Director, Audits
vor 6 Monaten
**Passion for Innovation. Compassion for Patients.**:
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For our European office in Zurich, Switzerland we are looking for a
**Director, Audits & Compliance (GCP, GLP, GVP) (M/F/x)**:
**The position**:
This role reporting to the Head, Global Audits & Compliance is accountable for providing leadership to the audit function teams based in Europe with cross collaboration in Latin America and Asia. Oversight of end-to-end audit activities that encompasses systems and processes of Daiichi Sankyo, its partners, affiliates, and vendors. Ensures the coordination and execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections; reporting periodic corrective/preventive actions (CAPA) and effectiveness check metrics and trends to cross-functional departments; improve efficiency, optimize process simplification and lead continuous improvement initiatives at the regional level. Manages audit planning, assignments, support, and reporting of research and development submissions, pre-clinical, Clinical Research (GCP), Pharmacovigilance (PV), Laboratory (GLP) and Global Medical Affairs (GMA) audits/inspections across the organization and affiliates.
**Roles & responsibilities**:
- Audit Program
- Manage and coordinate the audit program for clinical studies, systems and processes, affiliates and vendors in alignment with the Master Audit Schedule. Using a risk-based approach to ensure the Strategic and Tactical Audit Plans (where applicable) are aligned with the company’s strategy and objectives and adjust the plan as needed to support business functions, internal and external stakeholders to execute audits effectively.
- Ensure the auditing program fulfills regulatory requirements, performs external and internal audits, identifies compliance issues and trends, reviews systems and procedures. Support reporting of quality metrics for audits and inspections and execute against these metrics consistently. Ensure trending and signal detection is communicated to stakeholders for risk mitigation.
- Execute and report on high profile audits such as directed audits and fraud investigations to senior management. Support the GCP, GVP and/or GMP/IMP QA teams in identifying and defining quality improvement initiatives for development activities / program.
- Ensure direct reports, qualified by appropriate education and training are assigned to execute the annual audit plan effectively based on their experience and capabilities. Ensure qualification and oversight of audit consultants supporting audit programs.
- Lead and support inspection readiness by preparing direct reports, clinical teams, Clinical Safety and Pharmacovigilance (CSPV) and post marketing stakeholders for key Health Authority pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is archived.
- Support Risk Mitigation programs to ensure compliance to regulatory guidelines
- Corrective and Preventative Action (CAPA) Plans and CAPA Implementation Verification
- Ensure that auditors enter, update and maintain audit CAPA information in the eQMS in a timely manner. Provide compliance oversight metrics and trend analysis of Quality Status to global QA management and to stakeholders of internal and external functions.
- Establish a consistent framework for periodic CAPA updates across the audit team to ensure that the organization is in a perpetual state of compliance.
- Provide management support for direct reports in their assessment of CAPA metrics and CAPA Implementation Verification related to audits. Report metrics to global QA management and to stakeholders of internal and external functions.
- Report on CAPA trends, most frequent or common root causes, CAPA Implementation Verification and areas of improvement in close collaboration with other QA, internal and external stakeholders.
- Strategic Quality Leadership
- Use in-depth knowledge and understanding of applicable regulations, defined processes, quality principles and current business trends to develop and oversee the pre-clinical, GCP, GVP, GLP and GMA Quality audit program execution.
- Conduct activities to suppo
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