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Research Quality Assurance Lead und Auditor (f/m/d), Hybrid

Vienna, Vienna
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  • Job Type: Full Time
  • Job Level: Senior
  • Travel: Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

Job ID R0107609 Date posted 10/02/2023 Location Vienna, Vienna

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

The main responsibility is maintaining and supporting the quality oversight of the GLP QA program of Takeda´s GLP Test Facility in Vienna.

This role includes leading internal and external (supplier) quality audits to assess quality management systems, adherence to applicable regulations/procedures and appropriateness for use by quality standards

How you will contribute:

  • Provide GLP quality oversight and ensure a state of compliance for internal GLP activities within the GLP Test Facility Vienna

  • Perform protocol, study phase, raw data, amendment and final report reviews and audits of non-clinical studies conducted in compliance with international and domestic GLP and OECD GLP regulations (in-house and multi-site as applicable)

  • Perform internal process and facility based audits (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance.

  • Provide stakeholders with subject matter expertise for GLP quality/compliance CAPA process

  • Participate in regulatory inspections and inspection readiness activities

  • Maintain GLP training program to ensure that personnel are appropriately trained to carry out GLP

  • Review and audit documents, SOPs, computerized systems, and in support of GLP test facility regulated activities for compliance

What you bring to Takeda:

  • Bachelor’s degree in a scientific field (or a combination of education and experience)

  • Minimum 5-7 years of experience in GLP, GCLP compliance/ QA in a pharmaceutical or biotech industry

  • Previous work experience in internal/ external domestic and international GLP auditing required

  • Experience in training initiatives

  • Good knowledge of international regulatory requirements and industry guidelines for global GLP, GCLP

  • Ability to identify issues and offer solutions in a pragmatic way

  • General knowledge of drug development process

  • Excellent written and verbal communication skills in German and English

What Takeda can offer you:

A competitive remuneration package with a minimum salary of € 5.222,35 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.

  • Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten

  • Work @ home depending on the position / department

  • 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

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.

Locations

AUT - Wien - Industriestrasse 67

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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We are living in a big world, interdependent on one another. It's important to have a global view and global mindset.

Lin Wang - Takeda Development Center Asia

Takeda is an outstanding company for anyone interested in exploring new areas or expanding their knowledge base. During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.

Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations

When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.

Meredith Culp - GPM Head & Chief of Staff, Neuroscience Therapeutic Area

The heart of our work

Shining a light on new perspectives

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

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 15 companies to receive Top Global Employer® status for 2023.
  • 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.

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