[Hiring] Associate Director, Qualified Person, Europe @Revolution Medicines

Role Description

The Qualified Person (QP) holds ultimate responsibility for the certification and release of medicinal products in accordance with EU GMP, Directive 2001/83/EC, Dutch pharmaceutical legislation, and applicable Marketing Authorisations.

• Provides independent, authoritative quality leadership across site operations.
• Serves as a key member of the site leadership team, ensuring patient safety, product quality, regulatory compliance, and reliable supply.
• Provides strategic oversight of the Pharmaceutical Quality System.
• Partners closely with senior stakeholders across Quality, Technical Operations, Supply Chain, and Regulatory Affairs.
• Represents the site in interactions with Health Authorities.

Qualifications

• Master's degree in Pharmacy, Chemistry, Biotechnology, or relevant scientific discipline.
• 9+ years experience working in quality related roles with increasing responsibility.
• Eligibility for registration as a Qualified Person under Dutch pharmaceutical legislation.
• Extensive experience as a Qualified Person with direct batch release accountability.
• Deep working knowledge of EU GMP and relevant regulatory frameworks.
• Proven inspection experience and senior stakeholder engagement capability.
• Fluency in English; Dutch language skills are an advantage.
• Risk-based, pragmatic mindset balancing compliance and supply reliability.

Requirements

• Act as the legally registered Qualified Person with full authority for certification and release of clinical and commercial medicinal products.
• Ensure batch certification in compliance with EU GMP, Directive 2001/83/EC, national legislation, EU GMP Annex 16, and applicable Marketing Authorisation.
• Exercise independent decision-making authority, including batch rejection and escalation when required.
• Ensure timely batch disposition aligned with supply commitments and compliance requirements.
• Responsible for the certification and release of Investigational Medicinal Products (IMPs) in accordance with EU Clinical Trial Regulation and EU GMP Annex 13.
• Maintain QP oversight of the end-to-end GMP supply chain.
• Provide oversight of the Pharmaceutical Quality System, ensuring inspection readiness and regulatory alignment.
• Oversee deviations, CAPAs, change controls, investigations, complaints, and recalls.
• Approve critical GMP documentation including SOPs, validation documentation, and quality agreements.
• Ensure that third-country manufacturing sites comply with EU GMP requirements.
• Provide QP oversight of data integrity governance across GMP processes and computerized systems.
• Oversee continued process and product verification activities.
• Act as a strategic quality partner to site and functional leadership.
• Lead quality risk assessments related to manufacturing operations and change initiatives.
• Mentor QA professionals and support QP succession and capability building.
• Serve as primary QP representative during inspections and Health Authority interactions.
• Define and present quality KPIs, trends, and risk assessments to senior management.
• Drive continuous improvement using data-driven insights and benchmarking.
• Maintain an effective interface with Pharmacovigilance to ensure timely assessment and escalation of quality-related safety signals.

Benefits

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