IT QA Quality Assurance Associate DirectorIT QA Quality Assurance Associate DirectorGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Madrigal PharmaceuticalsSenior Director, Talent Access International at Madrigal PharmaceuticalsIT QA Associate DirectorAbout Madrigal:Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.’Position SummaryThis position will be responsible for Quality Assurance in the Technology space at Madrigal and will partner with IT and Business areas to provide quality oversight for internal computer systems validation lifecycle. The role includes quality oversight of external serialization systems and internal IT quality processes applicable to both the US and EU. The position will support a culture of building Quality principles into solutions and recommend change/improvements to support Madrigal’s internal Enterprise Systems, and ensure systems are compliant to internal and external policies, processes, procedures, and regulatory requirements.This position reports into the Vice President of Global Quality AssuranceProvide quality assurance oversight for internal GxP-regulated IT systems across US, EU, and Swiss operations to ensure full compliance with region-specific regulatory standardsLead the development, review, and approval of computer system validation documentation (e.g., protocols, test plans, validation reports) to support risk-based lifecycle management of enterprise platformsPartner with IT and business stakeholders to integrate quality oversight into SDLC activities and oversee periodic review programs, ensuring consistent compliance across functional areasMaintain inspection readiness by proactively identifying and remediating compliance gaps, ensuring adherence to 21 CFR Part 11, EU Annex 11, and GAMP guidance for IT systemsDrive strategic enhancements to the IT QA framework by identifying process inefficiencies and implementing scalable improvements aligned with evolving regulatory and business needsMentor cross-functional teams in validation best practices while influencing executive decision-making through clear, data-driven communication and quality-driven leadershipResponsibilities:Influence strategy and accountable for technology related qualifications/ validation planning documents and associated deliverablesEnsure recommended changes/improvements to support the Enterprise Systems, including serialization technology platforms, are compliant to the internal and external policies, processes, and proceduresCollaborate with IT team members in supporting System Development Lifecycle (SDLC)activities requiring quality oversightAccountable for providing insight on IT QA Project deliverables for GxP technology systems including generation of change controls, interaction with IT personnel and vendors, review of change plans and Configuration Specification(s)Generate, review and/or approve lifecycle deliverables including but not limited to Test Plans/Protocols, Executed Testing Summaries, Vendor or internally developed Functional specs, Configuration or Design related deliverables, Validation Summary Report(s), and any applicable artifacts to support validation activitiesPartner with Business Owner and IT Technical Owners to lead system Periodic Review ProgramProvide guidance/oversight on SOPs and Policies (i.e. System Use, System Admin, User Access) including those related to serialization compliance and IT processes in the US and EUEnsure that IT and Business areas remain current with company policies/procedures, industry standards, and FDA/ EU regulationsMaintain required knowledge of applicable regulations, guidelines, and company standards and proceduresLead IT QA preparations for (corporate and third-party) inspection-readiness. Identify and propose remediation for any compliance gapsThe CandidateExperience and Professional QualificationsThe successful candidate for the position of IT QA Associate Director will possess the following:Minimum of 10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industriesBS and/or MS in a scientific or technology disciplineIn-depth knowledge of cGMP regulated related to Computer System Validation, including, 21 CFR Part 11, current GXP Regulations, Annex 11 and GAMP, and current global technology related regulations and guidanceFirsthand experience in technology quality role using modern, Risk Based Computer Validation approaches in the life sciences industry for standard technology stacks (ERP, QMS, Doc Management, Learning Management, Infrastructure, Clinical Trial, PV, etc) as well as emerging technologiesKnowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications designed for commercializationKnowledge of FDA regulations and ICH Guidelines, particularly those affecting IT systems, in the US/EU pharmaceutical and/or biotech manufacturing environmentsExperience in using and/or implementing System Development Lifecycle and testing toolsCross-Functional Collaboration:Communication & InfluenceProblem Solving & Analytical ThinkingChange Management & Process ImprovementAptitude for identifying inefficiencies and driving process improvements within IT QA frameworksAttention to Detail & Documentation RigorAdditional InformationMadrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.Seniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionQuality Assurance and Information TechnologyIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Madrigal Pharmaceuticals by 2xGet notified about new Information Technology Quality Assurance jobs in Zug, Zug, Switzerland.Don't see what you are looking for? (Zurich location)Senior Release Test Engineer 100% (f/m/d)(Senior) Design Quality Assurance EngineerQuality Assurance Automation Engineer (Zurich, Vienna or Remote)Senior Test Engineer with test management skillsQA Automation Engineer - Crypto Market Making, LinearQA Automation Engineer - Crypto Market Making, LinearWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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