Specialist, QA System 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 for support Quality Management System (QMS) operation in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible to ensure efficiency, accuracy and standardization in high commitment level for document management and data integrity.

The incumbent is responsible for authoring, review and execute the development of internal procedures to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation, review and control of Quality Assurance Agreements with contract organization. Collect, conduct and evaluate data for critical operations related with Annual Product Reviews. Support the completion of stability studies program of drug products marketed in US and exported from US. Ensure the storage and retention of the documents in accordance with internal procedures establishing elemental tools that can provide accurately and safety access.


Quality Assurance Agreements: Ensure planning and completion for QA Agreements establishment and review process activities in a timely manner as necessary. Working close to ensure the robustness of a comprehensive system for the establishment of local and global Quality Assurance Agreements in order to assure that all external contractors involved in manufacturing and testing of drug products for commercial and investigational purposes, drug substances, intermediates and service providers provide GMP compliant activities ensuring the stable and quality supply as per local and international regulations and guidelines satisfying DS requirements and supporting the company’s vision.

Change Control System: Responsible to review, evaluate and communicate in timely-manner with several internal and external partners and functions in order to properly address all the proposed changes, ensuring the right QA assessment and looking for the best strategy to avoid any impact for the quality, safety and efficacy of commercial and investigational products and its availability. Supports the management of an effective Change Control System able to capture and deal with changes proposed by manufacturers, customers, internal improvements and/or Health Authorities requirements.

CAPA Management: Ensure and rely on activities for CAPA Management in order to follow the completion plan up. Responsible to communicate in timely-manner with several internal and external partners and functions in order to ensure the deadline of CAPA plan is followed on rigor as per defined in the internal procedures. Responsible to address the fails in properly track CAPA Management system to the Senior Management in timely manner.

Product Data Management: Responsible to collect and/or evaluate data information from critical manufacturing steps process and authoring Annual Product Review as per internal procedures and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario to ensure that products are following high quality standards to meet patient needs. Responsible to support the performance of activities related with stability studies program in accordance with internal procedures and regulatory requirements in connection with contract testing laboratories to ensure the compliance for products marketed and/or distributed locally. Authoring or reviewing stability studies protocol or reports. Support the activities related with the updating of technical registration document among another GxP functions.

Quality Metrics: Collecting and analyzing data related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance and reporting Quality Metrics in a periodical manner and communicate this to Senior Management organizing Quality Meeting sessions, identifying potential quality issues and proposing suitable solutions fostering a preventive mindset across the team and to the organization based on the metrics collected.

Development of Standards and Procedures (SOPs) and Training: Liaise with GMP areas to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. Responsible to author, adhere and implement key global/regional QA GMP Standards, Procedures and Instructions. Supporting SOP authoring and reviewing process among GMP functions. Responsible to provide enough training for the related GMP and non-GMP activities involved with QA System Management processes.

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. Master’s degree level 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.
  • Direct experience dealing with multinational drug regulators. 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.