For our client, an international pharma company in Basel, we are looking for a highly motivated and experiencedTechnical QA Managerto join a dynamic IMP Quality Systems and Qualification/Validation team.Thr IMP Quality Systems and Qualification/Validation team plays a key role in ensuring GMP compliance of facilities and systems used for the manufacture of Investigational Medicinal Products (IMPs). The team covers production facilities for the chemical synthesis of small molecules and nucleotides, solid dosage formulation, sterile filling, packaging and analytics, and CSV systems. We are looking for someone who canprovide technical QA oversightand contribute to maintaining the highest quality standards.General Information:Start date: as soon as possibleLatest start date: Planned duration: until end of 2029Contract: temporary via RandstadWorkplace: BaselWorkload: 60-80%Home Office: possible upon discussionWorking hours: StandardTasks & Responsibilities:QA oversight of qualification and validation activities for GMP-relevant facilities and systems in drug substance and/or drug product manufacturing.QA oversight of CSV systems.Support the implementation of data integrity requirements.Review and approve GMP documents (e.g., qualification plans, reports, change and deviation management, CAPAs, SOPs, risk analyses).Conduct in-depth root cause analyses to resolve complex problems.Drive optimization and improvement activities within IMP Quality.Collaborate with stakeholders and contribute to the achievement of common goals.Represent the area of ??responsibility during inspections by health authorities and internal audits.Support end-to-end cGMP activities and maintain the Right to Operate.Must Haves:Academic degree in engineering, chemistry, life sciences, pharmacy, or comparableFluent in German and EnglishAt least 5 years of professional experience in the pharmaceutical industry, including at least 2 years in quality assuranceAt least 3 years of experience in facility qualification/validationUnderstanding of current data integrity (DI) requirementsKnowledge of global quality and GMP requirementsProven success in inspections by health authorities and internal GMP auditsStrong team player with excellent communication and influence skillsNice to Haves:Experience in sterile and/or low-germ manufacturing of pharmaceuticalsExperience in the analysis of synthetic molecules and drug productsExperience with Veeva QMS, eVAL, and ELVIS