The Manager, Quality Assurance Plant Operations, is responsible for leading QA plant operations and expertise in manufacturing plant operations. This includes developing QA specific procedures related to product disposition, line clearance and review and approval of GMP documentation including but not limited to Batch Records, QC test methods and Calibration/Work Order Records. The candidate will also 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: • Lead the day to day operations for the Quality Assurance team. This includes but is not limited to oversight of product disposition, deviation, CAPA, Change Control, and training. • 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 • Lead product disposition • Support Health Authority Inspections and Client Audits • Mentor personnel within QA and cross functionally on GMP compliance, promote quality culture • 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: • 10+ years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing. Cell therapy experience preferred. • Minimal 4 years leadership experience as a supervisor/leader or manager. • 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. Department Quality Assurance Locations Hopkinton Yearly salary $130,000 - $190,000 Employment type Full-time