QMS Champion and Data integrity lead

vor 1 Tag

Nyon, Schweiz Haleon Vollzeit

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

About the role

The purpose of this role is to:

Serving as the main contact with the Global Quality Organization to ensure timely implementation and correct usage of the Haleon Quality System on site.

Acting as the Risk Management Process Owner to establish and maintain the risk identification, documentation, and escalation process in line with global standards.

Collecting, analyzing, and presenting KPIs to the Site Quality Council promptly.

Managing Change Control, Deviation, CAPA, Laboratory Investigation processes, and compliance on site, aligned with HQS.

Assessing Quality Alerts/Bulletins and ensuring timely implementation of associated CAPAs.

Reporting Nyon Site QA operational KPIs to both site and corporate levels.

Leading 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.

Assist in ensuring system and documentation adherence.

Develop DI Quality plan and communication for event prevention and detection.

Quarterly updates to data integrity elements, coordinating system evaluations and CAPAs.

Provide audit support and share best practices.

2. Haleon Quality System Champion:

Ensure site compliance with HQS, communicate QMS information.

Monitor HQS implementation and support inspection readiness.

Participate in HQS Community of Practice.

3. Risk Management Process Owner (RMPO):

Ensure site deployment of Risk Process.

Lead local risk escalation and provide RMS support.

Act as RMS Subject Matter Expert.

4.Quality Systems:

Provide KPIs, ensure process alignment and CAPA implementation.

Coordinate change control process and serve as contact for committee organization.

Qualifications and skills

Essential

Bachelor’s degree or equivalent experience in Quality Science or Engineering.

Minimum 7 years' experience in pharmaceutical industry QA or production.

Strong understanding of GMP regulations, Quality Systems, and manufacturing operations.

Excellent interpersonal and leadership skills.

Safety, Quality, and Results oriented.

Very strong knowledge of GMP and regulatory requirements (e.g., EU GMP, FDA CFR).

Very strong knowledge of Quality Management Systems and Data Integrity management.

Experience in Pharmaceutical/Consumer Goods Manufacturing.

Fluency in French and English.

Good communication skills.

Ability to work in transversal organization and influence key decision makers.

Role model in GxP, HSE, and company values.

Please save a copy of the job description, as this may be helpful to refer to once the advert closes.

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

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