Quality Assurance Manager – German Speaking- 6919Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.For our clients Global Clinical Supply (GCS) who manages the packaging, labeling and worldwide distribution of clinical finished goods, we are looking for a QA Manager on a temporary basis and ensure that all GCS activities meet cGMP standards. You will provide quality oversight for clinical supply activities and contribute to the timely delivery of materials for global trials.This role is 6 months contract with chances of extension to be based in Basel. In this role, we are looking for fluent English and german speaking candidates.Main Responsibilities:· Batch release of clinical supplies (packaged and labeled finished goods, materials, and components), including review and approval of GMP documentation and issuance of batch certificates.· Deviation, and incident management: evaluation, QA oversight, support to investigations, and approval of records.· Change control management for GCS processes and documentation.· Write, review, and approve GMP-relevant documents (SOPs, CoAs, risk assessments, checklists, packaging & labeling documentation).· Support audits and inspections for TRD GCS topics.· Provide QA support for GCS operations and ensure alignment with TRD QA standards.Qualifications and Experience:· Relevant working/residency permit or Swiss/EU-Citizenship required· Master's degree in life sciences or equivalent education.· 3-5 years of Pharma QA experience, ideally in development, manufacturing, packaging, or clinical supply.· Strong knowledge of cGMP and QA processes (batch release, deviations, changes).· Hands-on experience with SAP (materials management, batch records, release workflows).· Experience with 1QEM is a strong asset.· Excellent communication and decision-making skills.· Fluent German and English (oral & written).Nice to have:· Experience in packaging and labeling operations or in global clinical supply chains.· Experience collaborating with CMOs or external partners.Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.
