goods.
• Manage and oversee product release, deviation management, technical complaints, annual product reviews, and CAPA processes.
• Lead investigation of deviations and complaints, ensuring thorough documentation and root‑cause analysis.
• Provide QA consultation to project teams and oversee audit and inspection readiness.
• Develop and maintain SOPs, change‑control processes, and performance metrics for quality system improvement.
• Lead the quality assurance team, including performance management, coaching, and succession planning.

• Bachelor’s degree in Biology, Chemistry, Pharmacy, or related field (Master’s preferred); MBA and quality certifications a plus.
• 8–10 years of experience in a pharmaceutical FDA‑regulated environment (CMO experience preferred).
• Prior experience in quality assurance management, facility operation, laboratory compliance, and quality systems.
• Previous supervisory experience; proven ability to influence cross‑functional teams.
• Deep understanding of regulatory requirements and experience with FDA and other regulatory inspections.
• Strong analytical, problem‑solving, and decision‑making skills.
• Proficiency in Track Wise, Microsoft Office (Word, Excel, PowerPoint), Outlook and other relevant software.

Compensation range: $115,000 – $127,000 USD.

• 100 % employer‑paid medical premiums (estimated $2,000–$6,000+ annual value).
• 401(k) contributions: 6 % match plus an additional 4 % company‑funded contribution.
• HSA contributions with wellness incentives.
• Annual performance bonuses and merit increase eligibility.
• Other benefits designed to support health, future, and wellbeing.

Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.