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Healthcare Businesswomens Association
Director, Global TRD QA Sterility Assurance
• AT- 7 Schaftenau
Führungs-/ Leitungspositionen
Salary Range: 0.00-0.00 Job Description Summary Location: Schaftenau, Austria Role Purpose: Establish, lead, and continuously develop the TRD QA Sterile
Operations Network, fostering accountability, learning, and collaboration. Provide
MEHR INFOS ZUM STELLENANGEBOT
[...] class=highlight_text>specialist knowledge and guidance on sterile and low bioburden processes, ensuring compliance with regulatory requirements. Implement, harmonize, and continuously improve aseptic standards and best practices across TRD pilot plants and across all modalities (Cell and Gene Therapies, Radioligand Therapies, ADC, and New Biological Entities) . Drive continuous improvement, knowledge transfer, and [. .. ] pushback diplomatically. Political savvy-navigate informal networks and overcome barriers to secure a seat at the table. Qualifications Advanced degree (Ph D, MSc, or equivalent) in life sciences, pharmacy, or related
field Extensive experience in sterile manufacturing, quality assurance, or related areas within the pharmaceutical/ biotech industry Strong knowledge of aseptic processing, sterility assurance, and regulatory requirements (e. g. , FDA, EMA, ICH) Proven track record in leading cross-functional teams or networks, ideally in a matrix environment Demonstrated ability to influence [. .. ]
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