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Quality Management & Lab Systems Lead

Organon

Organon

Quality Assurance
Lisbon, Portugal
Posted on Sep 27, 2025

Job Description

The Organon Quality Management & Lab (QML) Systems Team Lead is responsible for the operation, support, delivery, and enhancement of Organon’s IT systems for the Quality Business Unit. This role requires managing core Quality Management processes and Lab Information Systems, including Customer Complaints, Deviations, Change Control, Document Management, Risk Management, Audits, LIMS, Empower, and ELN.

Leading the QML team involves defining and executing a joint IT and Business strategy related to Quality Systems. This includes ensuring compliance, Computer Systems Validation, and Data Integrity across technologies and processes. As part of the Manufacturing & Supply Business Technology Services team, the role requires defining and executing the QML systems strategy in close partnership with various resources and management levels on the business side.

The role also involves navigating constraints like resources, cost, timing, and regulatory factors to implement, support, and maintain necessary IT systems. Leading the global QML Value Team, the individual supports all Organon quality functions globally. This position requires strong leadership skills to effectively manage these responsibilities.

Key Responsibilities

  • Lead the global QML Value Team, supporting all Organon quality functions.

  • Establish and manage the integrated QMS and QML Value Team to ensure consistent operational support and service delivery.

  • Develop and implement the QML IT strategy in partnership with functional stakeholders, aligned with global Quality goals.

  • Oversee the current QML systems portfolio and define short- and long-term roadmaps.

  • Collaborate with business partners to ensure IT solutions meet strategic and operational needs.

  • Manage software vendors and internal/external resources to deliver value-driven projects.

  • Ensure compliance with SDLC standards, Computer Systems Validation, and Data Integrity requirements.

  • Drive continuous improvement and support team development across IT and business areas.

Qualifications & Experience

  • Bachelor’s degree in IT, Science, Business, or a related field; postgraduate qualifications (e.g. MBA, MSc) preferred.

  • Demonstrable experience in IT management, with a focus on delivering strategic solutions and system support.

  • In-depth knowledge of Quality Management processes including Complaints, Deviations, Change Control, Document Management, Risk Management, and Audits.

  • Practical experience with Laboratory Information Systems such as LIMS, Empower, and ELN.

  • Proven ability to deliver both foundational and innovative IT solutions across business domains.

  • Strong understanding of regulatory frameworks and compliance standards.

  • Excellent communication, stakeholder engagement, and influencing skills.

  • Sound financial and business acumen, with experience managing budgets and project timelines.

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R536026