Manager, QA Operations

Manager, QA Operations (Quality Assurance) Responsibilities Manage day‑to‑day Quality Assurance operations and training for direct reports. Implement and periodically evaluate documentation and policies to ensure compliance with organizational quality standards, ISO 13485:2016, and statutory/regulatory requirements. Collaborate with management to close documentation/process gaps; address CAPAs, NCs, and audit findings. Author and maintain quality documentation; oversee timely reviews of work instructions for production and quality control. Support Quality Control with customer complaints and Out of Specification (OOS) investigations. Participate on core teams; provide QA deliverables from production through testing and shipment. Implement and track quality management performance metrics. Identify and implement efficiency improvements for Continuous Improvement. Collect and analyze quality data to facilitate proactive solutions. Manage the Internal Audit Program. Perform other duties as required. Qualifications/Skills Bachelor’s degree in Life Science, Biology, Chemistry, Pharmaceutical, or related field. 3–5 years managerial experience in non‑academic biotechnology; 1–3 years supervisory experience. Proven experience with ISO 13485 certification and regulations 21 CFR 820 and 21 CFR Part 11. GMP environment experience preferred. Thorough knowledge of analytical testing standards and QA methodologies. Excellent communication and presentation skills; strong scientific problem‑solving; ability to collaborate in a fast‑changing/start‑up environment. Detail‑oriented, results‑driven; self‑starter; proven coaching, mentoring, and leadership. Benefits Medical plans with HSA/FSA options RSU/stock purchase plan Fertility and family planning assistance Additional optional benefits, including pet insurance Retirement contributions Holidays and paid time off #J-18808-Ljbffr Scorpion Therapeutics