Sr Manager Quality Control

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Control Job Category: People Leader All Job Posting Locations: Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America Job Description: JOB DESCRIPTION Position Title: Senior Manager, Quality Control Department Name: Quality Control Reports To: Site Quality Head Location: Malvern (primary) and Spring House (secondary), Pennsylvania About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Position Summary: The Senior Manager, Quality Control (QC) is a strategic, multi-site people leader accountable for the compliant, reliable, and efficient operation of QC testing laboratories supporting biotherapeutic and advanced therapy programs at Malvern and Spring House. This position is a member of the Site Quality Leadership Team and reports directly to the Site Quality Head. The role provides end-to-end oversight of laboratory operations supporting clinical and commercial products, including testing strategy, method lifecycle, data review, investigations, capacity, resources, and inspection readiness. The Senior Manager leads an organization of 80+ full-time employees and contractors across both sites. This leader establishes an integrated operating model, develops leaders and technical talent, ensures timely delivery of high-quality test results, and partners with Manufacturing, Quality Assurance, Analytical Development, Technical Operations, Supply Chain, Regulatory, and external laboratories to protect product quality, patient safety, and supply continuity. The incumbent is expected to serve as a competent delegate for the Site Quality Head, as assigned. Key Responsibilities: People Leadership & Strategy Lead, develop, and retain a multi-site QC organization of 80+ full-time employees and contractors, including managers, supervisors, analysts, and support roles. Set the QC vision, organization design, operating model, goals, performance expectations, succession plans, and workforce strategy for Malvern and Spring House. Exercise leadership authority for talent acquisition, performance management, development, recognition, compensation recommendations, promotions, employee relations, organizational design, and appropriate corrective actions in partnership with Human Resources. Build a culture of quality, safety, accountability, inclusion, technical excellence, collaboration, and continuous improvement. Multi-Site QC Laboratory Oversight Provide integrated oversight of QC testing laboratories supporting biotherapeutics and advanced therapies, including cell and gene therapy programs, across Malvern and Spring House. Ensure accurate and timely sampling, testing, review, approval, and reporting for raw and incoming materials, in-process samples, drug substance, drug product, release, stability, environmental and utility monitoring, validation studies, reagents, media, and buffers, as applicable. Oversee sample management, reference standards, critical reagents, laboratory inventory, and the qualification, calibration, maintenance, and lifecycle management of QC equipment. Oversee the lifecycle of diverse analytical platforms and assays, including identity, purity, potency, safety, microbiological, molecular, cell-based, and compendial methods, with appropriate controls for complex and time-sensitive advanced therapy products. Ensure effective execution of method development support, qualification, validation, transfer, and verification activities, together with QC support for Process Performance Qualification, Continued Process Verification, and product comparability. Compliance, Data Integrity & Laboratory Performance Maintain laboratory compliance with applicable cGMP requirements, global quality standards, approved procedures, data integrity principles, and health, safety, and environmental expectations. Ensure robust governance and timely closure of nonconformance investigations, invalid assays, out-of-specification and out-of-trend results, laboratory investigations, CAPAs, change controls, method transfers, qualifications, and validations. Maintain validated, reliable, and inspection-ready computerized laboratory systems, including eLIMS, Empower, and other systems used for sample, instrument, method, and data management. Provide accurate QC data and trend analyses for annual product reviews, quarterly management reviews, Continued Process Verification, investigations, regulatory submissions, and product quality complaint assessments. Establish and monitor leading and lagging metrics for testing delivery, right-first-time performance, backlog, cycle time, capacity, compliance, and reliability; lead recovery and risk-mitigation plans when performance is off target. Technical Strategy, Business Partnership & Inspection Readiness Define and execute the multi-site QC strategy, including laboratory capacity, headcount and contractor planning, scheduling, asset and facility needs, digital laboratory systems, automation, operating budgets, and strategic capital projects. Partner with Manufacturing, Quality Assurance, Analytical Development, Technical Operations, Supply Chain, Regulatory, Procurement, and external testing laboratories to support technology transfers, product introductions, supplier material qualification, reduced-testing programs, comparability, investigations, release, and supply continuity. Make timely, risk-based decisions within delegated autho