Director, GxP Audits
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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.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 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 management support and follow-up post inspection. Ensure that compliance commitments are fulfilled on time.
- Corrective and Preventative Action (CAPA) Plans and CAPA Effectiveness Check
- Responsible for review, track and ensure the completion for CAPA plans provided by vendors as part of monitoring activities for Vendor Qualification Program.
- Establish a consistent framework for monthly and quarterly CAPA updates across the audit team to ensure that the organization is in a perpetual state of compliance.
- Provide management support for direct reports, assessment of the CAPA metrics and its effectiveness, check system related to audits to global QA management and to stakeholders of internal and external functions.
- Take initiatives to report on CAPA trends, common root cause, effectiveness checks and areas of improvement and in close collaboration with other QA, internal and external stakeholders.
- Responsible for updating and maintaining the all GxP audit information to enter in the QMS in a timely manner for overseeing and providing the metrics and trending Quality Status to global QA management and to stakeholders of internal and external functions.
- Collaborate with QA groups and business functions, to provide strategy for regulatory inspection preparation, and align regulatory inspection activities for complex inspection preparation, facilitation, and follow up activities.
- Strategic Quality Leadership
- Applicable GCP, PV and GMA Quality standards/requirements and their implementation supported.
- No delays in the launch of products due to insufficient GxP QA compliance.
- Development, completion, and execution of GxP audit program (Audits, audit reports, corrective and preventive action plans) according to defined process (SOPs) and timelines.
- Issues are adequately and timely escalated.
- Continuous improvement opportunities and system/process upgrades are identified and built into the annual objectives/Quality Plan cycle.
- KPIs related to audits are routinely reported from the line functions consolidated across all regions and reported to the Head, Global GxP Audits.
- Organizational and Personnel Leadership
- Talent management and performance of direct reports and ensure adequate succession planning.
- Ensure that audit planning and audit assignment of complex/ key projects to meet or exceed business needs by ensuring on-time delivery of the audit program
- Providing QA leadership to multiple functions requires a profound understanding of the science, processes, operations, stakeholder management, influence& diplomacy.
- Understanding of global expectations of Health Authorities
- Organizational awareness including significant experience working cross-functionally and in global teams across different regions of the world.
- Bachelor's Degree • Required Bachelor’s Degree or higher in Life Sciences, Pharmacy or Medicines required
- Master's Degree Life Sciences, Pharmacy or Medicines preferred
- PhD PhD in Life Sciences, Pharmacy or Medicines preferred. preferred
- 10 or More Years • No less than 10 or more years of experience in Quality and clinical development in the pharmaceutical industry with involvement in regulated clinical trials/ PV Demonstrated leadership and accomplishments in a global/matrix environment required
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.