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

Date Posted: 4/3/2020

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 lead, oversee and manage team responsible GMP activities pertinent to investigational products as per applicable regulatory standards and company expectations supplied in US territory for local and international clinical trials and the release of investigational drug product in accordance with FDA premises and regulation.

The incumbent is responsible for the establishment of an Investigational Drug Product Release Program which includes Product Complaint and Program Recall process and direction on product release programs. This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract Manufacturing Organization leading a productive working relationship with internal/external stakeholders acting as partner to successful drive IMP deliverables as appropriate.


Drug Product Release: Exercise leadership in order to establish, implement and execute a comprehensive investigational drug product release program and assures that all external contractors provide GMP compliant release documentation. Ensure proactive planning and forecasting for IMP relevant activities and QA review process as necessary. Ensure QA teams are fit for purpose to deliver against projected milestones and on time batch review and release process are in place and as per pre-defined procedure.

Complaint and Recall Programs Establishment: Provides leadership for the drug product complaint investigation program. Administers and coordinates with the Clinical Supply Operation function for the receipt, logging, and assignment of complaint investigations for investigational drug products at all applicable investigational 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 investigational drug products. Provides and involves recall operations and process directed by management when necessary.

Deviation Investigation Program: Provides leadership and direction for investigational drug product deviations investigations occurred at manufacturing sites and testing laboratories, and assures they are documented, resolved, and appropriately trended to ensure the Quality standards required for DS products.

Development of Standards and Procedures (SOPs) and Training Activities: Accountable for and directs the development of procedural documents that set compliance in QA GMP processes and systems for contribution of Quality Management System (QMS) establishment. Responsible to ensure the completeness and accurate timeline review and training for the relevant functions at DSI organization.

Cross-Functional Team Participation: Supports as a cross-functional team member to provide product quality/GMP support for the development of a new investigational entity and the clinical trial requests to successfully accomplish with the existing timeline. Leadership DSI QA participation in Clinical Research and Development teams, including managing the assignment of Quality Assurance members to various development teams and providing direction and consultation and, also, supporting global initiatives and activities.

Management and Career Development for Personnel: Employ, maintain, develop and motivate staff to develop leaders throughout a continues leadership, feedback and coaching. Ensure long- and short-term career planning of direct reports and entire function. Hold own self and staff accountable to achieve the level of integrity, ethics necessary to drive sustainable results and performance.

Budget Management: Prepare and adhere to annual budget to manage expense expectations and provide fiduciary oversight to the QA function.

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

  • Bachelor’s Degree in scientific discipline is required. Advance degrees preferred.
  • Minimum 7 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.
  • Experience leading world-class quality organization.
  • Direct experience dealing with multinational drug regulators and direct reports. Previous management experience.
  • Solid understanding of quality management and continuous process improvement principles including global cGMP requirements.
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.