What are the responsibilities and job description for the Regulatory Implementation Services Lead position at Daiichi Sankyo US?
Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.
Summary
The Regulated Implementation Services Lead plays a key role in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.
The Lead is responsible for defining and driving the methodology, approach, and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional Global DX teams to ensure seamless, compliant service delivery and oversees resource planning for GDX global and regional projects requiring Validation services and Technical Lead assignments.
Responsibilities
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education (from an accredited college or university)
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 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.
Summary
The Regulated Implementation Services Lead plays a key role in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.
The Lead is responsible for defining and driving the methodology, approach, and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional Global DX teams to ensure seamless, compliant service delivery and oversees resource planning for GDX global and regional projects requiring Validation services and Technical Lead assignments.
Responsibilities
- Oversee and manage a team of Validation Leads and Technical Leads to ensure validation and technical implementation align with business priorities, GxP regulations (e.g., Part 11), laws (e.g., GDPR), and DS standards (e.g., SDLC, CSV).
- Drive continuous improvement by applying expertise in GAMP5, Good Practices Guides, and RBA/CSA methodologies to ensure compliance and inspection readiness.
- Stay current with emerging technologies and industry trends; lead feasibility studies, prototype development, and advocate for scalable, compliant architecture and design.
- Collaborate with global quality, IT, and business leaders to align deliverables with strategic goals and regulatory requirements; drive improvements via KPIs, SDLC lessons learned, and best practices.
- Serve as the escalation point for critical issues; act as a liaison between technical teams, validation teams, and stakeholders to ensure alignment on priorities and requirements.
- Oversee resource planning for global and regional DX projects, strategically assigning Validation services and Technical Leads based on needs, capacity, and skillsets.
- Demonstrate deep expertise in GxP regulations and validation standards (e.g., 21 CFR Part 11, Annex 11); possess a strong understanding of IT system architecture and cloud-based environments.
- Manage third-party vendors, system providers, and validation partners to ensure compliance, contract fulfillment, and service excellence.
- Oversee global project budgets to ensure cost-effective solutions that meet compliance and technical standards; drive vendor assessments, audits, and performance evaluations.
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education (from an accredited college or university)
- Bachelor's Degree in Computer Science, Life Science, Engineering, Information Technology, or related field – Required
- Master's Degree in Computer Science, Life Science, Engineering, or Information Systems – Preferred
- 10 years of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/medical device industry – Required
- 4 years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level – Required
- 7 years of strong expertise in GxP regulations, CSV, 21 CFR Part 11, Annex 11, GAMP 5, and data integrity – Required
- Deep understanding of IT system architecture, cloud solutions, integrations, and cybersecurity in regulated environments – Preferred
- Strong strategic thinking, decision-making, and leadership skills – Preferred
- In-depth knowledge of GxP application solutions and regulatory compliance
- Proven ability to manage and deliver complex projects using SDLC in regulated environments
- Experience in digital transformation, process improvement, and operational excellence
- Skilled at leading global, cross-functional teams with strong relationship-building skills
- Excellent communication, listening, and stakeholder engagement skills
- Strong analytical, organizational, and time management capabilities
- Proficient in Microsoft Office Suite (Word, Excel, Access, Visio, PowerPoint, Project); familiarity with pharma business applications
- Customer-centric mindset with the ability to multitask in a dynamic, fast-paced environment
- Ability to travel up to 10%
- Travel includes visits to DSE, DSJ locations, including international travel to the US, EU, and Japan
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.
