Quality Assurance Manager

QA Manager - Operations Role Overview: Lead the Quality Assurance (QA) operations team within manufacturing, ensuring efficient batch record review, compliance, and quality decision-making to support the delivery of life-changing therapies. Act as a key quality leader, shaping quality strategy, maintaining inspection readiness, and driving continuous improvement across manufacturing processes. Key Responsibilities Oversee daily batch record review activities, ensuring timely and compliant release support.Recruit, train, coach, and develop QA team members, managing workload and performance.Provide guidance on quality and compliance issues, including deviations, CAPAs, investigations, and change controls.Collaborate with Manufacturing to review and resolve batch record observations, ensuring documentation accuracy.Support batch disposition, quality inquiries, and operational decision-making as the primary QA partner.Drive continuous improvement initiatives, quality strategy development, and inspection readiness.Represent QA on cross-functional teams, ensuring adherence to GMP regulations and quality systems. Qualifications & Skills Bachelor’s degree in a scientific discipline.5-10 years of QA experience in GMP-regulated pharmaceutical, biotech, or life sciences environments.Proven leadership in mentoring, coaching, and developing teams.Strong knowledge of GMP regulations, deviations, CAPAs, investigations, and change controls.Experience supporting regulatory inspections and audits.Familiarity with systems like TrackWise, SAP, Syncade, and Microsoft Office.Excellent communication, decision-making, problem-solving, and stakeholder management skills.