Hybrid Director, Product Quality Management

at Johnson & Johnson

• Job title: Director, Product Quality Management
• Job type: Full Time
• Experience level: Lead
• Salary: €101,000 - €174,800 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Latina, Italy

About the role

• Director of Product Quality Management leading complaint investigations and ensuring compliance within the PQM Team. Responsible for technical expertise and compliance in the pharmaceutical sector.

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.

Requirements

• Requires a BA/BS in Science/Engineering.
• Master’s degree in life science study or equivalent experience is preferrable.
• 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.