- 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 resolutions
- Performs internal quality system inspections (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance.
- Independently perform qualification audit of subcontractors and suppliers
- Participate in regulatory inspections and inspection readiness activities
- Maintain 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 activities
- Supports 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 industry
- Previous work experience in internal/ external domestic and international GLP auditing required
- Analytical auditing background desired
- Experience in training initiatives
- Good knowledge of international regulatory requirements and industry guidelines for global GLP
- 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
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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.