Director, GVP Quality Assurance

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.

Job Summary This role is accountable for providing leadership to audit function primarily based in the US reporting to the Head, Global GxP audits with a cross collaboration of teams based in, Europe, Asia, and Latin America. Oversight of end to end audit activities per audit program of GxP relevant audit activities that encompasses the systems and processes of the Daiichi Sankyo's GxP group and 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, non- compliance and incidence or deviations. This position establishes framework for monthly corrective/preventive actions (CAPA) updates across the GxP Audit team to ensure that the organization is in perpetual state of regulatory compliance. Additionally, this position is responsible for facilitating the CAPA effectiveness program and communicating CAPA status to cross-functional departments and management and ensures that the CAPA metrics and trending are being reported consistently.

Ability to implement proactive Global GxP Audit vision and strategy within the responsible line function as well as improving efficiency by optimizing process simplification and continuous improvement initiatives at the regional and global levels. Together with Regional DSI Management teams, plans, supports, conduct and reports pre-clinical, Clinical Research (GCP), Pharmacovigilance (PV) and Global Medical affairs (GMA) audits/inspections at regional level and support across the organization and affiliates.

Responsibilities Leadership/Audit Program Provide proper oversight of the GxP Audit Program to contribute to the DSG business priorities and strengthen and renew in accordance to the changes in the clinical landscape.

Manage and coordinate with the audit program for all types of audits in the audit program of clinical studies that encompasses the systems and processes of the Daiichi Sankyo’s GxP group and its affiliates and vendors.

Ensure the Annual Audit Plans are fully aligned with the company’s strategy and objectives and adjust the plan using a risk-based approach which would support business functions, internal and external stakeholders to execute audits effectively.

Ensure direct reports are qualified and assigned to execute the annual audit plan effectively in the team based on the experience and capabilities.

Lead the GxP compliance auditing program to fulfill regulatory requirements, including and not limited to, performing internal audits and identification of compliance issues and trends, review of systems and procedures with appropriate education and training.

Support quality metrics for audits and inspections and execute against these metrics consistently.

Execute and report to senior management on high profile audits such as directed audits and fraud investigations.

Support the GCP/PV and or GMP/IMP QA teams in identifying and defining quality improvement initiatives for development activities/ program.

Lead and support inspection readiness by preparing clinical teams and CSPV for FDA/EU/key HA pre-approval and sponsor-monitor inspections; provide inspection…