Senior Manager, Vaccines Process Development and Analytics QA

2 weeks ago


Boston, Massachusetts, United States Takeda Full time
About the Role

The Senior Manager, Vaccines Process Development and Analytics QA will be responsible for ensuring the quality and compliance of vaccines process development and analytics labs. This includes creating and implementing strategic quality programs, developing phase-appropriate guidance, and leading quality oversight for GLP and non-GxP submission-related content.

Key Responsibilities
  • Lead qualification and compliance assessments of external service providers conducting non-clinical studies and other related process development activities.
  • Guide quality programs across multiple internal and external groups to maintain quality, compliance, and consistency across projects in development.
  • Develop and implement phase-appropriate quality oversight across multiple development labs, including developing strategies, authoring procedures, and technical guidance documents.
  • Review internal/external non-clinical studies to assure data integrity and suitability of reports and associated raw data for regulatory submissions.
  • Collaborate with partners to resolve findings and provide leadership and subject matter expertise to ensure well-documented and compliant studies.
  • Drive collaboration with quality team members and company partners to support projects and goals.
  • Lead regulatory submission needs by fulfilling requests for compliance-related documentation about suppliers.
  • Independently identify quality and compliance gaps, communicate to management, and implement endorsed solutions.
Requirements
  • Bachelor's degree in Chemistry, Biology, Engineering, or related field.
  • 6+ years of experience in Quality and Compliance, with experience working in GLP biopharmaceutical research.
  • Master's degree in Chemistry, Biology, Engineering, or related field.
  • Comprehensive knowledge of domestic and international GxP regulations, related regulations, and guidance documents.
  • Demonstrated QA auditing skills and quality-related risks and potential impact.
  • In-depth knowledge of nonclinical operations, ability to interpret requirements, anticipate issues, make informed decisions, and respond to latest quality situations.
About Takeda

Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws.



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