QA Compliance Lead (m/f/d)

Novartis Pharma Schweiz AG seeks a Senior QA Compliance Lead in Stein Aargau, CH, to oversee Quality Compliance activities, lead audits, and ensure cGxP adherence across site operations.

The company is looking for a senior professional to provide strategic oversight of Quality Compliance activities across its site, ensuring alignment with cGxP standards. This role serves as the primary quality authority for audits, inspections, and interactions with health authorities, maintaining continuous inspection readiness.

Responsibilities

• Manage and evolve the Quality Management System, covering deviations, corrective actions, change control, and data integrity.
• Direct GxP risk management, incident handling, and compliance remediation efforts.
• Oversee regulatory and quality standards for site operations, suppliers, and service providers.
• Foster a quality-driven culture by modeling integrity, accountability, and patient-centric values.
• Collaborate with senior leaders in Manufacturing, Technical Operations, Regulatory, and Global Quality.
• Mentor and develop senior quality staff to build sustainable expertise and succession plans.
• Promote Lean Leadership and operational excellence across the organization.

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 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 at the senior management level.
• University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field.
• Fluent proficiency in English.

Nice to have

• German language skills are a strong advantage for the Switzerland location.

What the company offers

• Novartis is dedicated to creating an outstanding, inclusive work environment with diverse teams that reflect the patients and communities served.
• The workplace is designed to be accessible and inclusive for all employees.
• Employees can access a handbook detailing various ways the company supports personal and professional growth.

About the company

Novartis Pharma Schweiz AG is committed to fostering an outstanding, inclusive work environment. The company builds diverse teams that reflect the patients and communities it serves, ensuring an accessible and supportive workplace for all employees.

• Commitment to an outstanding, inclusive work environment.
• Diverse teams representative of patients and communities.
• Accessible and inclusive workplace.