Director, Combination Product & Device PQM

Johnson & Johnson

Director leading Quality Engineering for drug-device combination products at Johnson & Johnson. Overseeing compliance, strategy, and team management for Innovative Medicine Quality organization.

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

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Combination Product and Device Development, with a strong focus on regulatory compliance, quality management systems, and lifecycle management. Proven ability to lead multifunctional teams and drive innovative solutions in the pharmaceutical and medical device sectors.

Highest-signal resume keywords

Combination Product DevelopmentRegulatory ComplianceQuality Systems ManagementISO 13485CGMP

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Combination ProductsQuality EngineeringDesign ControlRisk ManagementPharmaceutical ManufacturingMedical Device IndustryRegulatory RequirementsQuality AssuranceTechnical DisciplineLifecycle Management

Tools & Technologies

ISO 14971EN 62366ICH Requirements

Industry Keywords

PharmaceuticalMedical DeviceBiotechQuality ManagementMultifunctional Background

About the role

Key responsibilities & impact

Provide strategic direction for the Johnson & Johnson Innovative Medicine Combination Product & Device Development initiatives
Drive innovative thinking along with a disciplined approach for development, transfer and lifecycle management of new drug device combination products
Take ownership of achieving and maintaining a robust compliance profile for Drug Device Combination Products
Provide functional management to a team of Quality Engineers supporting new product development
Act as a Combination Product & Device Quality Subject Matter Expert
Oversee the revision of site / functional procedures related to Combination Product Development Process & Design Control

Requirements

What you’ll need

Bachelor’s degree in scientific or technical discipline is required
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
Fluent in English

Benefits

Comp & perks

Inclusive work environment
Health insurance
Professional development opportunities