Director, Product Quality Management
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Malvern • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $258,750 per year
Job Level
Lead
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
root cause analysisFishbone5 WhysCAPAnonconformance monitoringGXPcGMP regulationspharmaceutical legislationclinical researchquality assurance
Soft skills
analytical thinkingdecision-makingleadershipcommunicationcritical thinkingnegotiationaccountabilityrisk assessmentproblem-solvingcollaboration