SR. Director, Head of Document Mangement & Training GQA

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 100 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. 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 role is key leadership position within Global QMS and Global Quality Assurance. Overall accountability is develop strategic framework work for GxP document management and GxP training across DS group including business units, functional units and corporate functions.
• Lead Training function team and Document and record management function team to enhance training and document and record management across Global cross functional GxP areas in the DS group
• Responsible for the development of cross-functional training strategies Strategic roadmap including , infrastructure, programs, and document/record management principles
• Responsible for the development of document and record management principles for Global GxP activities

Responsibilities

Training Function

• Team Lead development of strategies for the needs assessment, design, planning, delivery, and evaluation of training across the organization. Work with functional GQA ( GMP RDPV) on implementation of strategy including development of role based curriculum approach and resources for training administration.
• Lead establishment and enhancement of common Global infrastructure for training, including systems, tools, materials, facilities, and trainers
• Working with eCompliance as Global Business owner for ALTOS global system following governance model
• Lead training related risk analyses and escalate them to senior leadership in GQA
• Responsible for development, oversight, and maintenance of GQA training programs to ensure cross-functional transparency and consistency
• Ensure necessary support is provided to QA functions to develop training curriculums and conduct them in line with the overarching training strategies

Document and record management function

• Lead document hierarchy definition, and ensure GxP documents across the organization follow the hierarchy
• Lead establishment of principles for document and record management processes including authoring, review, approval, storage, and revision
• Responsible for development, implementation, oversight and maintenance of document and record management principles
• Ensure tools and materials related to Global QMS documents are properly overseen and managed. Working with eCompliance as Global Business owner for Veeva Vault/QDocs global system following governance model
• Ensure administrative support is provided to QA functions including assigning document IDs and quality check to ensure documents and records are properly managed
• Ensure support is provided to QA functions to manage GxP documents and records in a way aligned with the overarching document and record management principles

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)

• Must have a Bachelor's Degree Bachelor's degree (Scientific discipline). A master's degree or advanced degree is preferred.

Experience Qualifications

• Must have 10 or more years of progressive experience in GxP related functions including at least 5 plus years of experience within progressive GxP-Quality Assurance or equivalent
• Must have a minimum of 5 years of expertise within Global Document and Record Management and Training functions
• Must have proven people leadership experience.
• Must have demonstrated project management skills and experience working on global projects and teams
• Must have proven ability to work cross-functionally within a matrixed global teams environment
• Must have a broad understanding of quality management system, GxP regulations and industry trend/practice
• Must have strong interpersonal skills to build collaborative relationships
• Must have excellent written and oral communication skills. Strong command of English

Preferred Skills

• Extensive knowledge and experience in developing and managing training programs and infrastructure
• Experience with Veeva Quality Docs System & ComplianceWire training platforms

Travel Ability

• Must have the ability to travel up to 10% both domestic and internationally.

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.