Job Description
The position
The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.
The incumbent also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g. small molecules, therapeutic proteins, biologics, vaccines, devices, combination products, sterile product, excipients, active pharmaceutical ingredients, intermediates, seeds and cell banks) through direct oversight, support and technical advice, counseling to site leadership, and on-site supervision. The AD may serve as a subject matter expert for EQA and Division in specific Quality systems,



technology platforms, regulatory expectations and/or EE management, and can represent the Company in forums on their area of expertise (both internal & external).
Responsibilities
May manage a team of Quality Assurance professions as direct reports. Holds regular 1-on-1 meetings and Employee Development Plan discussions.
Accountable for executing the performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports, when applicable.
Contributes to development of the EQA budget and tracks and controls expenses as needed to meet EQA budget.
Exhibits our company Leadership Behaviors and provides a leadership example for the team.
Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (

📌 External Quality, Associate Director (Madrid)
🏢 Organon
📍 Madrid