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At Johnson & Johnson, we believe health is everything.
Our expertise in Innovative Medicine and Med Tech empowers us to innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.
Visionaries work on teams that save lives by developing the medicines of tomorrow.
Role Overview
The Director Product Quality Management Complaint Investigation Manager reports to the Senior Director of PQM Strategy Deployment & Excellence.
The role 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 to meet internal and external customer expectations.
Lead the application and integration of structured root cause problem‑solving methodologies (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.
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‑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 actively drive compliance.
Escalate any issues as needed to the PQM CAPA Review Board and attend the 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 and respond to changing needs of the business.
Highly committed to quality, flexibility, and persistence.
Good conflict handling/negotiation skills to create win‑win situations with internal and external partners.
Knowledge of corporate structure and culture.
Essential Requirements
BA/BS in Science/Engineering; Master's degree in life science study or equivalent experience is preferred.
Minimum 7 years of previous Pharmaceutical Industry experience, 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, c GMP 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.
What You Can Expect from the Hiring 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.
Feedback: 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.
Required and 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.
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