Senior Lead Auditor for Compliance Assurance

Vor 6 Tagen

Zürich, Zürich, Schweiz Daiichi Sankyo Europe Vollzeit

About Daiichi Sankyo Europe

Daiichi Sankyo is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that enrich the quality of life around the world. With over 120 years of experience and more than 17,000 employees in over 20 countries, we are committed to addressing the needs of patients with cardiovascular disease and cancer.

We have a global presence with affiliates in 13 European countries and Canada. Our European headquarters are located in Munich, Germany. As a Senior Manager PV Audits, you will be responsible for supporting all aspects of pharmacovigilance audits and regulatory inspections to ensure compliance with laws, regulations, and guidelines.

Job Description

The Senior Manager, GvP Audits is a key role that reports to the Head of Global Audits and Compliance. This position involves planning, scheduling, conducting, and reporting pharmacovigilance audits to ensure all stakeholders are in an acceptable state of compliance. The role requires strong analytical and communication skills to document audit findings, track CAPA implementation, and escalate critical issues to QA leadership.

Key Responsibilities

  • Plan, schedule, and conduct pharmacovigilance audits, including service providers, systems, processes, license partners, and affiliates
  • Document audit findings, CAPA, and supporting documentation in electronic quality management systems
  • Support regulatory inspections, including preparation, coordination, response evaluation, tracking, and verification of CAPA commitment implementation
  • Evaluate the effectiveness of CAPA and escalating critical findings to QA and functional department leadership
  • Develop and manage Quality Assurance SOPs and policies to ensure compliance with laws, regulations, and guidelines
  • Liaise with Cross-Functional teams (CSPV) to ensure local and global conformance with regulatory requirements and internal standards

Requirements and Qualifications

To be successful in this role, you should have a Bachelor's Degree in a scientific or related discipline and/or background in Medical health Profession (RN, Medical technologist, etc.). You must also have at least 7 years of Quality Assurance experience with a world-class quality organization in the Pharmaceutical/CRO industry.

A minimum of 7 years' experience in First-hand knowledge of GVP Compliance Professional or other related function and familiarity with Oncology, Specialty Medicines, and Companion Diagnostic products is required. Experience of direct dealings with Health Authorities, such as FDA, HPFB, MHRA, and other European regulatory agencies, is essential.

In addition, you should have international experience, preferably working with diverse cultures and employees. A proactive mindset, passion for addressing patient needs, and commitment to quality are essential qualities for success in this role.

Why Work with Us?

At Daiichi Sankyo, we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. We offer opportunities for growth, innovation, and collaboration. If you are passionate about making a difference in patients' lives and want to contribute your ideas, we invite you to apply for this exciting opportunity.

Salary

The estimated salary for this role is approximately €80,000 - €110,000 per annum, depending on qualifications and experience.

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