CAPA Manager

CAPA Manager – R&D Operations (Remote/Hybrid) Position available for remote or hybrid work in New Jersey and Pennsylvania. The CAPA Manager supports Delivery Units and Investigation Owners in the Corrective Action Preventive Action (CAPA) process for both in‑house and outsourced clinical trials. Key Responsibilities Act as CAPA Champion for regional/global investigator owners of non‑conformances. Serve as process and system SME for the CAPA process, business, and system requirements. Assist Investigation Owners in applying structured problem‑solving methodologies (root‑cause analysis, Fishbone, 5 Whys, etc.). Coach Investigation Owners on their full accountability for the CAPA lifecycle. Develop and maintain proficiency in COMET. Identify and coordinate resources for RCAs and resulting actions. Provide assistance to Investigation Owners to meet process requirements. Monitor CAPA deliverables and timelines, run reports, communicate deadlines, and escalates concerns to management. Act as liaison between Investigation Owners, quality leaders, RCA groups, and Central Data Entry teams. Escalate issues to the R&D Quality CAPA Review Board and attend meetings when required. Raise process or system questions within the CAPA Champions Community of Practice. Collaborate with other CAPA managers/champions on complex CAPAs and related activities. Manage assistance requests from Central Data Entry on behalf of Investigation Owners. Requirements Education: Bachelor’s degree in Science (BSc) or Arts (BA). Minimum 7–8 years of pharmaceutical industry experience, with at least 3–4 years of GXP experience in clinical research, development, and/or quality assurance. Experience: Quality Control and Compliance, CAPA process, Root Cause Analysis, audits of clinical investigative sites, systems, vendors, regulatory submissions. Knowledge: FDA/ICH and country‑specific regulations related to clinical development; SOPs governing clinical research activities. Skills: Problem solving, organization, written and verbal communication, project leadership, conflict resolution, negotiation, independent planning and execution, dynamic prioritization. Other: Strong leadership and networking; open and inclusive environment; ability to work with all levels of the organization. Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified individuals who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act. Compensation & Benefits Base Pay Range: $117,000.00 – $201,250.00. The position is eligible for the Company’s consolidated retirement plan (401(k)), long‑term incentive program, and a range of paid time‑off benefits including vacation, sick time, holiday pay, parental leave, and other standard benefits. Detailed benefits information is available on the Company’s employee‑benefits portal. #J-18808-Ljbffr 6084-Janssen Research & Development, LLC Legal Entity