Associate Director, QA GxP

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.

THIS ROLE REQUIRES EXPERTISE IN GxP/GVP. Note this is NOT a GMP role.

Summary

· Manage the Service Provider, Systems and Process Audit Program within Pharmacovigilance QA space to assure that all are in an acceptable state of compliance

· Assure that all studies performed by Daiichi- Sankyo Group (DSG) R&D and Medical Affairs (MA) are in compliance with GVP requirements and can withstand scrutiny from regulators in all countries where we study and register our products.

· Manage metrics and the implementation tracking of corrective and preventive actions in follow-up to audits and inspections.

· Work with the DS QA groups based in the EU, Japan, US regions, and other functional departments to develop and implement QA objectives and audit schedules to include development related PV audit universe.

· Member of Global QA (GQA) participating and representing GQA in Global QA group leading joint audits and global SOP development.

· Assure that Daiichi Sankyo QA is a full partner in development activities and that world class development standards are applied wherever we do business.

· Liaise and consult with Early and Late Product Strategy development teams, Pharmacovigilance, Operational and Technical Services and others to ensure local and global conformance with regulatory requirements, GVP, internal standards, and to provide proactive integration of quality and process improvement.

· Interpret relevant regulations and aid R&D, Clinical Safety and Pharmacovigilance, and other departments to apply them in a practical way to ensure compliance of clinical development programs for novel products as well as to all regulatory requirements for the protection of human subjects.

· Ensure fraud resilient data collection, and apply systematic approaches to detect and assess potential fraud.

· Support quality documentation and quality system implementation programs.

Responsibilities

- Manage assigned aspects of a fully functional PV audit program for DSI Phase I through IV clinical development studies, and supporting Discovery phase QA activity where necessary.
- Plan, schedule, conduct and report Internal and External PV Audits according to an agreed Unified Audit Plan to provide assurance that QA’s regulatory, documentation and record-keeping requirements are met internally as well as externally at PV vendors, affiliates and license partners.
- Engage in ongoing communications with global DS QA locations, QA Outsourcing Providers, and Consultants.
- Provide coaching and mentoring to junior level staff members.
- Document audit conduct, findings, CAPA, effectiveness checks, supporting documentation, tracking / verification of CAPA commitment implementation, and effectiveness checks are conducted within the electronic quality management systems in a timely manner.
- Escalate critical findings from audits and inspection to QA and functional department leadership.
- Provide oversight to audits conducted by third parties and ensure they are entered in the electronic quality management system.
- Support all aspects of PV regulatory inspections at partner and sponsor facility including preparation, conduct, coordinating responses, evaluating supporting documentation, tracking and verification of CAPA commitment implementation, and effectiveness checks, are completed.
- Develop and manage vendor and service provider audit program and conduct risk assessments to assure that all service providers are appropriately qualified.
- Manage audit metrics, CAPA tracking of audits and inspections including Quarterly Quality Reports for distribution to the Global QA group.
- Create and review Quality Assurance SOPs and policies to ensure that they are current, adhere to laws, regulations, guidance documents and Daiichi-Sankyo standards.

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, health care or related discipline and/or background in medical health Profession (RN, Medical technologist, etc.) required or a Master's Degree or other advanced degree preferred

Experience Qualifications

Proven expertise in successful conduct of PV Audits is required as well as in supporting PV inspections including CAPA management through to implantation and effectiveness check

Ability to successfully provide global strategic and tactical leadership to customers to achieve DSG goals in alignment with DSG core values and behaviors

7+ years of professional Quality Assurance experience with a world-class quality organization in the Pharmaceutical/CRO industry. In particular, working as an internal QA consultant to development teams or equivalent experience required.

7+ years of first-hand knowledge of drug development working in the capacity of GVP Compliance

Preferred Qualifications

Professional or other related function and familiarity with Oncology, specialty medicines and Companion Diagnostic products preferred

Proven experience dealing with Health Authorities, (e.g., FDA, HPFB, MHRA and other European regulatory agencies) preferred

Demonstrated experience with Regulatory Agency Inspection support and/or management. Preferred

Knowledge of the impact of regulatory bodies on drug development. preferred

International experience is a plus; but at minimum, experiences working with diverse cultures and employees preferred

Expertise working within early development through Phase III and Pharmacovigilance studies. preferred

Travel

Ability to travel up to 40% In-house office position that may require travel (global).

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.