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Job Description

About the Role:

• Provide global GxP Quality oversight of laboratory activities (method development, validation, release, stability) across modalities.
• Ensure implementation and execution of data integrity and quality system standards in internal and external laboratories.
• Partner with cross-functional teams to support analytical lifecycle management and regulatory submission readiness.
• Lead key quality initiatives and investigations related to laboratory operations.

How you will contribute:

ACCOUNTABILITIES

• Provide quality oversight for internal GxP and non-GxP laboratories performing analytical activities across the R&D pipeline.
• Review and approve GMP/GLP documentation including method validation protocols/reports, deviations, CAPAs, and audit responses.
• Ensure appropriate implementation of ALCOA+ principles and data integrity controls in laboratory systems and workflows.
• Lead or support laboratory-related investigations and inspections, ensuring timely root cause analysis and sustainable CAPA.
• Collaborate cross-functionally with Pharmaceutical Sciences, Regulatory Affairs, Manufacturing, and other Quality functions.
• Participate in the preparation and review of analytical sections for regulatory filings (IND/CTA/NDA/BLA).
• Contribute to the development and improvement of global procedures, standards, and quality frameworks for laboratory oversight.
• Monitor quality performance trends and proactively escalate compliance risks or improvement opportunities.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Strong understanding of GxP regulations, analytical methods, and laboratory operations across modalities (small molecules, biologics required; cell/gene therapy, plasma, or vaccines a plus).
• Demonstrated application of data integrity principles and computerized system controls in laboratory environments.
• Experience with internal and external laboratories, technical agreements, and audit preparation.
• Proficiency in quality risk management, deviation handling, and CAPA effectiveness.

Leadership

• Supports strategic goals of the R&D GMP Quality organization.
• Coaches junior team members or cross-functional partners on quality principles.
• Effectively communicates quality expectations and analytical requirements.
• Influences decision-making in cross-functional settings and supports change management efforts.

Decision-making and Autonomy

• Exercises judgment in resolving laboratory-related quality events and compliance issues.
• Makes independent decisions within the scope of analytical QA responsibilities.
• Provides recommendations for quality risk mitigation and system improvements.

Interaction

• Collaborates with Analytical Development, QC, Manufacturing, Regulatory, and QA teams.
• Interfaces with external laboratories and CMOs as required.
• Participates in regulatory inspections, audits, and governance meetings.

Innovation

• Contributes to process improvements and implementation of digital solutions.
• Promotes knowledge sharing and continuous improvement culture within the team.
• Identifies new tools or practices to enhance laboratory compliance and efficiency.

Complexity

• Supports laboratory oversight across a range of modalities and global sites.
• Navigates matrixed organizational structures and diverse cultural and regulatory landscapes.
• Balances scientific, compliance, and business needs in decision-making.

What you bring to Takeda:

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field. Preferred advance degree (MS/PhD)
• 7+ years of relevant industry experience in quality oversight of laboratory operations
• Demonstrated experience in GMP/GLP, analytical testing, data integrity, and regulatory inspections
• Strong interpersonal, project management, and problem-solving skills
• Ability to operate in a global matrix environment and manage competing priorities

What we offer you:

• A competitive remuneration package with a minimum salary of € 5.598,85 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary is higher and depends on your professional experience and qualifications.
• Short term incentive and long term incentive
• Family-friendly company environment; support with parental leave, dad month, Bilingual company kindergarten
• Work@home depending on the position / department
• Commuting allowance or parking space (tax applicable) 
• Comprehensive training programs
• In-house job rotation program
• In-house Canteen with discounts or meal vouchers
• Works council (events, festivals, shopping vouchers, etc.)
• Employee Referral Program
• Employee Recognition Program
• Takeda Resource Groups
• Medical checkups
• Free vaccination program
• Fitness Center
• Employee discounts 
• Employee Stock Purchase Plan
• Group accident insurance 

More About Us:

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 240 years of distinguished history in Japan.

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.

Make History, Change Futures.

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, the organization spans the globe—colleagues across business units and functions face challenges head-on to deliver on our vision. The omnipresent patient focus instills pride in personal contributions.

How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, 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. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process. 

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