Johnson & Johnson · 1 month ago
Director Product Quality Management
Raritan, New Jersey, United States of America
Full-time
Hybrid
Director/Executive
$101K/yr - $175K/yr
7+ years expJohnson & Johnson is a leader in healthcare innovation, focused on developing treatments and cures for complex diseases. The Director Product Quality Management will oversee complaint investigations and ensure compliance with quality standards, leading a team to resolve product and signal complaints effectively.
Hospital & Health Care
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
Qualification
Required
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
Preferred
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
Benefits
8% holiday allowance
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase