Quality Assurance Research Program Lead Vienna

vor 2 Wochen

Wien, Österreich Takeda Pharmaceutical Vollzeit

**About the role**:
The **Quality Assurance Research Program Lead **is in charge of maintaining and supporting the quality oversight of the GLP & GCLP QA program of Takeda´s GLP Test Facility in Vienna and the QA oversight of GLP regulated activities in R&D. Additionally he will support non-GxP R&D areas and provide Quality oversight for submission relevant activities/data.

**How you will contribute**:

- Provide GLP and GCLP quality oversight and ensure a state of compliance within the GLP test facility Vienna
- Perform protocol, study phase, raw data, amendment and final report reviews and audits of non-clinical virus reduction studies conducted in compliance with international and domestic GLP and OECD GLP regulations
- Perform internal process and facility based audits (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance
- Review and audit compliance documents, SOPs, and protocols in support of GLP test facility regulated activities
- Participate in regulatory inspections, inspection readiness activities and agency inspections as needed
- Coordinate and review all responses to regulatory agency inspections and corrective actions commitments, ensure that timely responses are generated
- Establish and maintain relationships with Research QA stakeholders to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs
- Support implementation of GLP test article testing in R&D non-GxP labs
- Audit CoTs of GLP test articles
- Perform protocol and Data Integrity reviews, assessments and audits
- Lead internal and external (supplier) quality audits to assess quality management systems, adherence to applicable regulations/procedures and appropriateness for use by quality standards
- Provide oversight of external service providers conducting GLP study activities and external analytical regulated laboratory activities
- Independently perform qualification audits of suppliers
- Participate in agency inspections as needed. Coordinate and review all responses to regulatory agency inspections and corrective actions commitments, ensure that timely responses are generated
- Assist in the data collection for key performance indicators (KPIs) and quality metrics for quality to drive process improvements

What you bring to Takeda:

- Bachelor's degree in a scientific field
- Minimum 7 years of experience in GLP compliance/ QA within a pharmaceutical or biotech industry environment
- Previous working experience in internal/ external domestic and international GLP auditing required
- Analytical auditing background desired
- Experience in CS validation
- Good knowledge of international regulatory requirements and industry guidelines for global GLP and data integrity
- 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
- Excellent business skills such as critical thinking, strategic planning, and self-management

**What Takeda can offer you**:
A competitive remuneration package with a minimum salary of € 4.527,78 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
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
- In-house cleaning service

**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**:
Re

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