This job has closed.

Johnson & Johnson Innovative Medicine · 4 days ago

Director Product Quality Management

Raritan, NJ

Full-time

Onsite

Director/Executive

$101K/yr - $175K/yr

7+ years exp

Johnson & Johnson is a leader in healthcare innovation, focused on developing solutions for complex diseases. The Director Product Quality Management role involves overseeing the investigation and resolution of product complaints and ensuring compliance with quality standards in the pharmaceutical industry.

Pharmaceuticals

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

Pharmaceutical Industry experienceGXP experienceCGMP regulations knowledgeAnalytical thinkingRisk managementQuality Management SystemsLeadership skillsBudget ManagementCompliance ManagementCorrectivePreventive ActionInternal AuditingISO 9001Policy DevelopmentProcess OptimizationQuality ControlQuality StandardsQuality ValidationStandard Operating ProcedureTactical PlanningTechnical CredibilityMicrosoft Office proficiencyFluent in EnglishMentorship

Required

Requires a BA/BS in Science/Engineering

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