Johnson & JohnsonRemote
Director Product Quality Management
United States of America
Full Time
3 weeks ago
$150,000 - $259,000 USD
H1B Sponsor Likely
Key skills
Pharmaceutical industry experienceGXP regulationsClinical researchdevelopmentQuality assurancePharmaceutical legislationcGMP regulationsRisk assessmentMicrosoft OfficeCorrectivePreventive Action (CAPA)Internal auditingISO 9001Quality Management Systems (QMS)Quality controlQuality standardsQuality validationRisk managementStandard Operating Procedure (SOP)Process optimizationBudget managementPolicy developmentConflict handlingLeadershipRisk ManagementCommunicationCritical Thinking
About this role
Johnson & Johnson is a leader in healthcare innovation, committed to developing smarter and less invasive treatments. The Director Product Quality Management will oversee complaint investigations, ensuring compliance and effective resolution of product complaints while collaborating with cross-functional teams to drive quality improvements.
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
- 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