QMS Champion and Data integrity lead, Nyon

vor 1 Tag

Nyon, Schweiz TN Switzerland Vollzeit
QMS Champion and Data Integrity Lead, NyonClient:

Haleon

Location:

Nyon

Job Category:

Other

Job Reference:

d9f3949511e6

Job Views:

8

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

Hello. We’re Haleon. A new world-leading consumer health company. Together, we’re improving everyday health for billions of people.

This is an exciting time to join us and help shape the future.

About the Role

The purpose of this role is to:

  1. Serve as the main contact with the Global Quality Organization to ensure timely implementation and correct usage of the Haleon Quality System on site.
  2. Act as the Risk Management Process Owner to establish and maintain the risk identification, documentation, and escalation process in line with global standards.
  3. Collect, analyze, and present KPIs to the Site Quality Council promptly.
  4. Manage Change Control, Deviation, CAPA, Laboratory Investigation processes, and compliance on site, aligned with HQS.
  5. Assess Quality Alerts/Bulletins and ensure timely implementation of associated CAPAs.
  6. Report Nyon Site QA operational KPIs to both site and corporate levels.
  7. Lead the implementation of data integrity strategy, ensuring compliance with regulatory requirements for data management across all GxP categories.

Key Responsibilities

  1. Data Integrity Champion: Lead QMS and regulatory compliance for data integrity, including monitoring at Site level.
  2. Haleon Quality System Champion: Ensure site compliance with HQS, communicate QMS information.
  3. Risk Management Process Owner (RMPO): Ensure site deployment of Risk Process.
  4. Quality Systems: Provide KPIs, ensure process alignment and CAPA implementation.

Qualifications and Skills

  1. Bachelor’s degree or equivalent experience in Quality Science or Engineering.
  2. Minimum 7 years' experience in pharmaceutical industry QA or production.
  3. Strong understanding of GMP regulations, Quality Systems, and manufacturing operations.
  4. Excellent interpersonal and leadership skills.
  5. Safety, Quality, and Results oriented.
  6. Very strong knowledge of GMP and regulatory requirements (e.g., EU GMP, FDA CFR).
  7. Very strong knowledge of Quality Management Systems and Data Integrity management.
  8. Experience in Pharmaceutical/Consumer Goods Manufacturing.
  9. Fluency in French and English.
  10. Ability to work in transversal organization and influence key decision makers.
  11. Role model in GxP, HSE, and company values.

Diversity, Equity and Inclusion

At Haleon, we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives and promotes fair and equitable outcomes for everyone.

Care to join us. Find out what life at Haleon is really like at www.haleon.com/careers/

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