Manager, Quality Assurance

QA Operations Manager (Day Shift) Location: Portsmouth, NH (On-site) As a QA Operations Manager, you will lead a high-performing Quality Assurance team responsible for quality oversight of manufacturing operations, batch documentation review, and product disposition readiness in a fast-paced GMP manufacturing environment. This role offers the opportunity to influence quality strategy, partner closely with Manufacturing and Technical Operations, and drive continuous improvement initiatives that support the delivery of life-changing therapies. You'll play a critical leadership role in ensuring compliance, operational excellence, and inspection readiness while developing and mentoring a team of quality professionals. Shift: Day Shift What you will get - An agile career and dynamic working culture - Opportunities to lead, coach, and develop a team of Quality Assurance professionals - Exposure to complex biologics manufacturing and quality operations - A collaborative environment working closely with Manufacturing, Supply Chain, Technical Operations, and Quality teams - Compensation programs that recognize high performance - Medical, dental, and vision insurance - Opportunities for career growth and leadership development What you will do - Lead daily QA Operations activities, providing quality oversight and support for manufacturing operations while ensuring compliance with cGMP and regulatory requirements - Manage batch documentation review activities, product disposition readiness, and documentation quality to support timely and compliant product release - Provide quality guidance and risk-based decision-making for manufacturing activities, quality events, compliance issues, and operational challenges - Oversee deviations, investigations, CAPAs, change controls, risk assessments, and quality event management to ensure timely resolution and sustainable compliance - Lead, coach, develop, and resource-plan QA Operations personnel while fostering a collaborative, accountable, and performance-driven team environment - Partner with Manufacturing, Supply Chain, Technical Operations, and Quality stakeholders to identify risks, resolve issues, and support operational success - Drive operational excellence through performance metrics, continuous improvement initiatives, standardization efforts, and the implementation of new systems, tools, and processes What we are looking for - Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or a related discipline; advanced degree preferred - Minimum 7 years of Quality Assurance experience within a GMP-regulated biopharmaceutical, pharmaceutical, or biotechnology environment - Minimum 3 years of supervisory or management experience within a Quality organization - Experience supporting manufacturing quality oversight, quality systems, operational quality management, and batch documentation review activities - Strong knowledge of FDA, EMA, and global GMP requirements, including deviations, CAPAs, investigations, change controls, and product disposition processes - Proven leadership experience with the ability to coach teams, manage priorities, and drive continuous improvement initiatives - Strong communication, problem-solving, stakeholder management, and risk-based decision-making skills in a dynamic manufacturing environment