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 https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All Job Posting Locations:** Leiden, Netherlands, Warsaw, Masovian, Poland **Job Description:** **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 We are searching for the best talent for a **Senior RA Professional, Submissions, CAPAs** . This hybrid work position will be located in Leiden, the Netherlands or Warsaw, Poland. Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). + High Wycombe, United Kingdom - Requisition Number: **R-036049** + Raritan, USA; Titusville, USA - Requisition Number: **R-036051** **​** Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The CAPA Lead is a strategic role within the Next Gen Submissions (NGS) function, responsible for driving quality, compliance, and continuous improvement across the regulatory submissions lifecycle and publishing lifecycle. This role ensures that CAPA activities are executed in compliance with applicable regulatory requirements, company policies, and industry best practices. The CAPA Champion acts as a subject matter expert, coach, and facilitator—supporting cross-functional teams to identify root causes, implement robust corrective/preventive measures, and verify long-term effectiveness. **Main Duties and Responsibilities:** ~50% of time: **CAPA Oversight** + Serve as the Next Gen Submissions lead for the CAPA process, ensuring timely initiation, investigation, implementation, and closure of Non-Conformances and CAPAs. + Monitor CAPA progress, provide guidance on documentation quality, and ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, ISO standards). + Maintain CAPA metrics and dashboards to drive transparency and accountability. **Root Cause Analysis & Quality Improvements** + Facilitate structured root cause investigations using recognized methodologies (e.g., 5 Whys, Fishbone, FMEA). + Partner with stakeholders to design effective corrective and preventive actions that address systemic issues and reduce recurrence. + Evaluate CAPA effectiveness and recommend adjustments where necessary. ~40% of time: **Process Improvement & Governance** + Identify opportunities for improving CAPA workflows, tools, and templates. + Contribute to the development and maintenance of CAPA-related SOPs, policies, and work instructions. + Identify automation and process simplification opportunities to optimize submission processes. + Champion best practices and standardization across Next Gen Submissions. + Support Knowledge Management activities including maintenance knowledge management technology platform and regulatory submission processes documentation. ~10% of time: **Training & Coaching** + Act as a CAPA process subject matter expert (SME), providing training, mentoring, and coaching to Next Gen Submissions employees. + Promote a culture of continuous improvement and proactive issue resolution. **Qualifications** **Required** + University/Bachelor’s degree or equivalent experience and generally 6 years of pharmaceutical industry or related experience. + 2 years in regulatory affairs/operations or quality systems + Root Cause Analysis methodologies + CAPA systems, Regulatory Document Management **Preferred** + Masters/Pharm D/PhD with 1-3 years’ experience + 3–5+ years in regulatory operations or GxP environment + Lean Six Sigma Black Belt