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Clinical Trials Quality Compliance Specialist (m|w|d)

Miltenyi BiomedicineBergisch Gladbach, Germany

Vor 30+ Tagen

Stellenbeschreibung

Job Description

Your role

You are working in the “Clinical Research & Development” department which conducts first-in-man clinical trials and Phase I-II proof-of-concept studies for our new assets worldwide.

You ensure GCP compliance for the clinical trials in collaboration with Quality Assurance to support our department’s objectives in meeting and GCP-compliance by providing structure, identifying and supporting the resolution of issues on trial and process level through
With respect to our activities, you closely collaborate with the Quality Assurance department and cross-functional Clinical Research & Development teams to develop QA / QC measures
In addition you also plan and conduct activities related to compliance and inspection readiness, including quality checks of TMFs and processes. You review and improve processes for efficiency, effectiveness and compliance with regulations, guidelines, and quality policies and support site / CRO assessments.
You will also coordinate and support functional / clinical trial teams in audit / inspection activities to ensure a consistent approach / action across clinical trials and programs. To improve functional processes and foster a culture of continuous improvement, you identify, analyze, track and resolve findings, regulatory and process gaps / non-conformances.
By developing and implementing a lessons-learned culture, you help to improve the quality of processes and documentation (in compliance with regulations, guidelines, quality policies) and minimize associated trial risks.

Qualifications

You hold a Bachelor’s Degree or equivalent qualification in Life Sciences / Healthcare; Master's degree preferred.

You have several years of clinical / industry / health authority experience, including a strong focus on quality and compliance. You acquired a thorough knowledge of Good Clinical Practice, regulatory guidelines (FDA / EMA / ICH) and the clinical development process. In addition, you are experienced in audits or inspections (e.g. FDA, EMA).

You have strong analytical skills with attention to detail and are a problem solver. You are a highly motivated, open-minded team player with a proven ability to take initiative, prioritize and meet project deadlines in a dynamic environment.

You are naturally communicative and have effective communication (verbal and written) and organizational skills, both in English and German.

A sound knowledge of Microsoft and electronic clinical trial applications, e.g. eCRF, eTMF or CTMS, is expected.

Additional Information

Further information

This position is limited to 12 months.

What we offer

Working with free and self-determined time management, also mobile working

An intercultural environment characterized by diversity and flat hierarchies

Freedom to contribute creatively and play an active role in shaping the company

Individual further training in our Miltenyi University as the core of the Miltenyi DNA

30 days of vacation, discounted ticket to Germany, (e)-bike leasing, capital-forming

benefits, company pension plan, disability insurance, canteen, and much more.

Diversity is the bedrock of our creativity

Our mission : To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots – across various disciplines, linking different perspectives, skills, and abilities.

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability.

Become part of our team and focus on pushing the borders of medicine.

We look forward to your application

If you would like to work in an open, creative and helpful team, we offer you the right environment here. We look forward to receiving your application - with your salary expectations and availability.