Senior Quality Assurance Specialist

1 month ago

San Francisco, California, United States Daiichi Sankyo, Inc. Full time

Unlock Your Potential in a Legacy of Innovation

Daiichi Sankyo Group is a pioneer in pharmaceutical therapies, dedicated to improving standards of care and addressing unmet medical needs globally. With a rich legacy of innovation and a robust pipeline of promising new medicines, we're committed to delivering exceptional quality and excellence in all we do. As a Senior Quality Assurance Specialist, you'll play a critical role in driving our Global R&D PV QA strategy, collaborating with cross-functional teams to ensure seamless execution of projects and initiatives. Your expertise will be instrumental in shaping our QA vision and implementing culture change initiatives that drive business growth and excellence.

Key Responsibilities:

  • Drive the implementation of Global R&D PV QA strategy, collaborating with Associate Director Global Strategy and Operations and Head Global Strategy and Operations.
  • Support the development of onboarding materials and ensure proper onboarding and training processes are in place for RD PV QA.
  • Collaborate with Global QA functions to solve contract-related problems and ensure compliance with all contract requirements.
  • Provide Strategy Operations support for regulatory inspection-related activities, ensuring logistics for inspections and collection, storage, and maintenance of inspection documentation.
  • Work closely with QA leadership to develop recommendations for process improvement projects and initiatives.

Qualifications:

Education Qualifications:

  • A High School Diploma is required.
  • Associate's Degree strongly preferred.

Experience Qualifications:

  • 4+ years of professional experience within the pharmaceutical industry working within Quality Assurance is required.
  • Must have a broad understanding of Health Authority expectations in the areas of Pharmaceutical Development, working in a GxP regulated environment, pharmaceutical industry.
  • Proven experience in training and curricula development, including oversight and administration of validated electronic systems.
  • Strong interpersonal, communication, technical writing, negotiation, and problem-solving skills with demonstrated ability to build collaborative relationships.
  • Strong project management skills.
  • Organizational awareness, including experience working cross-functionally and in global teams.
  • Candidate must be creative, show initiatives, be customer-focused, results-driven, and be able to work effectively in a global environment.
  • In-depth knowledge and working experience with common computer software programs, i.e., MS Office Suite.

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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