Manager, Clinical QA Program Lead

Johnson & Johnson seeks a Manager, Clinical QA Program Lead in Allschwil, Switzerland, to drive clinical quality audit strategies and ensure GCP compliance across therapeutic programs.

This position sits within the Clinical Quality function and is responsible for leading domain-specific compliance audit programs. The role focuses on developing and executing audit strategies, managing GCP audits, and providing expert guidance on complex quality and regulatory matters to ensure adherence to global standards.

Responsibilities

• Design and implement tactical audit plans that align with domain-specific strategies for therapeutic programs, clinical systems, or suppliers.
• Independently manage the full lifecycle of QA audits, including planning, execution, and reporting.
• Conduct GCP audits and support GxP audits, dedicating up to half of working time to these activities.
• Analyze audit outcome trends to identify proactive collaboration opportunities with stakeholders for resolving compliance issues.
• Provide expert-level advice and guidance on complex quality and compliance challenges, maintaining deep knowledge of GCP standards.
• Guide auditors in defining scope, planning, conducting, and reporting on audits.
• Prepare and review audit summary reports to escalate significant findings to senior leadership.
• Translate risk management strategies into actionable audit plans and scopes by reviewing risk profiles.
• Support business partners and auditors in developing and approving Corrective and Preventive Actions (CAPAs).
• Serve as the main point of contact for Clinical QA activities related to Health Authority inspections.
• Lead key project initiatives and teams across the organization.
• Utilize data analytics tools to examine data sources and identify trends for audit program development.

Requirements

• Bachelor’s degree or equivalent university qualification.
• Minimum of five years of experience in a compliance field or a related R&D area within a GxP-regulated discipline.
• Proven experience in conducting GCP audits.
• Demonstrated ability to develop audit strategies and capabilities for therapeutic programs, GCP systems, or supplier audits.
• Ability to work onsite at the Allschwil location three days per week.

About the company

Johnson & Johnson operates with the belief that health is paramount, striving to create a world where complex diseases are prevented, treated, and cured. The organization fosters an inclusive environment that values each individual, respecting employee diversity and dignity while recognizing merit.

• Commitment to preventing, treating, and curing complex diseases.
• Inclusive work environment that treats every person as an individual.
• Respect for employee diversity, dignity, and merit.