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Manager, Product Release Management
2 months ago
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
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 orMaster's Degree or other advanced degree preferredExperience 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 preferred4 or More Years Experience with various pharmaceutical dosage forms preferred4 or More Years Solid understanding of quality management and continuous process improvement principles preferredTravel
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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