Director, Combination Product & Device PQM

Johnson & Johnson

Director of Quality Engineering for Combination Products leading a team at Johnson & Johnson. Overseeing drug-device combination product compliance and process management.

Posted 7/14/2026full-timeBeerse • 🇧🇪 BelgiumLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced knowledge in Combination Product Development, Quality Systems, and regulatory compliance, with a strong focus on stakeholder management and project leadership. Proficient in risk management and technical writing, ensuring high-quality standards in drug-device combination products.

Highest-signal resume keywords

Combination Product DevelopmentQuality Systems ManagementRegulatory Compliance (FDA, EMA, ISO 13485)Project ManagementStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Combination ProductsDesign ControlRisk ManagementQuantitative AnalysisStatisticsCGMPTechnical WritingSOP DevelopmentDoEQuality Engineering

Soft Skills

Strong Communication SkillsDecision-Making SkillsConflict ManagementFacilitation SkillsLeadership

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryBiotech ManufacturingISO 14971EN 62366ICH RequirementsInspection ReadinessCompliance ProfileLifecycle ManagementAsset Evaluation

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Inclusive work environment where each person is considered as an individual