Your Opportunity:

Performs protocols, study phases, raw data, amendment and final report audits of non-clinical, analytical  and bioanalytical  studies conducted in compliance with international and domestic GLP and OECD GLP regulations (in-house and multi-site as applicable)Provide stakeholders with subject matter expertise for GLP quality/compliance recommended corrective actions and issue resolutionsPerforms internal quality system inspections (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance.Independently perform qualification audit of subcontractors and suppliersParticipate in regulatory inspections and inspection readiness activitiesMaintain GLP training program to ensure that personnel are appropriately trained to carry out GLP responsibilities  Reviews and audits compliance documents, SOPs, and protocols in support of test facilities GLP regulated activitiesSupports other quality GLP and QMS related activities as assigned

Your Skills and Qualifications:

Bachelor's degree in a scientific field (or a combination of education and experience)Minimum 5-7 years of experience in GLP compliance/ QA in a pharmaceutical or biotech industryPrevious work experience in internal/ external domestic and international GLP auditing requiredAnalytical auditing background desiredExperience in training initiatives Good knowledge of international regulatory requirements and industry guidelines for global GLPAbility to identify issues and offer solutions in a pragmatic wayGeneral knowledge of drug development processExcellent written and verbal communication skills in German and EnglishExcellent business skills such as critical thinking, strategic planning and self-management

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.

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 € 4.369,11 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.