Individual contributor is accountable for ensuring that all Company products managed by EQA are manufactured, packaged, tested, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements.

Responsibilities

- Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
- Evaluate and release products according to procedure, ensuring that goods are manufactured in conformance with company policies and regulations; review and approve changes to master batch records or laboratory methods/specifications.
- Ensure metrics are compiled, analyzed and reported, identifying trends and root causes to drive process improvements.
- Oversee external entity (EE) sites involved in product release, ensuring they meet company and regulatory standards.
- Act as Qualified Person under EU GMP Annex 16 for batch certification and release, confirming compliance with Marketing Authorization, Good Manufacturing Practice, and all regulatory requirements.
- Accountable for Quality Control functions, including oversight of product testing, batch documentation review, and deviation investigations as applicable.
- Operate in a safe and efficient manner in compliance with the Safety and Health Policy.
- Travel up to 25% of the time,



occasionally on short notice.

Qualifications

- Education: Minimum four‑year degree in Science, Engineering or other relevant technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent).
- Minimum of 5 years’ relevant experience in the pharmaceutical and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control, integral GMP and regulatory requirements.
- Strong interpersonal, communication, coaching, motivation, negotiation and persuasion skills to build strong relationships.
- Ability to work across boundaries with demonstrated relationship‑building and leadership skills.
- Fluent in English, both verbally and in writing.
- University degree and/or relevant experience for placement in an EU QP licensee.
- Previous experience in a site Quality and Qualified Person role/function preferred.
- Moderate level of contractual and financial awareness.
- Previous experience participating in regulatory inspections.
- Familiarity with all domestic and foreign regulations and compendia governing plant operations.

At Organon Spain we have a current local Equity Plan that ensures equal treatment and opportunities for all our employees and candidates.

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📌 Senior Specialist, External Quality Assurance (EQA) (Madrid)
🏢 Organon España
📍 Madrid