Director, Combination Product & Device PQM

Role Overview

• 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

• 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.
• 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
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year