Manager - Audits & Compliance (GCP)

Daiichi Sankyo Europe GmbH; München; Vor Ort; EUR 75.000 - 110.000; Vollzeit

Zusammenfassung

Daiichi Sankyo Europe GmbH is seeking an experienced Audit Lead to manage end-to-end QA audits for Clinical Research and Development, ensuring GCP compliance and effective CAPA management. The role emphasizes risk-based planning, regulatory alignment, and proactive inspection readiness across the organization and affiliates.

Responsibilities include leading audit programs, coordinating mock inspections, tracking CAPA remediation, and guiding stakeholders toward continuous quality improvements in

Qualifikationen

• Bachelor's degree in a scientific, health care or related discipline.
• 5+ years in Quality and clinical development with regulated trials.
• Experience in quality assurance with direct audit exposure preferred.
• Strong knowledge of ICH GCP and regulatory requirements (FDA/EU).

Aufgaben

• Lead end-to-end audit activities for GCP and postmarketing audits.
• Develop risk-based audit plans and manage CAPAs.
• Prepare for Health Authority inspections and mock audits.
• Communicate findings and drive corrective actions with stakeholders.
• Monitor metrics to improve the quality management system.

Kenntnisse

Audit experience

GxP knowledge

ICH GCP Guidelines

Quality assurance

Health Authority inspections

Global experience

Oncology knowledge

QMS tools

Ausbildung

Bachelor's Degree in a scientific field

Tools

eQMS

Power BI

Excel

Jobbeschreibung

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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

• 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.

Responsibilities

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.

• 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)

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.