Manager QA Systems Management
Daiichi Sankyo, Inc.
Bernards, NJ
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Responsibilities
- Quality Assurance Agreements: Manages 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. Ensure proactive planning and completion for QA Agreements establishment and review process in a timely manner as necessary.
- Change Control System: Manages an effective Change Control System able to capture and deal with changes proposed by manufacturers, customers, internal improvements and/or Health Authorities requirements. Responsible for communicating in timely manner with several internal and external partners and functions to properly address all the proposed changes, ensuring the right QA assessment and looking for the best strategy to avoid any impact on commercial and investigational products availability to cover patient needs.
- CAPA Management: Ensure oversight into CAPA Management activities to define and follow the completion plan up. Responsible for communicating in timely manner with several internal and external partners and functions to ensure the deadline of CAPA plan is followed on rigor as per defined in the internal procedures.
- 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 to the product and creating a trend evaluation scenario to ensure that products are following high quality standards to meet patient needs.
Qualifications
Education Qualifications
A Bachelor's Degree in scientific discipline is required.
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 is preferred
Must have proven expertise with various pharmaceutical dosage forms
Demonstrated experience dealing with multinational drug regulators.
Must have strong understanding of quality management and continuous process improvement principles including global cGMP requirements.
Travel Requirements
Ability to travel up to 10% of the time, 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.
Salary Range:
USD$124,960.00 - USD$187,440.00