Sr. Director of CQA provides Strategic vision and oversight for the Clinical Quality Assurance System including Clinical Standards development and maintenance, Clinical Audit Program, Good Clinical Practice Training and Clinical Inspection Readiness Program. The incumbent will oversee internal quality systems and processes within Clinical and R&D functions to ensure compliance with applicable regulations and requirements; in collaboration with Line Functions or other business process owners, ensure that applicable clinical development, research related processes and quality standards are designed and implemented in line with health authority requirements. Drives the implementation of robust GxP (GCP, CSPV, PV) Quality Management System and Processes for all regulated areas where clinical trial activities are allocated and or executed. Facilitate through proactive and strong leadership; business process excellence to facilitate process simplification and improvement initiatives within the organization. Ability to share/ implement vision and strategy within the responsible line functions as well as globally. Directs globally Clinical processes for improving efficiency by optimizing processes necessary for continuous improvement at the regional and global levels. Together with Management teams, plans, supports conduct and reports Clinical Research and Pharmacovigilance quality assessments at regional level and supports GCP/CSPV/PV inspections across the organization and affiliates.
Develop, Implement and maintain Quality Systems in compliance with applicable regulatory standards (FDA, PMDA, MHRA, ICH, etc.).
Leads project initiatives within the organization. Serves as subject matter expert in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) and act as a contact for internal and/or external stakeholders.
Regulatory Inspections Leadership and accountability: Together with Management teams, plans, supports conduct and reports Clinical Research and Pharmacovigilance quality assessments at regional level and supports GCP/CSPV/PV inspections across the organization and affiliates. Leads the oversight of all GCP, CSPV and PV quality and compliance activities across the organization and ensures strategic alignment for GCP-QA, and in close partnership with other GxP QA functions (GxP Audits, QSP QA team etc.,) ensure proactive communication to the relevant QA GxP teams. Oversight of regulatory inspection preparation, management and follow-up in collaboration with business functions, and support local inspections specifically when IT-systems and / or global clinical operations are in scope. Evaluates and monitors Health Authorities’ interpretation and application of their regulations and guidance, and changes in this interpretation / application over time.
Leads project initiatives within the organization. Serves as subject matter expert in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) and act as a contact for internal and/or external stakeholders
Education: Required Bachelor’s Degree or higher in Life Sciences, Pharmacy or Medicines. PhD in Life Sciences, Pharmacy or Medicines preferred.
Experience:10 or more years of experience in Quality and clinical development in the pharmaceutical industry with involvement in regulated clinical trial PV. Profound knowledge of drug development
Broad understanding of global expectations of Health Authorities.
Thorough and extensive knowledge of ICH- GCP including FDA/PMDA/EU regulations, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice
Demonstrated experience of successfully leading an organization or projects of high impact
Demonstrated leadership and accomplishments in a global/matrix environment
Excellent verbal and written communication skills
Strong interpersonal skills with demonstrated ability to build collaborative relationships
Excellent problem solving and decision-making skills. Skilled at conflict resolution / negotiation.
Strong project management skills
Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world.