Head of Glp/gcp QA

Vor 6 Tagen

Biberach an der Riß, Deutschland BI Pharma GmbH&Co.KG Vollzeit

**The Position**:
Work at the forefront of pharmaceutical innovation Bring in your experience and knowledge in our non-clinical health and safety studies by assuming Quality Assurance (QA) responsibility.
Lead, manage, and develop the Quality Assurance team within the Quality NCE department as part of Global Quality Development. Your expertise as the Head of Good Laboratory Practice / Good Clinical Practice is our key to success

***Tasks & responsibilities**:

- In your new role, you will design and continuously improve the Quality Management System for non-clinical good laboratory practice (GLP) and good clinical practice (GCP) activities within the GLP Test Facility Biberach, based on the applicable regulatory and internal company requirements.
- Moreover, you will ensure compliance with GLP, GCP and World Health Organization regulations as well as local regulatory requirements related to the performance of non-clinical studies in GLP and clinical study activities in GCP.
- In addition, you will give strategic direction and drive standardization, as well as the harmonization of global processes with other Boehringer Business units.
- Based on your experience and knowledge you will be responsible for planning, organizing, and directing regulatory activities. This includes the interaction with the local supervisory authority and hosting respective inspections.
- As an auditor or expert, you will furthermore participate in the performance of audits - internally and at third parties in cooperation with the functional Audit unit within Quality Development and other Boehringer Quality units. Your tasks will also include the planning of audits and the evaluation of audit results.In addition, you will represent Quality Assurance GLP / GCP in external, international, and inter-company committees.

**Requirements**:

- Master's degree in biology, veterinary, pharmacology, pharmaceutics or related field with several years of professional experience in GLP / GCP regulated environment, especially in the field of quality assurance
- Excellent knowledge of current GLP / GCP guidelines - national and international
- Several years of experience leading line or matrix teams with strong leadership skills and ability to provide direction in unusual situations
- Auditing skills and experience - in the direction of externals and internally with authority inspections
- Ability to drive and support change, solution orientation, sense of responsibility and entrepreneurial thinking
- Excellent communication skills coupled with intercultural skills and sensitivity
- Fluency German and English, spoken and written

***Ready to contact us?**:
Recruitment process:
Step 2: Virtual meeting mid-January
Step 3: On-site interviews February 10th & 11th 2025

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