Job Description

Responsibility for end-to-end audit activities per audit program of GxP relevant audit activities for the Daiichi Sankyo's GxP 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 Developement (GCP) and Global Medical Affairs (GMA) audits/inspections across the organization and affiliates as appropriate for the area of GxP audits assigned.

Roles and Responsibilities:

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Manage and coordinate the audit program for clinical studies and vendors as applicable for the area of GxP audits assigned in alignment with the Master Audit Schedule. Using a risk-based approach to ensure the Audit Plans 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 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. Support the GCP and/or GMP/IMP QA teams in identifying and defining quality improvement initiatives for development activities / program. Support inspection readiness by preparing 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. Ensure up to date 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. Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs.

Personal Skills and Professional Experience:

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Bachelor's Degree in a scientific, health care or related discipline required. 8 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance 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) and company procedures and policies Experience working both independently and as part of a global multifunctional team Ability to review comprehensive audit reports and write summary documentation for senior management and functional areas Proven organizational skills and strong ability to prioritize workload Detail oriented and commitment to seeing tasks through to completion Ability to handle high workloads, stressful situations, and deadlines Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies) International experience is a plus; but at minimum, experience working with diverse cultures and employees Expertise working within early development through Phase III and Pharmacovigilance studies.

Why work with us?

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