Director, Combination Product & Device Pqm

Johnson & Johnson

Horsham, Pennsylvania, United States of America
Base: $150,000.00 - $258,750.00; bonus/equity: not...
Hybrid
Combination product quality & compliance
Design control procedures
Global health authority inspections
Johnson & Johnson is seeking a Director for Combination Product & Device Product Quality Management (PQM) to provide leadership in Quality Engineering and Quality Assurance for drug-device combination products. The role involves strategic direction, risk management, and regulatory compliance, with a focus on innovation in healthcare solutions

Job Summary

  • The Director, Combination Products & Device, PQM provides Quality Engineering & Quality Assurance leadership for dynamic portfolio of Drug-Device combination products in J&J Innovative Medicine.
  • The scope spans end-to-end product cycle including new product development pipeline and lifecycle management of marketed combination products with emphasis on Design Control & Combination Product Quality Engineering.
  • The anticipated base pay range for this position is : $150,000.00 - $258,750.00

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Director for Combination Product & Device Product Quality Management (PQM) to provide leadership in Quality Engineering and Quality Assurance for drug-device combination products. The role involves strategic direction, risk management, and regulatory compliance, with a focus on innovation in healthcare solutions.

Salary

Base: $150,000.00 - $258,750.00; Bonus/Equity: Not specified; Benefits: Eligible for Company’s consolidated retirement plan (pension) and savings plan (401(k)), long-term incentive program, vacation, sick time, holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Must-have

  • Combination Product Quality & Compliance
  • Design Control Procedures
  • Global Health Authority Inspections
  • Risk Management
  • Quality Systems

Nice-to-have

  • Innovative thinking
  • Disciplined approach
  • Stakeholder management skills
  • Conflict management skills
  • Scientific concepts

Key Requirements

  • Bachelor’s degree in scientific or technical discipline
  • 15+ years of experience in Pharmaceutical, Combination Product and/or Medical Device industry
  • Knowledge of Quality Systems, ISO 13485, ISO 14971, EN 62366, cGMP, and ICH Requirements
  • Knowledge of Devices, Biotech and/or Pharma Manufacturing

Work Rights

Not specified

Tailored Resume

Cover Letter