Manager GCP/Document Audits

Join a Legacy of Innovation – 125 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 18,000 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 Audits & Compliance, GCP/Document Audits supports end-to-end audit activities per audit program of GxP relevant audit activities for the Daiichi Sankyo's GxP group and its partners as applicable ensuring the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections across the organization and affiliates as appropriate for the area of GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common Technical Document submission.

Responsibilities

• Support audit program for clinical studies and vendors as applicable for the area of GxP audits assigned in alignment with the Master Audit Schedule, using a risk-based approach to ensure the Audit Plans 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.
• Support inspection readiness by preparing 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.
• Ensure up to date audit CAPA information in the eQMS in a timely manner.
• Support CAPA completion for all outsourced audits with Development and Medical QA, PV QA, QMS and stakeholders.
• Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs.
• Conduct document audits including, but not limited to Common Technical Document (CTD), Clinical Study Report (CSR) and Nonclinical Study Report (NCR), electronic Trial Master File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application

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 in a scientific, healthcare or related discipline required

Experience Qualifications

• Must have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document review
• Must have at least 4 or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials and creation of regulatory submission documentation with the 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.
• International experience including EU and Japan preferred
• Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products preferred
• Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies) preferred
• Expertise working within early development through Phase III and Pharmacovigilance studies preferred
• Medical, technical writing experience a plus

Travel Ability

Must have the ability to travel up to 25-30% domestic and international.

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.

Salary Range: