Manager, QA Engineering

Role: QA Engineering Manager (Equipment/Lab Methods/Utilities/Facilities) overseeing quality in site technology transfer activities at a cell therapy manufacturing facility producing CAR T and drug products. Responsibilities: review and approve validation, qualification, and investigation documents for equipment, utilities, and facilities; ensure compliance with GMP, global standards, and data integrity; support validation activities, investigations, and change controls; and provide leadership if managing a team. Qualifications: Bachelor's degree in Science; minimum 5 years of experience in pharma or related industry; deep knowledge of GMP, risk management, validation protocols, and quality systems; proficiency in Microsoft Office, Maximo, and electronic document management tools; strong technical review and leadership skills. High-Value: focus on cell therapy manufacturing, validation and qualification of equipment/utilities/facilities, compliance with cGMP, data integrity, and risk assessment. Work setup: role may be individual contributor or people manager; onsite presence required at NJ site; work environment highly collaborative in a fast-paced biotech setting.