Director, GVP Quality Assurance

Job Summary

Responsibilities

• 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.

• 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.

• 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.

Responsibilities Continued

• 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.

Qualifications

Education Qualifications

Bachelor's Degree in Life Sciences, Pharmacy or Medicines required. A Master's Degree or other advanced degree preferred

Experience Qualifications
10 or more years 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, or equivalent experience required 

Travel Requirements
Ability to travel up to 30% of the time. Domestic, International