It qa quality assurance associate director

IT QA Quality Assurance Associate Director IT QA Quality Assurance Associate Director Get AI-powered advice on this job and more exclusive features.
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Senior Director, Talent Access International at Madrigal Pharmaceuticals IT QA Associate Director
About 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 Summary
This 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 Assurance
Provide quality assurance oversight for internal GxP-regulated IT systems across US, EU, and Swiss operations to ensure full compliance with region-specific regulatory standards
Lead 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 platforms
Partner with IT and business stakeholders to integrate quality oversight into SDLC activities and oversee periodic review programs, ensuring consistent compliance across functional areas
Maintain inspection readiness by proactively identifying and remediating compliance gaps, ensuring adherence to 21 CFR Part 11, EU Annex 11, and GAMP guidance for IT systems
Drive strategic enhancements to the IT QA framework by identifying process inefficiencies and implementing scalable improvements aligned with evolving regulatory and business needs
Mentor cross-functional teams in validation best practices while influencing executive decision-making through clear, data-driven communication and quality-driven leadership
Responsibilities:
Influence strategy and accountable for technology related qualifications/ validation planning documents and associated deliverables
Ensure recommended changes/improvements to support the Enterprise Systems, including serialization technology platforms, are compliant to the internal and external policies, processes, and procedures
Collaborate with IT team members in supporting System Development Lifecycle (SDLC)activities requiring quality oversight
Accountable 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 activities
Partner with Business Owner and IT Technical Owners to lead system Periodic Review Program
Provide 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 EU
Ensure that IT and Business areas remain current with company policies/procedures, industry standards, and FDA/ EU regulations
Maintain required knowledge of applicable regulations, guidelines, and company standards and procedures
Lead IT QA preparations for (corporate and third-party) inspection-readiness. Identify and propose remediation for any compliance gaps
The Candidate
Experience and Professional Qualifications
The 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 industries
BS and/or MS in a scientific or technology discipline
In-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 guidance
Firsthand 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 technologies
Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications designed for commercialization
Knowledge of FDA regulations and ICH Guidelines, particularly those affecting IT systems, in the US/EU pharmaceutical and/or biotech manufacturing environments
Experience in using and/or implementing System Development Lifecycle and testing tools
Cross-Functional Collaboration:
Communication & Influence
Problem Solving & Analytical Thinking
Change Management & Process Improvement
Aptitude for identifying inefficiencies and driving process improvements within IT QA frameworks
Attention to Detail & Documentation Rigor
Additional Information
Madrigal 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 level Seniority level Director
Employment type Employment type Full-time
Job function Job function Quality Assurance and Information Technology
Industries Pharmaceutical Manufacturing
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