Manager QA Systems Management

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.

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

• 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

• 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

• Ensure oversight of CAPA Management activities

• Communicate promptly with internal and external stakeholders

• Monitor and enforce CAPA completion deadlines per internal procedures

• 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

• 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

• 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

• Collaborate with local and global functions for process alignment

• Ensure regulatory compliance and best practices

• Align cross-functional processes for global standardization

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

• 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

• 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.