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Executive Director, Quality Management System Global RD/PV QA

Job Description
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

The Executive Director, Quality Management System RD/PV QA position reports to the Vice President of Quality Assurance and oversees multiple levels of direct reports (Sr Director, Associate Director, Manager) across the global QMS function located in EU, JP/APAC and Americas. This individual is a member of the global quality RD/PV QA leadership team and DSI QA leadership team. The position may also represent quality in other cross-functional leadership teams such as Global IT governance board, Dx organization, R&D, LMS executive committee, and Corporate Compliance.

This position is accountable to drive harmonization and standardization of the Daichi Sankyo Quality Management System (QMS) in Global R&D, CSPV and Medical Affairs, including SOP and Training processes. Interface and collaborate with all levels of the organizations, including GMP QA and QA teams across regions. Maintain knowledge with current industry trends, Health Authority expectations and influence standards accordingly to incorporate into business processes.

Define/introduce and implement improvements to existing tools and operationalize new systems in support of overall process excellence in Global QA. This position provides global leadership and QMS strategy across the enterprise in line with the strategic mission and vision of the global quality organization. This role collaborates with R&D quality, PV/MA quality and GMP quality for quality management systems to ensure that activities are conducted in compliance with applicable regulations, GCP, GVP, GLP, MDR, International Conference and Harmonization (ICH) guidelines, industry standards and internal company processes and procedures. The incumbent will be responsible for developing the global QMS for the pharmaceutical development, Medical Affairs and Pharmacovigilance organizations and will partner with business leaders across the organization to define and align on strategic priorities and emerging business changes.

The role will manage global QMS resources 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.

Responsibilities

  • Customer Focus:
    • Develop a best-in-class Quality Management strategy for Daiichi Sankyo business functions across the GxPs.
      o Lead/ Collaborate and partner with cross functional leaders across the company to drive standardization of Quality Systems.
      o Proactively ensure that all functions consistently operate in a state of compliance.
      o Establish the Quality Planning and Quality Objectives process ensuring an effective monitoring and escalation process along with establishing programs to effectively monitor and assess the global quality system through metrics and scorecards.
      o Define the process for alignment and collaboration of QMS related actions with other functions whenever needed.
      o Develop the strategical direction for quality and compliance training needs and recommend/ participate in the development of respective training platform and their delivery.
      o Establish QMS LT, QMSC and other boards and/ or teams/ committees related to QMS topics.
      o Lead/ establish a harmonized/ standardized processes within cross functions through key established governance (i.e.., QMS Steering Committee) to avoid conflict of procedures and processes within the functions.
    • Lead/ Collaborate and partner with stakeholders including other quality teams on critical initiatives and transformations.
    • Act as management representative for all key health authority inspections (US FDA, EU EMEA, MHRA etc.,), specifically where QMS is in question. Develop and maintain an effective working relationship with US FDA and other international bodies.
    • Ensure end to end compliance cycle SOP-Training- Metrics/Trending- Lessons learned to drive meaningful customer experience across the enterprise.
  • Oversight:
    Provide strategic direction pertinent to the Systems, Processes, Procedures for internal QA team (global/ local), but also to:
    • Global Medical Affairs
    • Global Project Teams
    • Global Clinical Operations team
    • Clinical Safety and Pharmacovigilance
    • Companion Diagnostics/ Device
    • Vendors/ CROs
    Establish a globally deployed IT solution(s) related to areas of responsibility to include but not limited to:
    • CAPA
    • Management Reviews
    • Non-conformances
    • Quality Systems Review, Quality Planning, and Quality Objectives
    • Analytics and Quality Scorecard
    • Change Control- in collaboration with GMP QA
    • Data and Document Management
    • Records Management
    • Computer Systems Validation
    • Training Management
    • Lead/ Establish the creation, review of all relevant Quality Manual documents (Modules and Daiichi Sankyo Wide SOPs).
    • Provide consolidated comments from GQA and DS stakeholders, and advocate for simplified defined processes and procedures.
    • Establish key governance and lead the oversight of the overall Quality Management System within Daiichi Sankyo.
    • Define specific QMS needs and QMS strategy along with R&D, CSPV, MA, GQA management and RD/PV QA LT]
    • Establish a continuous review process to assess, revise as necessary RD/PV QA QMS.
    • Ensure Implementation of Daiichi Sankyo quality standards and policy (including quality manual and developed modules, DS SOPs as applicable) in R&D, CSPV and MA, including related monitoring and reporting processes.
    • Ensure a functional quality team is in place responsible to establish cross functional review process along with SMEs (i.e., SOPs, SOIs) for up-to-date reviews of such GxP documents, its robustness and fit for purpose.
  • 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 QMS road map to meet changing regulatory and business needs. Lead remediations and risk management to assure the organization's quality management system is robust and ensure knowledge transfer and continuous process improvement in collaboration with other QA functions.
    • 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 Management System based on the organization's mid-term plan and beyond.
    • Ensure adequate resource are in place and create a strategy for global QMS across regions and geographic areas.
    • Effectively manage budget close to 2-3 million USD on strategic projects.
    • 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 leading a QMS organization and demonstrated track record of successful results required and
  • Significant experience in managing many aspects of quality in an international, global context in a regulated health care environment required and
  • Experience in Pharmaceuticals, Medical Device, Vaccines, Diagnostics, Generics/ Consumer products, required and
  • Strong expertise in process engineering, continuous improvement, change management, and evolving the capabilities of an organization required and
  • Experience working directly with global Health Authorities (FDA, EMA, MHRA) and other government and local agencies required and
  • Working knowledge of the end-to-end Drug development process (manufacturing to commercialization required



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.

Executive Director, Quality Management System Global RD/PV QA

Bernards, NJ
Full Time

Published on 05/02/2022

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