Manager, QA Operations

Job Description

• The Manager, QA Operations ensures compliance with the quality system's procedures and assessing regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices. • This role is accountable for routine Quality Assurance duties related to the production and disposition of products manufactured and tested on behalf of Neogene. • The role is based in Santa Monica, CA, and reports to the Director of Quality.

Qualifications

• Bachelor's degree with a minimum seven (7) years of experience OR Master's Degree and a minimum five (5) years of experience OR PhD with a minimum of two(2) years experience in a GMP environment. • Knowledge of and ability to apply GMP in conformance to US, EU and ROW standards. • Proficient in cGMP regulations, quality systems, and regulatory requirements. • Experience writing, evaluating, and closing investigations, CAPAs, and change control records. • Experience conducting internal and external audits. • Willing to accept temporary responsibilities outside of initial job description. • Ability build collaboration amongst individuals. • Proficient in MS Word, Excel, Power Point and other applications. • Willingness to think outside of the box and adapt best practices for stage appropriate products. • Demonstrate organizational, prioritization, and proficiency.

Benefits

• Short-term incentive bonus opportunity • Equity-based long-term incentive program • 401(k) plan • Paid vacation and holidays; paid leaves • Health benefits including medical, prescription drug, dental, and vision coverage.