Director, Combination Product & Device PQM

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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We are searching for the best talent for Director Combination Product & Device Product Quality Management (PQM) to join our Quality organization located in Beerse Belgium; Schaffhausen Switzerland; or Mumbai India.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-068312

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way. Learn more at 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 Director Combination Product & Device PQM works on problems of diverse scope involving the application of global & regional combination product quality and compliance frameworks including 21 CFR Part 4 FDA QMSR EU-MDR etc. The individual serves as a subject matter expert on global Combination Product Quality and Compliance aspects provides quality oversight and guidance training and consultation or medical device and combination products quality systems and quality requirements. The individual is acutely tuned into the external regulatory landscape keep abreast of the latest trends and actively interact with and influences internal and external stakeholders.

Key Responsibilities

• 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 Durg 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.
  

Qualifications

• Bachelors degree in scientific or technical discipline is required. Masters 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.

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