Senior Manager, Vaccines Process Development and Analytics QA at Takeda

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Job Description

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 building strategic Quality programs to ensure that all non-clinical (GLP and development) studies, conducted globally, either internally and outsourced, comply with relevant regulations. Also the 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.
• Develops phase appropriate procedures to deliver harmonized quality oversight across multiple development labs.
• Partner with team members and team members to promote quality, compliance, and data integrity principles across process development and analytical activities, and programs.
• Is responsible for the oversight and review of regulatory submission content generated by the development labs

How you will contribute:

• Leads 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 in 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. Implement endorsed solutions.
• Is a technical SME that maintains current understanding of regulations and 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 developing 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.
• Can create and development strategies to ensure phase appropriate oversight of labs
• Demonstrated experience in providing guidance to partners and peers.
• Independently manage projects, carries out root-cause investigations, analyzes data and makes recommendations to management
• Monitor and achieve established goals and projects.
• Analytical capabilities to determine potential risks.
• And 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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and 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, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in 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