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Manager, Clinical Quality Management, Inspection Readiness Lead, Global Clinical Operations

3 months ago

Atlanta, United States Daiichi Sankyo Full time

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 16,000 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

The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for representing the GCO-CQM inspection readiness within the Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure continued inspection readiness and/or preparation, and to highlight potential business process improvement and identify strategic solutions for improvement where needed. The CQM IRL is expected to consistently support the process for gathering, analyzing and sharing of best practices and lessons learned. This role will also work with R&D Quality Assurance (R&D QA) and the respective operational functions to identify areas for improvement from audits, IR / preparation activities, inspection outcomes and investigational panels and identifies the appropriate next steps for strategic process update and/or information sharing.

Responsibilities:

GCP Compliance:

  • Develop seamless partnerships within GCO and non-GCO functions to ensure SMTs are performing according to necessary ICH/GCP-relevant regulatory requirements and global, departmental and geographical SOPs, policies and guidelines and that the teams are implementing best practices to help facilitate the inspection readiness mindset.
  • Facilitates clinical quality risk identification and the necessary problem solving and corrective measures relevant to inspection readiness.
  • Support the inspection preparation team pre-, during and post- regulatory agency sponsor inspection with the goal to ensure GCO/clinical teams are prepared and trained and study documentation is quality controlled and available, and all can withstand the scrutiny and questioning of a sponsor pre-approval inspection.
  • Post inspection, audit, quality review, investigational panel or other identified sources, gather, analyze, prepare and present on lessons learned / best practices to the GCO platform and other key stakeholders, in collaboration with RD QA or other relevant stakeholders. Work in a mindset of being a learning organization.

Strategic Planning and Oversight:

  • Support strategies to work with GCO and cross-functional departments to build ‘inspection readiness’, identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study reporting.
  • Build appropriate interfaces with cross functional departments and participates in cross-departmental best practice working groups for process development / optimization.
  • Ensure administrative documents (CVs,JDs, etc) for GCO departments and required for inspection readiness, are maintained, updated and readily available for inspections.

Process Improvement:

  • Support the development of Inspection Readiness Plans and metrics with respective functional team leaders and applicable Co-Development Partners and CROs.
  • Analyze and identify opportunities for optimization, define appropriate key Performance Indicators and follow-up their correct implementation towards developing a business governance, framework and culture of operational excellence.

Metrics and Collaboration Opportunities:

  • Support the clinical teams to generate metrics and dashboards for status of inspection readiness reporting elements to management monthly or as needed. Continuously monitor and identify and implement improvements to the process.
  • Support development of inspection readiness related training for GCO and cross-functional subject matter experts.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)

  • Bachelor's Degree Bachelor's degree with minimum of 3-5 years' experience in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance. required Experience Qualifications
  • 4 or More Years Strong knowledge of ICH-GCP relating to regulatory guidelines, and quality management principles. required
  • Expert knowledge in Clinical Operations Phase 1 to 4 Trial Execution. required
  • Oncology trial execution experience. preferred
  • Demonstrated critical thinking and problem-solving ability. required
  • Quality mindset and prior quality experience preferred required
  • Strong collaboration, interpersonal, oral, and written technical communication skills. required
  • Strong project management skills and ability to influence other without direct authority required
  • Experience with SOPs and working in a regulated environment preferred
  • Metric experience preferred
  • Understanding and experience with end-to-end clinical trial processes and functions including experience in one or more clinical trial operations functions / sub-functions (Data Management, Biostatistics, Clinical Science) preferred

Travel:

  • Ability to travel up to 5% For team/global meetings, conferences and to support inspections.

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.