Quality Assurance Lead, Plant Operations

The, Quality Assurance Lead, Plant Operations, is responsible for leading QA plant operations and expertise in manufacturing plant operations. This includes batch review, product disposition, review and approval of GMP documentation including but not limited to QC test methods and Work Order Records. The candidate will lead product receipt, shipment and disposition, line clearance and quality system review/ approval in the QA role. This is a full-time, on-site role at our Hopkinton, MA location. Weekends and holidays may be required. How You Will Make an Impact: • Supervise and lead Quality Assurance team, including coaching and mentoring. • Coordinate day-to-day operations for the Quality Assurance team. This includes but is not limited to oversight of batch record review, QC data review, deviations, CAPA, Change Control, and training. • Provide QA support to manufacturing operations and ensure compliance with cGMP requirements. • Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement • Work cross functionally and provide QA support for development, review and approval of procedures/workflows for manufacturing operations • Provide QA review and approval of plant related SOPs and GMP documentation • Other duties as assigned. What You Will Bring: • A highly organized work style that ensures timely execution of tasks. • A mindset that ensures accurate results. • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). • Effective problem-solving capabilities. • Strong oral and written communication skills. Qualifications: • 7+ years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing. Cell therapy experience preferred. • Previous leadership or supervisory experience • Prior experience in Quality Assurance Operations focused on support of internal manufacturing operations. • Prior experience working in contract services and interfacing with clients preferred • Ability to partner cross functionally and be quality lead within agreed timelines to support plant start up activities • Ability to resolve issues and make decisions independently and escalate complex decisions as needed. • Partner cross functionally and provide quality support within agreed timelines to support plant start up activities. • Well versed in cGMP and ICH regulations / guidelines • Strong verbal and written communication skills Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs. At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.