You lead the development of quality strategies and auditing processes, adapting to regulatory changes while maintaining strong partnerships and ensuring inspection readiness across various therapeutic areas.
Anforderungen
- •Bachelor's degree required
- •Minimum 5-7 years QA experience
- •Broad working knowledge of GxP disciplines
- •In depth knowledge of drug development process
- •Fluent in written and spoken English
Deine Aufgaben
- •Develop and implement quality strategies for specific therapeutic areas.
- •Design and execute risk-based auditing and quality oversight.
- •Continuously adapt strategies to meet changing regulations.
- •Provide strategic direction for health authority inspections and audits.
- •Build strong partnerships with stakeholder groups.
- •Ensure ongoing inspection readiness with GCP and GVP expertise.
Deine Vorteile
Diverse backgrounds and perspectives
Commitment to excellence and innovation
Opportunities for personal growth
Culture of inclusion and belonging
Original Beschreibung
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# Quality Strategy Lead (all genders)
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
**Your role:**
The Quality Strategy Lead (QSL) for Post-Marketing is responsible for developing and implementing comprehensive quality strategies for the designated Therapeutic Area or Business area. This role involves designing and executing a risk-based auditing and quality assurance oversight strategy that encompasses regulated activities, including observational/non-interventional studies, disease/drug registries, epidemiology studies, patient support programs, health outcomes, and real-world data usage, along with functional QA support.
As standards and circumstances evolve, you will continuously assess and adapt your approach to align with the organization's changing needs and regulatory landscape. The QSL will also play a key role in providing strategic direction for the preparation, execution, and closure of health authority inspections and external audits in collaboration with the Inspection Management Group. Building strong partnerships with stakeholder groups is essential, as is providing GCP and GVP expertise to ensure ongoing inspection readiness within your area of responsibility.
**Who you are:**
* Bachelor in scientific or quality-related subjects required. Advanced degree desirable. Equivalent relevant experience maybe considered
* Minimum 5-7 years QA experience or relevant experience in pharmaceutical and/ or biotech industry, in particular clinical quality management, PV quality management, biomedical science, clinical development, or regular compliance with a minimum of 5 years in Clinical / Medical QA
* Broad working knowledge of other GxP disciplines like Medical Devices, GMP or Good Data Management
* In depth knowledge of drug development process and international GCP regulations and pharmacovigilance guidelines
* Fluent in written and spoken English
**What we offer:** We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Job Requisition ID:
288950
Location:
Darmstadt
Career Level:
D - Professional (4-9 years)
Working time model:
Full-time
**North America Disclosure**
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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QA, Quality Assurance, R&D, Pharmaceutical, Medical Device, Quality, Technology, Research, Science, Healthcare