Manager, Validation Lead

2 weeks ago

Bernards NJ 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

Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and company policies and procedures. Provide expertise and solutions to CSV questions and issues.

Responsibilities

- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global DX, and QA-CSV/eCompliance team members to ensure compliant, efficient and timely completion of global DX GxP and Non-GxP CSV projects. Define validation activities, timelines and resource requirements for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business expectations to execute regulatory-compliant computer system validation or qualification of global GxP and Non-GxP computer systems.Create and review various validation documentation such as Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective communication with project stakeholders.
- Provide oversight to assure that all validation work performed for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit documentation.
- Author, update and maintain Global DX Computer System Validation policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance indicators and participates in SDLC Lessons Learned sessions to evaluate validation process improvements and efficiencies and measure key success factors.
- Drive continuous improvement and maintain current knowledge of cGMP regulatory issues, Good Automated Manufacturing Practices (GAMP5) and Good Practices Guides, Risk-Based Approach/Computer Software Assurance (RBA/CSA) to assure related Daiichi Sankyo business needs are met. Maintain the Global DX global validation methodology in accordance with current regulatory guidelines.
- Provide appropriate training and guidance on global DX computer system validation procedures and policies to Daiichi Sankyo employees and contractors/consultants involved with GxP and Non-GxP computerized system validation and/or usage to assure an understanding of, and compliance with, Daiichi Sankyo requirements.

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 Minimum of a Bachelor's degree in physical, life or computer sciences required

Experience Qualifications

- 4 or More Years Five or more years’ experience with a world-class quality organization.
- 4 or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related to pharmaceutical operations. required
- 1 or More Years Direct dealings with FDA, EMA, PMRA, other regulatory agencies. preferred
- 1 or More Years Strong appreciation of the impact of regulatory bodies on pharmaceutical operations. preferred
- Experience auditing software vendors is preferred. preferred
- International experience preferred; at minimum, experience working with diverse cultures and employees is required.

Travel

Ability to travel up to 10% Travel to Europe, Japan and other DS locations.

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.

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