Senior GVP QA Auditor & Compliance Lead

Organon LLC; Lisboa; On-site; EUR 120,000 - 180,000; Full time

Job summary

Organon seeks an Associate Director, GVP Quality Assurance Auditor in Lisbon to ensure quality and regulatory compliance across Organon processes, affiliates, vendors and business partners. You will lead audits, guide internal stakeholders, and help shape the company's compliance strategy while mitigating risks.

The role requires a Pharm/Life Sciences background, 10+ years in pharma QA or regulatory, and deep knowledge of EMA/FDA/ICH guidance.

Qualifications

• Bachelor’s degree in a relevant scientific field.
• Fluency in written and spoken English; additional language skills a plus.
• Minimum of ten (10) years of experience in pharma QA/regulatory.
• Minimum of one (1) year of experience in GVP auditing.

Responsibilities

• Schedule and conduct GVP audits per global plan, ensuring regulatory compliance.
• Prepare audit reports and manage follow-up activities within established timelines.
• Maintain awareness of evolving regulatory trends and Organon policies.
• Provide guidance to internal stakeholders and communicate audit issues to all levels.
• Train and mentor junior team members.

Skills

English fluency

GVP auditing experience

Regulatory guidelines knowledge

Communication skills

Project management

Leadership skills

Education

Bachelor’s degree in a scientific field

Tools

Microsoft Office

Job description

Organon seeks an Associate Director, GVP Quality Assurance Auditor in Lisbon to ensure quality and regulatory compliance across Organon processes, affiliates, vendors and business partners. You will lead audits, guide internal stakeholders, and help shape the company's compliance strategy while mitigating risks.

The role requires a Pharm/Life Sciences background, 10+ years in pharma QA or regulatory, and deep knowledge of EMA/FDA/ICH guidance.