Director Product Quality Management

Company Overview 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 Job Function Quality Job Sub Function Multi-Family Quality Job Category Professional All Job Posting Locations Beerse, Antwerp, Belgium, Latina, Italy, Leiden, Netherlands, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Ringiddy, Cork, Ireland, Schaffhausen, Switzerland 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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with 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): Beerse/Antwerp-Belgium, Leiden-Netherlands, Latina-Italy, Cork-Ireland - R- Director Product Quality Management Schaffhausen-Switzerland - R- Director Product Quality Management PA Malvern-USA, Raritan-USA - R- Director Product Quality Management Role Description The Director Product Quality Management Complaint Investigation Manager position will report to the Senior Director of PQM Strategy Deployment & Excellence and is responsible for investigation, documentation and resolution/closure of Product & Signal Complaint Investigations, Nonconformances and/or CAPAs identified through PQV established processes. Responsibilities Act as complaint investigation process SME by providing technical, quality and compliance expertise for investigation, documentation and resolution/closure of Product & Signal Complaint Investigations within the PQM Team. Ensure that deviations & complaints are timely and properly investigated such that the internal and external customer expectations are met. Lead the application and integration of structured root cause problem‑solving methodologies to (Fishbone, 5 Whys, etc.) to all Product & Signal Complaint Investigations identified through PQV established processes. Act as process SME for Nonconformances and/or CAPAs raised as part of Product & Signal Complaint Investigations identified through PQV established processes. Work directly with PQIs/PQOs and device engineers’ teams to ensure product knowledge of Synthetics, Proteins and Cell and Gene therapies are core to all end of end Root Cause Analysis investigations. Work as part of a cross functional Investigation team to drive critical thinking and end-to-end accountability of product and signal complaint investigations. Work with the organization to identify resources to support RCA investigations and resulting actions. Develop and maintain proficiency in the COMET. Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance. Escalate any issues, as needed, to the PQM CAPA Review Board and attend the meetings if required. General Skills Problem solver, who has excellent written and verbal communication skills. Excellent independent time management skills, with a proven ability to plan and track deliverables and timelines. Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business. Highly committed to quality, flexibility and persistence. Good conflict handling/negotiation skills, who’s able to create win‑win situations with internal and external partners. Knowledge of corporate structure and culture. Essential Requirements Requires a BA/BS in Science/Engineering. Master’s degree in life science study or equivalent experience is preferable. Minimum of 7 years’ experience previous Pharmaceutical Industry experience is required, with at least 7 years of GXP experience within clinical research and development and/or quality assurance. Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation, legislation related to cGMP regulations (Eudralex, ICH, Ph.Eur., USP, etc) at global, regional and national levels. Strong analytical thinking, decision-making and leadership skills. Excellent verbal and written communication skills to negotiate and communicate with customers and partners. Able to apply appropriate risk assessment strategies to manage business & compliance priorities and translate them into actionable items and an action plan. Fluent in English. Proficient in Microsoft Office applications. In the Netherlands the anticipated base pay range for this position is 101,000.00 to 174,800.00 on an annual basis and includes 8% holiday allowance. At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time. Interview Process Application review: We’ll carefully review your CV to see how your skills and experience align with the role. Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have. Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step. Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these. Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process Preferred Skills Budget Management Compliance Management Corrective and Preventive Action (CAPA) Creating Purpose Internal Auditing ISO 9001 Mentorship Policy Development Process Optimization Quality Control (QC) Quality Management Systems (QMS) Quality Standards Quality Validation Risk Management Standard Operating Procedure (SOP) Tactical Planning Technical Credibility #J-18808-Ljbffr