Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
This role is accountable for providing leadership to audit function based in the US and Europe reporting to the Head, Global Audit & Compliance with a cross collaboration of teams based in, Europe, Asia, and Latin America. Oversight of end-to-end audit activities that encompasses systems and processes of the 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, Clinical Research (GCP) and Global Medical affairs (GMA) audits/inspections at the regional level and provides support across the organization and affiliates.
Responsibilities
Audit Program
• Provide oversight of the Unified Audit Program (UAP), manage and coordinate with the audit program for clinical studies, systems and processes, affiliates and vendors. Using a risk-based approach to ensure the Strategic and Tactical Audit Plans are aligned with the company’s strategy and objectives and adjust the plan supporting 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.
• 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.
• Lead and support inspection readiness by preparing direct reports, clinical teams and Clinical Safety and Pharmacovigilance (CSPV) 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.
Corrective and Preventative Action (CAPA) Plans and CAPA Effectiveness Check
• 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 the effectiveness check system 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, effectiveness checks 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 GCP and GMA Quality audit program execution.
• Conduct activities to support talent management and enhance performance of direct reports to ensure adequate succession planning.
• Collaborate effectively and influence approaches to quality, and ensure alignment with DSG global quality standards, Health Authority regulations, ICH guidelines and other applicable regulatory requirements. Ensure that no delays in the launch of products are due to insufficient QA compliance.
• Participate in forums and through direct interaction with colleagues to escalate concerns and provide expert guidance on GCP compliance issues to support the development and implementation of necessary CAPAs and quality improvement measures.
• Lead improvement initiatives, oversee reporting of audit KPI and ensure continuous improvement opportunities and system/process upgrades are identified and built into the annual objectives/Quality Plan cycle.
Organizational and Personnel Leadership
• Ensure that audit planning and audit assignment of complex/ key projects occurs to meet or exceed business needs by ensuring on-time delivery of the audit program.
• Demonstrates expert level understanding of global expectations of Health Authorities as well as organizational awareness including significant experience working cross-functionally and in global teams across different regions of the world.
• Assist in inspection preparation, support, response coordination, CAPA Plan approval and implementation as well as Effectiveness Checks.
• Support the development and enhancement of the Quality System by leading or participating in quality workshops, authoring and/or reviewing procedures, and conduct of gap analysis.
General Qualifications
Education Qualifications (from an accredited college or university)
Bachelor's Degree in a scientific, health care or related discipline required. A Master's Degree or other advanced degree applicable to pharmaceutical drug development preferred.
Experience Qualifications
Preferred Qualifications
Travel
Ability to travel to/from the office to participate in QA and business function meetings inspections and team activities, etc.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.