QA Compliance Lead (m/f/d)

Novartis seeks a Senior QA Compliance Lead in Stein Aargau to oversee GMP compliance, lead audits, and strengthen quality culture across Swiss operations.

This senior position provides strategic oversight of quality compliance activities at the Swiss site, ensuring sustained inspection readiness and robust regulatory adherence. The role serves as the primary quality authority for interactions with health authorities and drives continuous improvement in quality systems and operational excellence.

Responsibilities

• Direct strategic oversight of all Quality Compliance activities at the site, aligning with cGxP standards.
• Serve as the lead quality authority for audits, regulatory inspections, and communications with health agencies, maintaining constant inspection readiness.
• Manage and evolve the Quality Management System, covering deviations, corrective actions, change control, and data integrity protocols.
• Govern GxP risk management, handle incident response, and oversee compliance remediation efforts.
• Provide regulatory and quality supervision for site operations, external suppliers, and service providers.
• Foster a robust quality culture by modeling integrity, accountability, and a focus on patient safety.
• Collaborate with senior leaders in Manufacturing, Technical Operations, Regulatory Affairs, and Global Quality.
• Mentor and develop senior quality staff to build sustainable expertise and ensure leadership succession.
• Promote Lean Leadership principles and drive operational excellence initiatives.

Requirements

• At least 15 years of progressive experience in Quality Assurance and Compliance within GMP-regulated pharmaceutical or biotech settings.
• Demonstrated success in senior QA leadership positions, with clear responsibility for compliance strategy and inspection results.
• Extensive knowledge of cGMP, Quality Systems, and regulatory frameworks including EMA, FDA, and Swissmedic.
• Proven experience leading health authority inspections, audits, and complex remediation programs.
• Strong executive presence and credibility when engaging with senior internal and external stakeholders.
• Ability to lead, influence, and challenge senior management effectively.
• University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field.
• Fluent proficiency in English.

Nice to have

• Proficiency in German is highly advantageous for the Switzerland location.

About the company

Novartis fosters an inclusive and diverse work environment that reflects the patients and communities it serves. The company culture emphasizes collaboration, mutual support, and inspiration to achieve breakthroughs that improve patients' lives.

• Commitment to building an outstanding, inclusive work environment.
• Diverse teams representative of patients and communities.
• Collaborative culture focused on supporting and inspiring each other.
• Mission-driven approach to achieving breakthroughs that change patients' lives.