Dir, Combination Product & Device PQM

About the role

The Director, Combination Product & Device, Product Quality Management (PQM) role is available across multiple countries including Belgium, Switzerland, and India. This role provides Quality Engineering & Quality Assurance leadership for a dynamic portfolio of Drug-Device combination products in J&J Innovative Medicine. The scope spans the entire product cycle, including new product development pipeline and lifecycle management of marketed combination products with a focus on Design Control & Combination Product Quality Engineering.

Responsibilities

• Provide strategic direction for Johnson & Johnson Innovative Medicine Combination Product & Device Development initiatives while ensuring design control procedures are harmonized, integrated, understood, and 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, including 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.
• 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.
• Fully fluent in English.

Qualifications

• 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.
• 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.
• Fully fluent in English.