Quality Manager, Analytical Quality

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Job Description

About the Role

We are looking for a Quality Manager, Analytical Quality to provide technical quality oversight for commercial vaccine manufacturing and quality control activities across internal and external sites. In this role, you will take quality decisions, lead analytical method lifecycle management, and contribute to the commercialization and lifecycle management of global vaccine products. You will act as a subject matter expert in analytical methods, collaborate closely with cross-functional teams, and ensure compliance with cGMP, regulatory, and corporate standards.

How you contribute

• Lead cross-functional meetings with internal and external laboratories and subject matter experts.

• Drive analytical method lifecycle management (LCM) and oversee multi-site assay transfers.

• Act as SME for analytical methods, including biological, molecular biological, and microbiological methods used in commercial release testing.

• Troubleshoot and investigate laboratory and manufacturing issues in collaboration with technical experts.

• Apply statistical analysis for data interpretation to resolve complex analytical issues.

• Review and approve validation protocols, reports, SOPs, and regulatory documents.

• Ensure compliance of methods with GMP, pharmacopeial, and industry standards.

• Collaborate with contract manufacturing/testing organizations and regulatory authorities.

• Support supplier audits, reagent management, and improvement of analytical processes.

What You Bring to Takeda

• Master’s degree in pharmaceutical science, biotechnology, chemistry, or related field.

• Minimum 5 years of leadership or project lead experience within QC or QA (oversight of QC activities).

• Strong expertise in analytical methods transfer, statistical data analysis, and cGMP compliance.

• Experience with vaccines and biologics manufacturing/testing in an outsourced environment preferred.

• Excellent communication skills; able to present complex technical concepts to non-technical audiences.

• Proactive, solution-oriented mindset with strong leadership skills in a matrix organization.

• Fluent in English (German is a plus).

• Six Sigma Lean Laboratory certification (Greenbelt/Blackbelt) preferred.

• Willingness to travel up to 20%.
  
  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.

• Empowering our people to shine:

  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, or any other characteristic protected by law.

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