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**About the role**:
**How you will contribute**:
- Leadership of Plasma OpU above-site projects: owning and driving any GMP, Quality or compliance activities / projects as required
- Managing Supplier Quality, including SNC (Supplier Notification of Change) process
- Regulatory submission support for CMO manufactured products
- Managing local Risk Register
- Owning or QA approve Change Controls and Deviations
- Manage / support KPIs and Quality Council
- Operational tasks for Quality Systems and Compliance in ESPQ
- Product Quality Reviews (PQRs)
- Supporting any GMP, Quality or compliance activities as required
**What you bring to Takeda**:
- At least 5 to 7 years’ experience in a Quality / Compliance related position within the pharmaceutical or life-science industry, preferentially in plasma products.
- Minimum requirement of a Bachelor degree or University studies in Sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, Biotechnology, Natural science etc.).
- Strong experience and skills in cGMP and Quality Management.
- Strong track record of identifying and correcting compliance issues and implementing process improvements.
- Knowledge and understanding of cGMP (EU / US as applicable) regulations with respect to the production and testing of pharmaceutical and / or biological products as applicable.
- Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors.
- Well-established experience in risk management and project management.
**What Takeda can offer you**:
A competitive remuneration package with a minimum salary of € 4.751,92 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
**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 - DC Tower
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time