Your (new) Opportunity:
- Supervision of the team members according to Business Ethics Takeda Corporation and continuous development (PMOs, training, mentoring, etc.)
- Motivation and encouragement of team members; balance workload among team members, strategic planning of department objectives in alignment with global objectives and procedures
- Preparation of Product Quality Reviews (PQR) and Yearly Biologic Product Reports (YBPR) in collaboration with global team for Vienna based products including monitoring of results
- Establish and maintain Site Master File content for Vienna
- Perform Regulatory Notifications process including tracking of post-licensing commitments
- Quality KPIs Preparation, moderation of the Vienna Quality Council and compilation of Vienna quality KPIs
- Assess regulatory inspection results across Takeda plants and collaborate at cross-functional and global level to develop action plans
- Develop strategies to systematically identify and address compliance gaps across the Vienna sites in close collaboration with the operating units
- Continuous improvement of processes and systems
Your Skills and Qualifications:
- Technical, pharmaceutical, chemical or biological college or university degree with practical experience of a quality operations function or related area
- More than 3 years experience in the pharmaceutical industry
- Strong communication and technical skills, responsibility, accuracy, reliability, strong analytical skills, negotiation skills, interpersonal skills and organizational skills
- Strong change management and people management skills are desirable, but this position also provides the opportunity for personal development into a supervisory role
- Excellent command of the English and German language (verbal and written)
- In depth knowledge of applicable regulations and laws for biological products, such as FDA CFR, cGMP, EU GMP, MD, EU Directives and guidelines
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 3.323,20 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.