This role can be done remote from the United States.
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 is a global role that is accountable to lead, oversee and manage teams responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance, drug product and packaging manufacturing sites of DS products. These sites include both DS owned and contract manufacturing organizations (CMOs). Ensure adequate QA leadership to support the preparation, execution and remediation of regulatory inspections of the aforementioned sites. The incumbent leads a productive working relationship with internal/external stakeholders such as but not limited to contract manufacturing / testing and/or warehousing organizations, customer, DS affiliates and DS HQ's in order to ensure the quality of drug products marketed globally and acts as a global partner to successful drive QA GMP deliverables as appropriate. This position has a global strategic and influential responsibility to effectively drive the level of accountable and performance needed to achieve the full potential of the organization to deliver pharmaceutical and medical device products to patients with unmet medical needs.
This role requires a candidate with either current or past work experience as a Biologics Inspector directly within any of these agencies: FDA, EMA or MHRA
- Inspection Readiness: Responsible for the development of strategic guidance on Inspection Readiness and 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 in order to ensure timely approval of new drug applications and/or the approval of LCM changes to our ADC products.
Exhibit leadership to execute a comprehensive evaluation process of the GMP readiness status of our global supply chain of internal and external GMP manufacturing organizations.
Ensures the compliance level for these organizations to maintain regulatory compliance with local and global markets. Liaises with regulatory agencies and internally on GMP QA issues.
- Stakeholder management (Internal and External)
Leads and directs the Global GMP Compliance team’s participation in local, regional, and global project teams. In collaboration with regional team leaders, will manage the assignment of GMP QA members to various working groups and provide direction and consultation
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.
- Quality Initiatives:
Responsible to ensure that quality improvement initiatives at 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 colleagues and Global Quality Systems to establish metrics and report the state of GMP Quality and compliance ofDaiichi Sankyo, its GMP vendors to senior management at management review and more expeditiously where required
Works with 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 and FDA, EMA, ICH guidelines, and inspection trends applicable to company operations. Train and mentor staff on global GMP regulations and guidance.
- Leadership and Team management
Employ, maintain, develop and motivate staff to develop leaders throughout a continues leadership, feedback and coaching. Ensure long- and short-term career planning of direct reports and entire function. Hold own self and staff accountable to achieve the level of integrity, ethics necessary to drive sustainable results and performance.
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, and inclusivity and one that adheres to the principles set forth in the organization (JOIN, GROW, THRIVE)
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 May serve as deputy of VP, Quality GMP in leadership meetings to communicate and deliver the current state of GMP compliance of the DS supply chain as needed.
Communicate clearly and in a timely manner with 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. This includes effective and empowered management supports to direct reports.
- 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 GMP 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, CMOs, and other key company partners to ensure a culture of compliance at all levels
Create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization.
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
- Candidate must have either current or recently past work experience/employment as a biologics inspector directly within either the FDA, EMA or MHRA
- 10 or More Years 12+ years of previous experience at a senior management level leading a QA organization or regulatory authority and demonstrated track record of successful results required
- -Significant experience in managing many aspects of quality in an international, global context in a regulated healthcare environment required
- Experience in Pharma, Medical Device, Vaccines, Diagnostics, Generics, Consumer Products preferred
- Experience in sterile operations, antibody manufacturing required
- Strong expertise in continuous improvement, change management and evolving the capabilities of an organization required
- Experience working directly with global Health Authorities (FDA,EMA, MHRA) and other government and local agencies required
- Working knowledge of the end-to-end manufacturing process required
- Solid understanding of quality management and continuous process improvement principles including global cGMP requirements
Ability to travel up to 20% 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.