Director Product Quality Management

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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 Med Tech, 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.

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Quality

Multi-Family Quality

Beerse, Antwerp, Belgium;
Latina, Italy;
Leiden, Netherlands;
Malvern, Pennsylvania, United States of America;
Raritan, New Jersey, United States of America;
Ringaskiddy, Cork, Ireland;
Schaffhausen, Switzerland

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‑050019 Director Product Quality Management
• [Schaffhausen‑Switzerland] – R‑050939 Director Product Quality Management
• [PA Malvern‑USA, Raritan‑USA] – R‑050955 Director Product Quality Management

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.

• 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 so that internal and external customer expectations are met.
• Lead the application and integration of structured root cause problem‑solving methodologies (Fishbone, 5 Whys, etc.) to all investigations identified through PQV established processes.
• Act as process SME for Nonconformances and/or CAPAs raised as part of investigations identified through PQV established processes.
• Work directly with PQI/PQO and device engineer teams to ensure product knowledge of Synthetics, Proteins and Cell and Gene therapies are core to all end‑to‑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 drive compliance.
• Escalate any issues, as needed, to the PQM CAPA Review Board and attend the meetings if required.

• Problem solver with 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 prioritize and respond to changing business needs.
• Highly committed to quality, flexibility and persistence.
• Good conflict handling/negotiation…