Research Quality Assurance Lead und Auditor (f/m/d), HybridVienna, Vienna
- 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.
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
Free vaccination program
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.
LocationsAUT - Wien - Industriestrasse 67
Time TypeFull time
The heart of our work
Shining a light on new perspectives
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough 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
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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