Executive Director Audit and Compliance (Global RD/PV QA)

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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

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.

Summary

This position reports to the Vice President of Quality Assurance and oversees multiple levels of direct reports (Sr Director, Associate Director, Manager) across the global audit function. This individual is a member of the global quality RD/PV QA leadership team. The position may also represent quality in other cross functional leadership teams such as R&D, Safety Board, Corporate Audit and Compliance, etc.

Leads the global and local audit teams across the organization (EU, JP/APAC, Americas and ROW). Provides quality leadership for all R&D, PV, Medical Affairs organizations globally, by ensuring that risk based Good Clinical Practice (GCP), Device and Diagnostics (MDR), Pharmacovigilance (PV), Laboratory audits are conducted, nonconformance and critical compliance risks communicated to senior management, and ensure that risk mitigations, along with corrective and preventative actions are in place. A senior strategic leader within the global quality organization responsible for the preparation, conduct and follow up of Health Authority inspections across disciplines.

This position provides global leadership and audit strategy across the organization in line with the strategic mission and vision of the global quality organization. This role collaborates with R&D quality, PV/MA quality, GMP quality for IMP/ supplier audits as applicable, quality management systems to ensure that activities are conducted in compliance with applicable regulations, GCP regulation, MDR, International Conference and Harmonization (ICH) guidelines, industry standards and internal company processes and procedures. The incumbent will be responsible for developing the global audit universe for the organization and will partner with business leaders across the organization to define and align on strategic priorities and emerging business changes.

Manage global audit resource in an efficient and effective manner including but not limited to oversight of defined work products, coaching and mentoring of global team, performance management and contributing to organizational efficiencies. Ensure quarterly reports which will include audit results/ management actions, corrective actions, progress plans, and proposed quarterly changes are completed and distributed to senior leadership as per pre-defined timelines.

Responsibilities

• Customer Focus:
  • Executes a single and aligned global audit program that is forward looking and supports business growth.
  • Act as management representative for all key health authority inspections (US FDA, EU EMEA, MHRA etc.,). Develop and maintain an effective working relationship with US FDA and other international bodies.
  • Lead/ Collaborate and partner with stakeholders including other quality teams on critical initiatives and transformations.
  • Proactively ensure that all functions consistently operate in a state of compliance.
  • Ensure consistent and standardized execution of the audit framework / methodology across the organization
  • Broaden the traditional quality audit concept beyond the normal routine audits and CAPA generation, evolving it to ensure a quality focus on the services, the experience and knowledge transfer.
  • Ensure the right structure and governance is in place to review audit outcomes through management reviews / audit boards at the GPT or other cross functional levels to drive meaningful customer experience across the portfolio.
• Oversight:
  • Provide strategic direction pertinent to the annual audits and organizational risks stemming from audit and compliance risks not only for internal QA team (global/ local), but also to:
    o Global Medical Affairs
    o Global Project Teams
    o Global Clinical Operations team
    o Clinical Safety and Pharmacovigilance
    o Companion Diagnostics/ Device
    o Vendors/ CROs
• Leadership/ team management:
  • Create a high performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak up
  • Lead and hold others accountable to performance, talent, and development objectives
  • Create an environment that fosters diversity of thoughts, inclusivity and one that adheres to the principals set forth in the organization (JOIN, GROW, THRIVE)
  • Create an environment that thrives on innovation, proactive quality and is disciplined to efficiently execute against pre-defined deliverables
  • Drive employee engagement, mentoring, coaching and performance management
  • Exhibit servant leadership while driving results.

• External Engagement:
  • Contribute, help shape the associated external regulatory environment through participation in industry wide organizations to assure the needs of the company are proactively established and that innovative approach to solutions are in place
  • Continuously review compliance metrics trends from regulators/ industry experts and align develop the audit and compliance road map to meet changing regulatory and business needs. Assure a closed loop of audit outcomes, organizational action plans, remediations and risk management in close collaboration with the organization’s quality management system, to assure robust knowledge transfer and continuous process improvement.
  • Drive effective relationship with alliance partners, collaborators, vendors, and other key company partners to ensure a culture of compliance at all levels
• Strategy:
  • Shape the strategic direction of the global audit function based on the organization’s mid-term plan and beyond.
  • Ensure adequate audit resource are in place and create a strategy for global audit management across regions and geographic areas.
  • Create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization
  • Support the global quality annual objectives, strategic initiatives to deliver against the business plan.

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 required and
• Master's Degree required

Experience Qualifications

• 10 or More Years • Previous experience at a senior management level and demonstrated track record of successful results
  • Significant experience in managing many aspects of quality in an international, global context in a regulated health care environment
  • Experience in Pharmaceuticals, Medical Device, Vaccines, Diagnostics, Generics/ Consumer products required and
• • Strong therapeutic experience specifically Oncology and all other therapeutic experiences preferred. preferred

Travel: Ability to travel up to 20%
 

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.

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.