Manager, QA Project Lead in Basking Ridge, NJ at DSI

Date Posted: 3/3/2020

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 manage and assists launching activities for new commercial drug products and to support improving activities in established products or processes internally or at contract manufacturing, testing or warehousing sites. Responsible for assisting operations which requires process validation, equipment qualification or analytical transference for commercial drug products manufactured, tested and/or warehoused on behalf of DSI.
This position interacts with cross-functional teams inside and outside the organization, as well as Contract Manufacturing Organizations leading a productive working relationship with internal/external stakeholders acting as partner to successful drive CDP deliverables as appropriate.

Responsibilities:

Packaging and Labeling Project Management: Manages and support transference packaging activities related with primary and/or secondary packaging and labeling for established or new commercial drug products at contracted packaging organizations. Ensure proactive planning and management for relevant activities involved in project management in order to comply with projected milestones. Responsible for artwork reviewing process for packaging compounds and to ensure that all applicable changes can be reflected on packaging material.

Analytical and Quality Control Project Management: Manages and support analytical transference activities and analytical validation projects to ensure that required analytical tests performed by contract analytical organizations are suitable transfer or validated as per regulatory guidelines and internal/global procedures or standards. Responsible to oversee stability studies program completion on behalf of DSI at outsourcing labs in order to ensure completeness and timely execution and that all out of specification/results are properly registered and investigated as per internal procedures.

Project Management: Responsible to develop and lead task activities related with QA GMP Projects for commercial drug product conducting assessment of manufacturing, packaging, analytical, warehousing and shipping operations to provide focused quality improvement opportunities. Collaborates to develop plans, studies and projects for continuous improvement strategies to drive operational excellence under QA standards.

Validation and Qualification Program: Provides management and direction for process manufacturing and cleaning validation activities at external contract manufacturing organizations to assure efficient and timely completion. Provides support to equipment qualification programs at external organizations which needs to comply with regulatory and internal requirements.

Cross-Functional Team Participation: Supports as a cross-functional team member to provide product quality/GMP support for new product launch initiatives and technology transfer of existing products to new contract facilities. Provides leadership for regulatory inspection activities including its readiness. Provides commercial QA support for key decisions that impact local operations and the budget. Works diligently with CMO’s representative and analytical labs in order to ensure the compliance for all activities performed. Collaborate with DS affiliate and global partners on Validation projects and tasks and manages QA-PV consultant resources to set and support validation activities when necessary.

Development of Standards and Procedures (SOPs) and Training Activities: Accountable for and directs the development of procedural documents that set compliance in QA GMP validation 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. Participate in developing of global validation policies, plans and standards and to reflect the best industry and regulatory practices on these documents.

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 degrees preferred

Minimum 5 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.

Validation experience in process, equipment, and laboratory qualification supporting manufacturing activities within the pharmaceutical industry.

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.