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Director, Global Quality Assurance, GMP Compliance

4 weeks ago

Atlanta, United States Daiichi Sankyo, Inc. Full time

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 16,000 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 is a global role that is responsible for quality compliance of drug substance, drug product and packaging manufacturing sites of DS products. These sites include both DS owned and contract manufacturing organizations (CMOs).

Provides QA leadership to support the preparation, execution, and remediation of regulatory inspections of the sites, implements and manages quality compliance programs, and leads mentoring and training activities. The incumbent leads a productive working relationship with internal/external stakeholders such as, but not limited to, contract manufacturing, testing, and/or warehousing organizations, DS affiliates and DS Headquarters in order to ensure the quality of drug products marketed globally and acts as a global partner to successful drive QA GMP organization deliverables as appropriate.

This position has a global responsibility to effectively drive the level of accountability and performance needed to achieve the full potential of the organization to deliver biological products to patients with unmet medical needs and to meet Daiichi Sankyo's vision to become a global pharma innovator with competitive advantage in Oncology.

Responsibilities

  • Inspection Readiness: Responsible for leading inspection readiness activities, including the execution of mock inspections, on-site inspection support during regulatory inspections, and assistance in any remediation and response activities resulting from regulatory inspections.
  • Executes comprehensive evaluations of GMP readiness status of the global supply chain of internal and external GMP manufacturing organizations, identifying and mitigating risks.
  • Ensures a satisfactory regulatory compliance level for DS internal and external organizations for local and global markets.
  • Liaises with regulatory agencies as needed and internally on GMP QA issues.
  • Leads Global GMP Compliance team’s participation in local, regional, and global project teams. Provides direction and consultation services for global project teams.
  • Responsible to contribute to the achievement of global QA vision and enhancing globalization at DS QA-GMP affiliates.
  • Proactively supports Global QA CMO Management and Global QA Audit Program teams.
  • Responsible to ensure that quality improvement initiatives at DS and Global External Suppliers are driven to completion through direction and collaboration with Global External Supplier QA teams.
  • Collaborate with Global Quality Management System (QMS) teams on regulatory-related CAPAs that impact remediation or other projects as assigned.
  • Collaborate frequently with Supply Chain, Pharmaceutical Technology, Regulatory colleagues and Global Quality Systems groups to recommend metrics and report the state of GMP Quality and compliance of Daiichi Sankyo and its GMP vendors.
  • Supports Supply Chain and Pharmaceutical Technology functions in the vendor selection process to assure that all newly selected vendors are operating in compliance with the applicable quality program and regulations/ guidelines and are prepared for Regulatory inspections.
  • Collaborate with Global RD/ PV QA teams for any cross-functional regulatory inspections impacting GMP activities and serve as a point person for GMP-relevant matters. Maintain up-to-date knowledge of current Good Manufacturing Practice (cGMP) regulations. Train and mentor staff on global GMP regulations and guidance.
  • Develop and motivate staff to develop a mature GMP and Quality Culture. Hold self-accountable to achieve the level of integrity, ethics necessary to drive sustainable results and performance, including development and maintenance of a culture driven by values of integrity, respect, and speak-up principles.
  • Create an environment that thrives on innovation, and proactive quality and is disciplined to efficiently execute against pre-defined deliverables. Drive employee engagement, mentoring, coaching and performance management. Communicate clearly and in a timely manner with supervisor, the Global QA organization and local leaders of DS QA-GMP affiliates to address and identify a proactive solution for business contribution, and the ability to effectively manage conflict with diplomacy.
  • Ensure effective influential skills to support the vision and strategy of the Global QA mission across boundaries and with different stakeholders. Continuously review compliance metrics trends from regulators/ industry experts and advise the GMP road map to meet changing regulatory and business needs.
  • Lead remediation 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, CMOs, and other key company partners to ensure a culture of compliance at all levels.
  • Create and maintain project management methodologies. Support the global GMP 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
Master's Degree preferred

Experience Qualifications

  • 5 or more years direct Health Authority experience desired
  • 10 or more years professional experience at a management level, leading a QA organization or regulatory authority and demonstrated track record of successful results required.
  • 7 or more years of professional experience managing many aspects of quality in an international, global context in a regulated healthcare environment required.
  • Must have experience working with biologics.
  • Proven expertise in risk management, continuous improvement, change management, and evolving the capabilities of an organization required.
  • Demonstrated experience working directly with global Health Authorities (FDA, EMA, MHRA, etc.) and other government and local agencies required.
  • Must have strong working knowledge of the end-to-end manufacturing process and laboratory operations required.
  • Must have solid understanding of quality management and continuous process improvement principles including global cGMP and GLP requirements required.
  • Physical Requirements standing and walking for long periods of time, ability to climb stairs, and perform gowning in laboratory and manufacturing sites.

Travel

Must have ability to travel up to 50% including overnight and international travel

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.