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 15,000 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.ROLE SUMMARY
This role is accountable for planning, conducting and managing internal and external GVP qualification, routine and for cause (directed) audits, primarily based in the US, reporting to the Head, Global Audits & Compliance
. Ideal candidate will have a strong PV background combined with expert audit experience.
- Will engage in cross collaboration with teams based in Europe, Asia, and Latin America to provide oversight of end-to-end audit activities as per the approved audit program encompassing systems and processes of the Daiichi Sankyo pharmacovigilance business function, its License Partners, Affiliates, and Vendors.
- Conducts timely and accurate risk assessments to ensures the coordination and execution of a risk-based GVP audit program.
- Plans, supports, conduct and reports Pharmacovigilance (GVP) and Medical Affairs and REMS program audits and inspections at the regional level and provides support across the global organization and to Affiliates.
- Serves as a member of Global QA (GQA) participating in and leading GVP audits process improvement initiatives.
- This position is responsible for facilitating and communicating CAPA status within QA as well as to cross-functional departments and management and ensures that the CAPA metrics and trending are being reported consistently.
- Supports corrective action and preventive action (CAPA) management due to findings and observations resulting from audits, health authority inspections, quality events or deviations. Assess and conduct effectiveness checks of CAPA to prevent recurrence.
- Interpret relevant regulations to aid Clinical Safety, Post-Marketing Safety, Medical Affairs, Commercial PV QA and other departments to apply them in a practical way to ensure compliance of programs for novel products to all regulatory requirements for the protection of human subjects and patients.
- Member of Global QA (GQA) ensuring local and global conformance with regulatory requirements, internal GVP compliance standards. Serve as SME and support inspection preparedness of Clinical Safety and Pharmacovigilance teams for key Health Authority and support verification that compliance commitments are fulfilled on time.
- Supports proactive integration of quality through SOP development and process improvement activities.
- Contribute to setting the annual GVP audit schedule, including resource demand and budget in support of the Audit Program in support of a comprehensive risk-based GVP compliant quality program Plan, schedule, conduct and report internal and external GVP Audits according to an agreed Audit Program to provide assurance that regulatory, documentation and record-keeping requirements are met internally as well as externally at Sponsor Sites, Vendors, Service Providers, Affiliates and License Partners and in support of REMS programs.
- Develop and manage aspects of Sponsor Site, License Partner, Affiliates and Vendor audit program and conduct robust risk assessments to assure that all are appropriately qualified.
- Ensure that all assigned audits are completed as required by the Audit Program and in compliance with applicable GQA procedures.
- Document audit conduct, findings, CAPA, effectiveness checks, track / verify implementation of CAPA commitments, effectiveness checks and evidence of supporting documentation. and archive within the electronic quality management system in a timely manner.
- Escalate critical findings from audits and inspection to QA and functional department leadership.
- Review and approve audit finding responses; evaluate and approve corrective and preventative action (CAPA) and associated implementation timelines.
- Provide oversight to GVP audits conducted by third parties, review and approve associated audit reports and ensure they are entered in the electronic quality management system. Provide high quality audit reports and trends to system and/or process owners.
- Manage GVP audit metrics, tracking of audits and inspections CAPA status for reporting in the Quarterly Quality Reports and QA Councils and Quality Review Boards.
- Track ongoing / planned audit activities and provide summary reports to QA management.
- Support all aspects of GVP regulatory inspections including preparation, conduct, coordinating responses, evaluating supporting documentation, tracking and verification of CAPA commitment implementation, and effectiveness checks, are completed.
- Support global Health Authority inspections as SME and during Inspection Preparedness activities
- Engage in ongoing communications with DS QA across global locations, QA Outsourcing Providers, and Consultants.
- Provide coaching and mentoring to junior level staff members.
- Create or review and revise QA SOPs to ensure that they are current, adhere to global laws, regulations, guidance documents and Daiichi-Sankyo standards.
: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.General Qualifications
- Experience working both independently and as part of a global multifunctional team
- Ability to write comprehensive audit reports and 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
(from an accredited college or university)
- Must have a Bachelor's Degree in a scientific, health care or related discipline and/or background in medical health Profession (RN, Medical technologist).
- A Master's Degree or other advanced degree applicable to pharmaceutical drug development is highly preferred.
- 7+ years of professional Quality Assurance experience with a world-class quality organization in the Pharmaceutical/CRO industry, including 3+ years of direct Pharmacovigilance / GVP compliance auditing.
- 7+ years of first-hand knowledge of drug development
- Demonstrated knowledge of PSMF audit-related information
- Proficiency with computerized systems used for audit and inspection management (e.g., Trackwise), Documentation management (e.g., Veeva Vault) and safety reporting management (e.g., eTMF, EDC, Argus, Aris G, IVRS) and MS Excel.
- 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)
- Experience with trending of GVP findings and CAPAs
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
- Ability to travel up to 40% both domestic and international (to/from the office to participate in internal audits, inspections and team activities). Travel includes site, License Partner, Affiliates, Vendor compliance audits.
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.