The Position:

LOCATION: Germany or Switzerland

Responsibility for end-to-end audit activities of RDPV QA relevant audit activities for the Daiichi Sankyo Group and its partners as applicable. Ensures the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections; manages audit planning, assignments, support, and reporting of Clinical Research and Development (GCP) and Postmarketing audits/inspections across the organization and affiliates as appropriate for the area of audits assigned.

Roles and Responsibilities:

Manage and coordinate the audit program for clinical studies and vendors, as applicable, within the assigned RDPVQA audit areas, in alignment with the Master Audit Schedule by:

• Applying a risk-based approach to ensure Audit Plans are aligned with company strategy, objectives, and regulatory requirements.
• Maintaining and adjusting Audit Plans, as needed, to support evolving business priorities and internal and external stakeholder needs.
• Effectively planning, coordinating, and executing audits to ensure the audit program meets applicable regulatory and quality requirements.
• Performing audits to assess compliance with GxP and company standards, identifying compliance issues, systemic gaps, and emerging trends.
• Communicating audit outcomes and recommendations to stakeholders and supporting the implementation and monitoring of corrective and preventive actions (CAPAs).
• Monitoring audit metrics and trends to drive continuous improvement and strengthen the effectiveness of the quality management system.

Ensure that responses to audit findings and Corrective and Preventive Action (CAPA) plans:

• Adequately address identified issues, observations, and non-compliances.
• Appropriate root cause analysis and sustainable corrective actions to prevent recurrence are reviewed, approved, and entered the eQMS in a timely manner.
• CAPA activities and effectiveness checks are completed within agreed timelines.
• Collaborate with the QMS team and relevant Quality and DS functional area representatives.
• Monitor CAPA progress and ensure timely completion of actions.
• Escalate risks, delays, and overdue activities as appropriate.
• Ensure there are no overdue CAPAs and that effectiveness checks are completed as required.

In collaboration with A and C Leadership team, DM Quality team and relevant business stakeholders support continuous improvement initiatives by identifying trends and opportunities for enhanced compliance and quality system effectiveness.

Support inspection readiness by preparing Clinical Teams, Clinical Safety and Pharmacovigilance (CSPV), and post-marketing stakeholders for Health Authority, pre-approval, sponsor, monitor, and site inspections. Plan and conduct mock inspections to assess readiness, identify compliance gaps, and support continuous improvement. Provide inspection management support and post-inspection follow-up, ensuring regulatory commitments are fulfilled on time and supporting evidence is appropriately documented and archived. Key responsibilities:

• Coach stakeholders and facilitate mock inspector interviews to enhance inspection preparedness.
• Identify and track remediation of gaps and findings from mock and regulatory inspections.
• Coordinate inspection logistics, communications, and document requests.
• Support inspection activities and timely responses during inspections.
• Monitor inspection commitments and CAPAs to ensure timely completion and compliance.
• Ensure inspection-related documentation and evidence are maintained and archived in accordance with company and regulatory requirements.

Personal Skills and Professional Experience:

• University Degree Bachelor's Degree in a scientific, health care or related discipline required.
• 5 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance
• Experience in quality assurance with direct audit experience is highly preferred
• Proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials. Ability to provide interpretation and guidance for internal and external customers on GxP related regulations / guidelines (e.g., FDA, EU, ICH E6) and company procedures and policies.
• International Global experience including EU and Japan preferred.
• Proven experience with Health Authority Inspections, (e.g., EMA, FDA, HPFB, MHRA and other European regulatory agencies).
• Professional or other related functions and familiarity with Oncology, Companion Diagnostic products and early development preferred.
• Familiarity with QMS system and reporting tools and systems (e.g., eQMS, Power BI, Excel)