QA Compliance Lead (m/f/d)

Reposted 14 Hours Ago
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Stein AG, Aargau, CHE
In-Office
Expert/Leader
Artificial Intelligence • HR Tech • Information Technology • Social Impact
The Role
Lead the Quality Assurance Compliance activities, ensuring GMP compliance and preparation for audits and inspections. Develop QMS and govern risk management processes.
Summary Generated by Built In
Company Description

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach 296 million people worldwide. We want to create an inclusive workplace where every one of us can be our best and true selves, so that together we can discover more, reach underserved communities and reimagine medicine.
Company Name: Novartis

Job Description

Summary
Location: Stein, Switzerland
We are seeking a highly senior Quality Assurance Compliance leader to safeguard and continuously strengthen our GMP compliance landscape in Switzerland. This role is designed for an experienced quality authority who brings deep regulatory credibility, strategic oversight, and confident leadership in complex, regulated environments.

About the Role

Key responsibilities:

  • Provide overall leadership and strategic oversight of Quality Compliance activities across the site in line with cGxP requirements
  • Act as the senior quality authority for audits, inspections, and health authority interactions, ensuring sustained inspection readiness
  • Own and continuously develop the Quality Management System (QMS), including deviations, CAPAs, change control, and data integrity
  • Lead and govern GxP risk management, incident management, and compliance remediation activities
  • Ensure effective regulatory and quality oversight of site activities, suppliers, and service providers
  • Drive a strong quality culture, serving as a role model for integrity, accountability, and patient focus
  • Partner closely with senior stakeholders across Manufacturing, Technical Operations, Regulatory, and Global Quality
  • Coach and develop senior quality professionals, ensuring sustainable expertise and succession within the organization
  • Champion Lean Leadership and operational excellence initiatives.

Essential Requirements:

  • Minimum 15 years of progressive experience in Quality Assurance and Compliance within a GMP‑regulated pharmaceutical or biotech environment
  • Proven track record in senior QA leadership roles, with clear accountability for compliance strategy and inspection outcomes
  • Deep expertise in cGMP, Quality Systems, and regulatory frameworks (EMA, FDA, Swissmedic)
  • Extensive experience leading health authority inspections, audits, and complex remediation programs
  • Strong credibility and executive presence when interacting with senior internal and external stakeholders
  • Demonstrated ability to lead, influence, and challenge at senior management level
  • University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline
  • Fluent in English; German is a strong advantage for Switzerland

Benefits & Rewards

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

Applicable Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

QualityOperationsSwitzerland
Job ID
REQ-10074385
QA Compliance Lead (m/f/d) Apply to Job

Skills Required

  • 15 years of progressive experience in Quality Assurance and Compliance
  • Experience within a GMP-regulated pharmaceutical or biotech environment
  • University degree in Life Sciences, Pharmacy, Chemistry or related discipline
  • Fluency in English; German is an advantage
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The Company
100 Employees
Year Founded: 2020

What We Do

Jobs for Humanity connects historically underrepresented talent, including persons with disabilities, refugees, and immigrants, with welcoming employers. They leverage AI to streamline the hiring process, aiming to create a fairer future for all.

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