Associate Director, Quality Assurance, Gcp, CSV

Job Description

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 position provides leadership and oversight for implementation of DSI's GxP computer system validation (CSV) lifecycle and related QA-CSV strategies, providing oversight and guidance for compliance with Daiichi Sankyo expectations, business and regulatory requirements and industry best practices. This position interacts within Quality Assurance sub-functional and cross-functional teams, vendors and consultants, and leads the supporting QA-CSV outside service resources.

This position participates in global GxP-CSV projects and contributes to or participates in global computer system validation working groups. Additionally, this position leads or participates in the QA-CSV vendor audit program.

• This position solves problems and makes decisions according to established guidelines, regulations, DS procedures and experience, and makes some strategic decisions; escalates issues to management as necessary. As required by business needs, this position performs specific tasks across other QA-CSV levels.

Responsibilities

• Computer System Validation Work Coordination Activities And Regulatory Guidance: Provides leadership and oversight by scheduling, prioritizing and coordinating QA-CSV projects, activities and resources, to assure adequate coverage and support to meet business needs.
  
  Supports direct report's work by selecting and appointing QA consultant resources, when necessary, including review of work proposals to assure they are appropriate and reasonable and within project budget. Confers with cross-functional team members as necessary to acquire QA-CSV project resource budget. Provides regulatory guidance and expertise on the validation approach to project teams as necessary. Participates in global GxP-CSV projects as QA-CSV resource.

• Computer System Validation Documentation Review: Provides leadership and oversight by scheduling, prioritizing and coordinating QA-CSV projects and review activities to assure adequate coverage and support to meet business needs and assure inspection readiness.
  
  Selects and manages supporting QA-CSV consultant resources. Conducts high level review of selected documentation and may be the primary QA-CSV resource for specific CSV projects. Addresses escalated issues from direct report(s) and coordinates review while providing expertise on the validation approach.

• Computer System Validation Policies and Procedures: Authors, evaluates, and implements CSV procedures, assuring alignment with local and global policies and procedures and regulatory requirements and industry best practices. Authors or participates in the development of local and global validation policy and standards.

• Vendor Audit Program: Provides leadership and oversight by scheduling and prioritizing activities for the Daiichi Sankyo QA-CSV vendor audit program, or supports these activities. Either leads or participates in the QA-CSV vendor audit program, partnering with Outsourcing, GMP/GCP QA and cross-functional personnel; coordinates internal or external audit resources and audit activities to meet scheduling and business needs.

• Process Improvements: Identifies potential process improvements per project and potentially across other projects, evaluating industry best practices and regulatory guidance and requirements. Assesses and implements process improvements.

• Regulatory Guidance and Oversight: Provides direct or indirect support for regulatory inspections and internal/external audits of DSI related to validated computerized systems and related procedures.

• Management and Career Development for Personnel: Provides leadership, feedback and coaching to direct reports for personal development of team members.

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 in the Life Sciences or a related field required

Experience Qualifications

• 7+ years of related pharmaceutical experience, including firsthand knowledge of GxP computerized system validation and system development life cycle processes required

• Experience auditing GxP computerized system validation documentation processes required

• Experience with CSV auditing software vendors and clinical study service providers (e.g. CROs) required

• Where line management is required, experience providing direct supervision preferred

Travel

Ability to travel up to 30% On-site support/meetings at various Daiichi Sankyo and vendor locations as necessary.

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.

Apply Not ready to Apply?