Dir, Combination Product & Device PQM
About The Position
The Director, Combination Product & Device, PQM provides Quality Engineering & Quality Assurance leadership for a dynamic portfolio of Drug-Device combination products within J&J Innovative Medicine. The scope spans the end-to-end product cycle, including new product development pipeline and lifecycle management of marketed combination products, with an emphasis on Design Control & Combination Product Quality Engineering. The Director works on problems of diverse scope involving the application of global & regional combination product quality and compliance frameworks, such as 21 CFR Part 4, FDA QMSR, and EU-MDR. The individual serves as a subject matter expert on global Combination Product Quality and Compliance aspects, provides quality oversight and guidance, training, and consultation on medical device and combination products quality systems and quality requirements. The individual is acutely tuned into the external regulatory landscape, stays abreast of the latest trends, and actively interacts with and influences internal and external stakeholders.
Requirements
- Bachelor’s degree in a scientific or technical discipline is required.
- At least 15 years of experience in Pharmaceutical, Combination Product and/or Medical Device industry.
- 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.
Nice To Haves
- Master’s or PhD preferred.
- Multifunctional background preferred.
Responsibilities
- Provide strategic direction for Johnson & Johnson Innovative Medicine Combination Product & Device Development initiatives, ensuring design control procedures are harmonized, integrated, understood, and executed by key business partners across multiple departments and sites.
- Drive innovative thinking with a disciplined approach for the rapid, compliant, high-quality development, transfer, and lifecycle management of new drug-device combination products across multiple sites, ensuring business and regulatory requirements are achieved.
- Take ownership of achieving and maintaining a robust compliance profile for Drug Device Combination Products across JJIM development and supply chain sites, including proactive identification of risks, driving mitigation/remediation activities, and supporting inspection readiness.
- 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.
Benefits
- Inclusive work environment
- Respect for diversity and dignity
- Recognition of merit
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time - 40 hours per calendar year (varies by state)
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
