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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.
Job Function: QualityJob Sub Function: Multi-Family QualityJob Category: Professional
All Job Posting Locations: Beerse, Antwerp, Belgium; Latina, Italy; Leiden, Netherlands; Malvern, Pennsylvania, USA; Raritan, New Jersey, USA; 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.
The Role: Director of Product Quality Management – Complaint Investigation Manager
The Director of Product Quality Management 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 and Impact
Act as a 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 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 (e.g., Fishbone, 5 Whys) to all Product & Signal Complaint Investigations identified through PQV processes.
Serve as a process SME for Nonconformances and/or CAPAs raised as part of Product & Signal Complaint Investigations.
Work directly with PQIs/PQOs and device engineering teams to ensure product knowledge of Synthetics, Proteins and Cell and Gene therapies is core to all end‑to‑end Root Cause Analysis investigations.
Collaborate with a cross‑functional Investigation team to drive critical thinking and end‑to‑end accountability of product and signal complaint investigations.
Identify resources with the organization to support RCA investigations and resulting actions.
Develop and maintain proficiency in the COMET.
Monitor nonconformance and CAPA deliverables/timelines for the 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 meetings if required.
General Skills
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/respond to changing business needs.
Highly committed to quality, flexible and persistent.
Good conflict‑handling/negotiation skills, able to create win‑win situations with internal and external partners.
Knowledge of corporate structure and culture.
Qualifications
BA/BS in Science/Engineering; Master’s degree in life science or equivalent experience preferred.
Minimum of 7 years in the Pharmaceutical Industry, 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, including 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 annually, inclusive of 8% holiday allowance.
Recruitment Process & Expectations
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 our recruitment team to learn more about you and answer any questions.
Staying informed: We keep you updated throughout the process and ensure you know what to expect at each step.
Final steps: Successful candidates will complete country‑specific checks before starting. We’ll guide you through these.
After completion: We’ll invite you to complete a short survey to share feedback and help us improve the hiring experience.
Required & Preferred Skills
Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), 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.
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