Manager QA Systems Management

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

Accountable for supporting and managing the Quality Management System (QMS) in accordance with regulatory requirements and ensuring adherence to the Quality Manual.

Responsible for ensuring efficiency, accuracy, and standardization in document management and data integrity. The incumbent is responsible for authoring, reviewing, and managing the development of internal procedures to ensure compliance with global and harmonized Quality Standards and regulatory requirements for the GMP area.

Additional responsibilities include:

Creating and reviewing Quality Assurance Agreements with contract organizations

Managing a Quality Assurance Agreement system to oversee vendor qualification programs

Evaluating critical operations data for Annual Product Reviews

Overseeing the stability studies program for drug products marketed in and exported from the US

Responsibilities

Quality Assurance Agreements

Manage a comprehensive system for establishing local and global Quality Assurance Agreements

Ensure all external contractors involved in manufacturing and testing meet GMP compliance

Support stable and quality supply in line with local and international regulations

Proactively plan and complete QA Agreement reviews in a timely manner

Change Control System

Oversee an effective Change Control System to capture and manage proposed changes

Ensure timely communication with internal and external partners

Strategically address changes to minimize impact on commercial and investigational product availability

CAPA Management

Ensure oversight of CAPA Management activities

Communicate promptly with internal and external stakeholders

Monitor and enforce CAPA completion deadlines per internal procedures

Product Data Management

Collect and evaluate critical manufacturing data

Author Annual Product Reviews

Track complaints, deviations, and change controls

Create trend evaluations to maintain high quality standards

Oversee the stability studies program in coordination with contract testing laboratories

Quality Metrics

Collect and analyze data on deviations, CAPA, Change Controls, OOS, and audits

Report Quality Metrics periodically to Senior Management

Identify potential quality issues and propose solutions

Development of Standards, Procedures (SOPs), and Training

Liaise with GMP areas to ensure procedural compliance

Implement global/regional QA GMP Standards and Procedures

Support SOP authoring and review processes

Provide training on QA System Management processes

Cross-Functional Team Participation

Collaborate with local and global functions for process alignment

Ensure regulatory compliance and best practices

Align cross-functional processes for global standardization

Qualifications

Successful candidates will be able to meet the qualifications below with or without reasonable accommodation.

Education Qualifications

Bachelor's Degree in a scientific discipline

Master's Degree or other advanced degree – Preferred

Experience Qualifications

Must have 4 or more years in professional pharmaceutical, biological operations experience, including drug manufacturing, packaging, QA, compliance, and auditing

Demonstrated knowledge working within various pharmaceutical dosage forms

Knowledge of multinational drug regulations

Proven understanding of quality management and continuous process improvement

Previous management experience would be a plus

Travel

Ability to travel up to 10%, including overnight 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.

Full-Time