Hybrid Director, Product Quality Management

at Johnson & Johnson

• Job title: Director, Product Quality Management
• Job type: Full Time
• Experience level: Lead
• Salary: $258,750 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Malvern, United States

About the role

• Director of Product Quality Management at Johnson & Johnson. Leading investigation and resolution in product quality management and compliant 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.

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
• 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.

Benefits

• Health insurance
• 401(k) matching
• Flexible work hours
• Professional development opportunities