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Quality Assurance Expert

Neuchâtel, Canton of Neuchâtel
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On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

  • Small Molecules
  • Biologics
  • Plasma
  • Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0143904 Date posted 02/17/2025 Location Neuchâtel, Canton of Neuchâtel

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Job Description

About the Role: The Quality Assurance Expert is responsible for ensuring compliance and quality oversight throughout the manufacturing and release process of Drug Product (DP). This role plays a critical part in maintaining the highest standards of Good Manufacturing Practices (GMP), working collaboratively with various departments to ensure product integrity and regulatory adherence.

How You Will Contribute:

  • Act as QA representative for routine GMP activities and company projects (including the implementation of a new manufacturing area)
  • Ensure compliance with internal procedures, regulatory requirements, and industry best practices
  • Lead and review deviation investigations, impact assessments, and corrective/preventive actions (CAPA)
  • Evaluate and approve change controls, ensuring smooth implementation and compliance
  • Provide quality oversight by supporting and guiding production teams directly on the shopfloor
  • Conduct internal GMP audits and participate in regulatory inspections
  • Prepare, evaluate, and approve controlled documents (SOPs, forms, specifications, etc.)
  • Participate in batch record review and release activities
  • Support continuous improvement initiatives and contribute to operational efficiency
  • Provide training on GMP, GDP, and quality-related topics

Skills and Qualifications:

  • Bachelor/Master’s degree in Engineering, Biotechnology, Pharmacy, or Quality Management
  • 2-5 years of experience in a GMP environment within the pharmaceutical or biotechnological industry
  • Strong understanding of GMP, FDA, EMA, ICH, and Pharmacopeia regulations
  • Experience in auditing, inspection preparation, and deviation management
  • Knowledge of biotechnological processes and manufacturing operations, and more specifically aseptic process
  • Proficiency in MS Office; experience with quality systems such as TrackWise, Veeva and PAS-X is a plus
  • Fluent in French; intermediate level in English

Personal Attributes:

  • Detail-oriented with strong analytical skills
  • Structured, organized, and able to manage priorities in a fast-paced environment
  • Proactive and solution-oriented mindset with a continuous improvement approach
  • Excellent communication skills, able to adapt to different stakeholders
  • Team player, fostering collaboration across departments

Complexity and Problem Solving:

  • Participate in operational decision-making
  • Evaluate change requests and deviations in alignment with regulatory requirements and internal procedures
  • Ensure compliance with validation reports, SOPs, and industry regulations

Why Join Us? At Takeda, we are dedicated to transforming patient care through innovative medicines and first-class support programs. As a Global Top Employer, we offer stimulating careers, encourage innovation, and uphold excellence in everything we do. Our inclusive and collaborative environment empowers employees to thrive and contribute to a brighter future for all.

Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Exterior of Takeda Building

About our location

Neuchâtel, Canton of Neuchâtel


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