Specialist, QA Product Release Management in Basking Ridge, NJ at DSI

Date Posted: 5/11/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

Accountable to review and comply with a comprehensive drug product release program for investigational medicine products and all the related activities to ensure the delivery of pharmaceutical products to patients with unmet medical needs on timely manner.

The incumbent is responsible to adhere and support Quality Management System and GMP Compliance Programs to assure product integrity and compliance with regulatory guidelines and internal/global standards and procedures.

Responsibilities:

Drug Product Release: Execute a comprehensive investigational medicine product release program and assures all external contractors provide GMP compliant product release documentation. Participates as a cross-functional team member to provide product quality/GMP support and assures proper documentation of drug product release programs in accordance with internal procedures. Ensure proactive planning and forecasting for IMP relevant activities and QA batch review and release process as necessary.

Complaint and Recall Programs Establishment: Participates in the drug complaint investigation program and recall handling program and assures proper documentation of complaints and timely investigation and operation. Supports the receipt, logging, and assignment of complaint investigations for commercial drug products at all applicable commercial contract manufacturer organizations and internally in order to ensure a timely manner activity and a protective solution to avoid any risk to the safety of commercial drug products. Comply with all recall operations activities and process directed by management when necessary.

Deviation Investigation Program: Participates in the investigation of production and analytical deviations associated with investigational medicine products occurred at manufacturing sites and testing laboratories and assures proper documentation of complaints and timely investigation and operation.

Development and Review of Standards and Procedures (SOPs) and Training Activities: Responsible for development and review of procedural documents that set compliance in IMP QA GMP processes and systems. Responsible to ensure the completeness and accurate timeline review and training for the relevant documents at IMP QA GMP Organization.

Cross-Functional Team Participation: Participates as a cross-functional team member to provide product quality/GMP support for timely activities related with the release of investigational medicine product. Works diligently to assure the observance to the safety of the patients during investigation process and provides accurately and fast information for leadership and to support the decision-making process.

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

Education/Experience:
  • Bachelor’s Degree in scientific discipline is required. Advance degree preferred.
  • Minimum 3 years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit. Experience with various pharmaceutical dosage forms is desired.
  • Solid understanding of quality management and continuous process improvement principles.
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.