Provide Quality Engineering & Quality Assurance leadership for combination products
Ensure design control procedures are harmonized and executed
Drive rapid and compliant development of drug-device combination products
Identify risks and support inspection readiness activities
Functional management to Quality Engineers supporting product development
Act as a Subject Matter Expert in global Health Authority inspections
Develop and provide training programs in the area of Combination Products

Bachelor’s degree in scientific or technical discipline 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
Strong stakeholder management skills
Strong Project Management and Communication Skills
Excellent technical writing skills; experienced in SOPs, protocols, reports
Fluent in English

Director, Combination Product & Device PQM

Key skills