Manager, Product Release Management

, NJ, United States

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 120 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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

Job Summary:

Accountable to manage and oversee QA GMP activities pertinent to commercial and Investigational Medicinal Products (IMP) to ensure the timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and compliance with regulatory guidelines and internal/global standards and procedures. Responsible for managing activities within the Commercial and IMP Release Program which include management of product release programs, deviation investigation programs, standards development and training activities, and supporting complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract Manufacturing Organization (CMO) leading a productive working relationship with internal/external stakeholders acting as partner to successfully drive commercial and IMP deliverables as appropriate.

Responsibilities

Drug Product Release: Manages the execution of assigned responsibilities within the commercial drug product and IMP release program to assure 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. Support proactive planning and forecasting for commercial and IMP relevant activities and QA batch review and release process as necessary.

Complaint and Recall Programs Establishment: Manages and participates in the commercial and IMP 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 and IMP drug products to ensure a timely investigation and that protective solutions identified to avoid significant quality or patient. Execute all recall operations activities and process directed by management when necessary.

Deviation Investigation Program: Manages and participates in the deviation investigations for commercial and IMP as a result of distribution practices, manufacturing sites, clinical sites and testing laboratories and assures they are documented and resolved to ensure the quality standards required for DS products are met. Collaborates with internal and external stakeholders to complete deviations in a timely manner.

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

Cross-Functional Team Participation: Participates and supports development of cross-functional teams to provide product quality/GMP support for timely activities related with the release, planning and supply forecast of commercial and IMP drug product. Supports regulatory inspection and its readiness. Works diligently with CMO representatives and analytical labs in order to ensure the compliance for activities performed. Provides accurate and timely information for leadership to support the decision-making process.

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 scientific discipline preferred or

Master's Degree or other advanced degree preferred

Experience Qualifications

4 or More Years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit or equivalent experience preferred

4 or More Years Experience with various pharmaceutical dosage forms preferred

4 or More Years Solid understanding of quality management and continuous process improvement principles preferred

Travel

Ability to travel up to 5% Travel (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.

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