Job Title : Senior Manager, Vaccines Process Development and Analytics QA
Location : Cambridge, MA
About the role:
The Senior Manager, Vaccines Process Development and Analytics QA will report to the Team Lead Global Systems Vaccine Quality and is accountable for the quality oversight of the vaccines process development labs and analytics (VRA) labs, and MS&T labs. You will create and build strategic Quality programs to ensure that all non-clinical (GLP and development) studies, conducted globally, either internally or outsourced, comply with relevant regulations. This role will develop and implement phase-appropriate guidance in collaboration with global SMEs to ensure harmonized oversight within VBU. You will spearhead quality oversight for GLP and non-GxP submission-related content. Independently execute quality assurance measures to lead compliance of in-house or outsourced non-clinical process development and analytics studies (e.g., GLP, non-GxP submission-related) with applicable regulations and Takeda standards. Lead the vaccines quality interface for supplier qualification activities for externalized non-clinical studies. Develop phase-appropriate procedures to deliver harmonized quality oversight across multiple development labs. Partner with team members to promote quality, compliance, and data integrity principles across process development and analytical activities, and programs. Responsible for the oversight and review of regulatory submission content generated by the development labs.
How you will contribute:
- Lead qualification and compliance assessments (either by direct audit participation or by management of contract auditors) of external service providers conducting non-clinical studies and other related process development activities.
- Guide quality programs across multiple internal and external groups (partners and third parties) 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, and harmonizing approach with SMEs in global Takeda.
- Develop clear roles and responsibilities between VBU and R&D for any shared services.
- Review internal/external non-clinical studies to assure data integrity and suitability of reports and associated raw data to regulatory submissions. Collaborate with partners to resolve findings.
- 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 (e.g., U.S. FDA Establishment Inspection Reports, Health Canada GLP Certificates).
- Independently identify quality and compliance gaps, communicate to management, and implement endorsed solutions.
- Act as a technical SME that maintains current understanding of regulations and guidance documents and assess compliance.
- Develop and implement measurements and quality metrics to lead process improvements within development.
- Establish and maintain relationships with Research QA team members to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs.
- Identify quality risks to non-clinical projects and develop mitigation strategies in partnership with the business.
What you bring to Takeda:
- Bachelor's degree in Chemistry, Biology, Engineering, or related field.
- 6+ years of experience in Quality and Compliance.
- Experience working in GLP biopharmaceutical research.
- Master's degree in Chemistry, Biology, Engineering, or related field.
Abilities/Experience:
- 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.
- Ability to create and develop strategies to ensure phase-appropriate oversight of labs.
- Demonstrated experience in providing guidance to partners and peers.
- Independently manage projects, conduct root-cause investigations, analyze data, and make recommendations to management.
- Monitor and achieve established goals and projects.
- Analytical capabilities to determine potential risks related to quality expectations and regulatory compliance, produce action plans, and implement solutions.
Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- Be required to wear personal protective equipment (PPE) and other clean room garments daily, including safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets, gloves, and hearing protection.
- Need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
EEO Statement
Takeda is proud of its commitment 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, and any other characteristic protected by law.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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