Johnson & Johnson

Director, Combination Product & Device PQM

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Titusville • New Jersey • Pennsylvania • United States

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Salary

💰 $150,000 - $258,750 per year

Job Level

Lead

About the role

  • Provide strategic direction for the Johnson & Johnson Innovative Medicine Combination Product & Device Development initiatives while ensuring design control procedures are harmonized, integrated, understood & executed by key business partners across multiple departments and sites.
  • Drive innovative thinking along with a disciplined approach for the rapid, compliant, high-quality development, transfer and lifecycle management of new drug device combination products across multiple sites while ensuring business and regulatory requirements are achieved.
  • Take ownership of achieving and maintaining a robust compliance profile for Drug Device Combination Products across the JJIM development and supply chain sites. This includes proactive identification of risks, driving mitigation/remediation activities and supporting inspection readiness activities.
  • Provide functional management to a team of Quality Engineers supporting new product development and lifecycle management of drug-device combination products.
  • Act as a Combination Product & Device Quality Subject Matter Expert in global Health Authority inspections.
  • Oversee the revision of site / functional procedures related to Combination Product Development Process & Design Control and provide training programs in the area of Combination Products.
  • Act as a Qualified Trainer for the deployment of these and any other applicable training programs.
  • Develop and apply advanced knowledge of advanced quantitative analysis, statistics, DoE etc.
  • Support asset evaluation for licensing and acquisitions activity.
  • Carry out duties in compliance with all local, state, and federal and international regulations and guidelines including FDA, EMA, EPA, OSHA, and global health authorities as applicable.

Requirements

  • Bachelor’s degree in scientific or technical discipline is required.
  • Master’s or PhD preferred
  • At least 15 years of experience in Pharmaceutical, Combination Product and/or Medical Device industry.
  • Multifunctional background preferred
  • Deep understanding of Combination products and associated regulatory and quality requirements
  • Understanding of business & technical needs and can relate these to scientific concepts
  • Experience with Quality Systems, ISO 13485, ISO 14971, EN 62366, cGMP, and ICH Requirements
  • Knowledge of Devices, Biotech and/or Pharma Manufacturing required, particularly in Design Controls and Risk Management
  • Demonstrated strong stakeholder management skills
  • Prior leadership of and participation in projects across functions & sites
  • Strong Project Management and Communication Skills
  • Strong Decision-making skills: Makes decisions independently on problems and methods.
  • Excellent technical writing skills; experienced in SOPs, protocols, reports.
  • Conflict Management and facilitation skills required.
  • Fluent in English
  • Ability to write routine technical & quality documents and correspondence or procedures using original, prescribed, or innovative techniques or styles.
  • Ability to speak, present and/or respond before groups of customers, employees, Regulatory agencies, clients, and to address common inquiries.
Benefits
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • This position is eligible to participate in the Company’s long-term incentive program.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
combination productsdesign controlquality systemsISO 13485ISO 14971EN 62366cGMPICH requirementsquantitative analysisrisk management
Soft Skills
stakeholder managementproject managementcommunication skillsdecision-makingtechnical writingconflict managementfacilitation skillsleadershipinnovative thinkingtraining