Director, Audits & Compliance (GCP, GLP, GVP)

Director, Audits & Compliance (GCP, GLP, GVP)

Daiichi Sankyo Europe

Zurich, Switzerland

The position:

This role reporting to the Head, Global Audits & Compliance is accountable for providing leadership to the audit function teams based in Europe with cross collaboration in Latin America and Asia. Oversight of end-to-end audit activities that encompasses systems and processes of 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, pre-clinical, Clinical Research (GCP), Pharmacovigilance (PV), Laboratory (GLP) and Global Medical Affairs (GMA) audits/inspections across the organization and affiliates.

Roles & responsibilities:

Audit Program

  • Manage and coordinate the audit program for clinical studies, systems and processes, affiliates and vendors in alignment with the Master Audit Schedule. Using a risk-based approach to ensure the Strategic and Tactical Audit Plans (where applicable) are aligned with the company’s strategy and objectives and adjust the plan as needed to support 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. Ensure trending and signal detection is communicated to stakeholders for risk mitigation;
  • 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. Ensure qualification and oversight of audit consultants supporting audit programs;
  • Lead and support inspection readiness by preparing direct reports, clinical teams, Clinical Safety and Pharmacovigilance (CSPV) and post marketing stakeholders 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;
  • Support Risk Mitigation programs to ensure compliance to regulatory guidelines;
  • Corrective and Preventative Action (CAPA) Plans and CAPA Implementation Verification;
  • 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 CAPA Implementation Verification 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, CAPA Implementation Verification 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 pre-clinical, GCP, GVP, GLP 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 GxP 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 CAPA Implementation Verification;
  • 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.

Professionel experience & education:

General Qualifications

  • Experience working both independently and as part of a global multifunctional team;
  • Ability to review comprehensive audit reports and write summary documentation for senior management and functional areas;
  • Proven organizational skills and strong ability to prioritize workload;
  • Detail oriented and commitment to seeing tasks through to completion;
  • Ability to handle high workloads, stressful situations, and deadlines;
  • 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

  • 10 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance. Demonstrated leadership and accomplishments in a global/matrix environment, or equivalent experience;
  • Proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials. Ability to provide interpretation and guidance for internal and external customers on GxP related regulations/guidelines (e.g., FDA, EU, ICH) and company procedures and policies;
  • For GVP, proficiency in GVP Modules and regulatory requirements for pharmacovigilance and post-marketing safety;
  • REMS and Risk Mitigation regulatory experience preferred.

Preferred Qualifications

  • Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products;
  • Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies);
  • International experience is a plus; but at minimum, experience working with diverse cultures and employees;
  • Expertise working within early development through Phase III and Pharmacovigilance studies. preferred.

Travel

  • Ability to travel to/from the office to participate in QA and business function meetings inspections and team activities, etc.

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