Specialist Quality Control GCP (m|w|d)
Miltenyi Biomedicine is a newly established international biopharmaceutical company that develops innovative cell and gene therapies. We are focused on bringing cancer treatments and regenerative therapies to patients. Our initial focus is on difficult to treat hematological cancers using CAR and TCR T cells whilst exploring treatments for solid tumors. We are currently in discussion with the FDA, EMA and Japanese health authorities regarding initiating pivotal Phase II trials. We strongly believe that despite promising developments, there is significant room to improve on current cancer therapies.Your role
You are working in the newly founded department Clinical Operations which is globally performing first-in-man and Phase I-II Proof-of-Concept cell therapy clinical trials for our new assets.
You support our department’s objectives in meeting quality and compliance by identifying and implementing process improvements by:
- Closely interacting with our Quality Assurance Department aligning your activities with the development of QA/QC measures together with cross-functional clinical trial teams,
- Planning and conducting activities related to compliance/inspection readiness such as
- quality checks of TMFs and processes in collaboration with line function heads to ensure correctness of documentation,
- reviewing and improving processes with respect to efficiency, effectivity and compliance with regulations, guidelines, and quality policies,
- supporting, planning or conducting Site/CRO assessment visits, as required,
- coordinating and supporting functional/clinical trial teams in audit/inspection activities to ensure consistent approach/measures across clinical trials and programs,
- identifying, analyzing, tracking and resolving findings, regulatory and process gaps/non-conformances which warrant the improvement of functional processes.
- maintaining an effective clinical trial team training system together with your supervisor and QA team.
What we offer
- You achieved a Bachelor’s Degree or equivalent qualification in life sciences/healthcare; Master’s degree is preferred.
- You demonstrate clinical/industry/health authority experience for at least 5 years, including a focus on quality and compliance preferably for at least 3 years.
- You acquired a thorough knowledge of Good Clinical Practice, regulatory guidelines (FDA/EMA/ICH) and the clinical development process.
- You are experienced in audits or inspections (e.g. FDA, EMA) and have strong analytical skills with attention to details.
- You have demonstrated a strong ability to prioritize and to achieve project timelines in a dynamic environment.
- You are naturally communicative in both English and German (verbal and written) and habe pronounced organization skills. A sound knowledge of Microsoft Office and electronic clinical trial applications, e.g. eCRF, eTMF or CTMS, is expected.
- A modern workplace and exciting opportunities in the development of technologies with a secure future
- Cross-border intercultural cooperation and short communication channels
- A collegial corporate culture and flexible working hours enable time management on your own terms
- Personalized employee development program: specialist and personal training courses provided by our own training academy