Lead and scale the Computer System Validation capability across IT, defining validation strategy, operating model, and risk-based approach while building the CSV team.
Author, review, and execute validation lifecycle deliverables including validation plans, requirements, risk assessments, and test protocols.
Collaborate with Quality, IT, business owners, and vendors to translate compliance needs into practical, scalable validation strategies.
Plan and conduct GxP audits (internal, vendor, site) to ensure compliance with FDA regulations and GCP.
Develop risk-based audit plans, communicate observations, and track corrective actions until closure.
Escalate critical deficiencies to leadership and support inspection readiness through key staff interviews.
Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. As a subsidiary of McKesson, we bring together more than 1,300 physicians and have contributed to pivotal research that led to the majority of new cancer therapies approved by the FDA in the past decade.
Specify, design, develop, and implement Manufacturing Execution Systems (MES) for life sciences manufacturing environments.
Author and configure Electronic Batch Records (EBR) and ensure compliance with FDA and GMP guidelines.
Collaborate with business teams, mentor junior staff, and manage client relationships on international projects.
Accenture is a leading global professional services company that helps businesses, governments, and other organizations build their digital core and optimize operations. With approximately 791,000 employees serving clients in over 120 countries, Accenture fosters a culture of innovation and shared success.
Lead scientific validation and regulatory qualification strategies to accelerate adoption of Advanced Cell Models solutions.
Drive U.S. regulatory acceptance activities including FDA ISTAND Pilot Program and DDT qualification pathways.
Build scientific collaborations with key opinion leaders and academic institutions to strengthen external scientific credibility.
Sartorius accelerates the development and production of innovative therapies for better health. As a global life science company listed on the German DAX and TecDAX, they offer a wide range of benefits and a welcoming culture.
Lead end-to-end GCP auditing processes, including scheduling, conducting, reporting, and follow-up for sites, vendors, and internal processes globally
Apply deep knowledge of FDA, EU, and ICH regulations to independently resolve compliance issues and represent GDQA on cross-functional teams
Develop risk-based audit strategies, mentor new staff, and support regulatory inspections with 6+ years of experience including 4+ years direct GCP auditing
Regeneron is a leading biotechnology company that invents life-changing medicines for people with serious diseases. Founded and led by physician-scientists for over 30 years, we have developed nine FDA-approved treatments and numerous candidates, fostering a culture of innovation recognized as a Great Place to Work.
Provide high-level consulting services for statistical analysis, reporting, and programming in clinical trials.
Develop and validate statistical analysis plans, randomization schedules, and clinical trial reports.
Mentor statistical programmers and ensure compliance with regulatory guidelines like ICH, GCP, and 21 CFR Part 11.
eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. It is a fast-growing company that has won the 2025 Top Workplaces USA Award for Remote Work and emphasizes an inclusive culture and work-life balance.
Lead global pharmacovigilance audits, regulatory inspections, and readiness planning.
Oversee issue management, deviations, root-cause analysis, and CAPA activities.
Develop and manage the global pharmacovigilance training program and procedural documentation.
Our partner is a fast-growing biopharmaceutical company focused on improving outcomes for patients with severe autoimmune diseases. It offers a collaborative environment with opportunities for professional growth and leadership development.
Participate in CRF design, database review, and data validation procedures to ensure data integrity.
Produce data listings, summary tables, and graphics for interim and final analyses of clinical trials.
Collaborate with Biometrics functions and coordinate data transfer standards with CROs and vendors.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, they maintain a supportive culture focused on quality, professional development, and low turnover.
Oversee strategic and operational execution of clinical trials, leading cross-functional teams and managing vendor selection.
Direct clinical trial budgets, risk mitigation, and provide technical input into key clinical documents.
Mentor staff and foster strong team relationships in a dynamic organization.
Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. The company was launched based on assets licensed from Paragon Therapeutics and has a growing pipeline.
Conduct risk-based quality control assessments and on-site visits to ensure investigational sites adhere to study protocols, GCP, and company procedures.
Develop and maintain study-specific QC plans, tools, and reports, and drive trend analysis and issue resolution with clinical operations teams.
Support inspection readiness and contribute to training and process improvements based on QC findings and regulatory insights.
Zai Lab is a commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and worldwide. Founded in 2014, the company has a global team of about 2,000 employees, with a strong commitment to gender diversity and a culture that promotes women in biotech.
Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.
Lead quality assurance activities to support patient safety and pharmacovigilance compliance across global operations.
Plan, conduct, and manage pharmacovigilance audits, CAPA programs, and regulatory inspection readiness activities.
Collaborate with cross-functional teams including clinical development, regulatory affairs, and medical affairs to maintain robust quality systems.
This company is a science-driven healthcare organization focused on pharmacovigilance and patient safety. They operate in a collaborative, global environment committed to operational excellence and meaningful healthcare impact.
Set the strategic direction for Compliance Operations, transforming regulatory requirements into scalable practices that enable growth.
Partner with Product and Engineering to build tech-first, automated solutions that reduce manual effort and scale operations.
Lead state licensing audits, develop key compliance metrics, and build a high-performing team of 5-10 professionals.
Honor Technology is changing how society cares for older adults by providing technology, tools, and services that empower them to live life on their own terms. With over 100,000 Care Pros and a global franchise network, the company delivers over 50 million hours of personalized care annually, fostering a culture of innovation and compassion.
Seeking a POMS MES Techno-Functional Subject Matter Expert for pharmaceutical manufacturing (GxP).
Responsible for bridging business, quality, validation, and IT to configure and support MES solutions.
Ensures compliance and operational excellence while leveraging strong MES, EBR, and GMP experience.
The company is a staffing firm that places digital engineers in the pharmaceutical industry. It focuses on contract roles for MES and compliance projects.
Develop and lead the enterprise compliance program strategy and roadmap.
Serve as program manager for compliance buildout and commercialization-readiness initiatives.
Provide practical guidance on healthcare compliance risks related to commercialization.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. The company is guided by core values and committed to transforming treatment for autoimmune disease, fostering a culture of ethics and integrity.
Lead the IT SOX program, focusing on ITGC controls remediation and integration to ensure compliance.
Partner with IT and business teams to design, develop, and test internal controls while identifying process improvements.
Drive audit readiness, remediate control gaps, and maintain an effective control environment in a fast-paced setting.
HealthEquity empowers healthcare consumers to save and improve lives through HSA solutions and health spending accounts. The company is a growing, public organization with a culture of integrity and collaboration.
Provide quality oversight and direction to vendors to ensure cGMP compliance for clinical manufacturing.
Lead clinical lot disposition, batch record review, and QP certification for global trials.
Oversee GMP quality systems including deviations, investigations, and audits at contract manufacturing partners.
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. It is a small, lean organization within the Roivant family, focusing on collaboration and innovation.
Lead the full scope of Biostatistics activities for assigned clinical programs, including study design, analysis, and regulatory submissions.
Collaborate cross-functionally with Clinical, Medical, and Regulatory teams to ensure quality and timely delivery of statistical outputs.
Oversee CROs and internal teams, supervise statistical programming, and drive continuous improvement in biostatistics processes.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania and operates as a fully remote organization.
Independently conduct on-site and remote monitoring visits (SQVs, SIVs, IMVs, COVs) per protocols and regulations.
Manage site relationships, perform source data verification and review, and resolve data discrepancies.
Track monitoring findings, escalate risks, and maintain inspection-ready documentation.
Karius is a venture-backed life science company focused on clinical metagenomics, using genomics and AI to detect infectious diseases from microbial DNA in blood. The company is dedicated to advancing diagnostic science and improving patient care.
Develops and analyzes research data using statistical methods, assisting researchers with study protocols and computer analyses.
Manages computer systems, writes programs, and trains others in their use, providing statistical expertise in study design and data analysis.
Consults with investigators to determine research questions, performs appropriate statistical analyses, and documents methods and results in reports.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. It is a large institution with a diverse academic community, committed to equal opportunity and affirmative action.