Source Job

• Performing testing activities end-to-end, identifying control gaps for remediation and acting as a subject matter expert in both IT and regulatory risk.
• Partnering with Operations, Compliance, Information Security, Engineering, Product, and Legal teams to translate complex regulatory requirements into actionable technical processes.
• Collaborating with risk owners to provide credible challenge to remediation plans and track findings using GRC tools (Audit Board).

Anchorage Digital is building the world’s most advanced digital asset platform for institutions to participate in crypto. They enable institutions to participate in digital assets through custody, staking, trading, governance, settlement, and security infrastructure. With over 600 employees, their team is united in building the future of finance by providing the foundation upon which value moves safely in the new global economy and are funded by leading institutions including Andreessen Horowitz, GIC, Goldman Sachs, KKR, and Visa, with its Series D valuation over $3 billion.

• Lead and execute internal audits across GMP, GCP, and GPV systems.
• Conduct GxP audits in accordance with applicable regulatory requirements.
• Oversee the GxP vendor and supplier management program.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.

• Part of the Veeva Development Team within the Information System organization.
• System administrator in the Veeva Quality and Regulatory systems.
• Hands-on role combining system administration, configuration, solution design, and system evolution within the Veeva Development Cloud ecosystem.

Sobi redefines the standards of care and transforms the lives of people living with rare diseases. They are a diverse team of entrepreneurial people, with over 1,900 employees in more than 30 countries, passionate about growth towards becoming a global leader.

• Leading internal operations and the office IT team.
• Owning the internal systems and SaaS ecosystem.
• Driving compliance and governance.

TrustYou is an AI-driven hospitality platform dedicated to transforming guest experiences. With a multicultural team of over 120 professionals working remotely across the globe, they help companies grow by achieving customer excellence, embracing an open feedback culture.

• Support site initiation, management, and close-out activities.
• Ensure trial conduct complies with protocol and regulatory requirements.
• Participate in data review and support site readiness.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease by staying true to their values and innovating boldly.

• Partner with Regulatory Affairs and Quality Assurance teams to create software validation processes.
• Coordinate software testing efforts within and across teams.
• Support recruitment, technical staffing, and organizational design to grow the testing team.

Freenome is a company focused on early cancer detection through innovative diagnostic products that leverage their engineering software platform. They are a high-profile tech organization experiencing rapid growth, valuing diversity, and committed to equal opportunity.

• Monitor updates to EP, USP, Mexico Ph, ChP, and JP.
• Analyze changes in compendial requirements.
• Ensure timely implementation of compendial changes.

Vertex Pharmaceuticals is focused on the discovery, development and commercialization of medicines. They strive to transform the lives of people with serious diseases.

• Lead the development of executive-level reporting on IT risk and compliance.
• Own and evolve the firm’s IT risk register and Risk & Control Self-Assessment (RCSA) program.
• Analyze incident, change, and problem management data to identify trends and improvement opportunities.

Wilson Sonsini is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. The firm has approximately 1,100 attorneys in 17 offices and fosters an entrepreneurial spirit and team-oriented approach for all employees.

• Own, manage, and continuously refine validation processes across all stages of the delivery lifecycle, ensuring that data and product outputs meet defined quality standards
• Partner with Data Science, Panel On Demand, and Discover teams to design, implement, and enforce quality tollgates that support consistent, repeatable delivery
• Lead and coordinate UAT activities, including test planning, execution, documentation, and stakeholder review ceremonies

NIQ is the world’s leading consumer intelligence company, delivering the most complete understanding of consumer buying behavior and revealing new pathways to growth. NIQ is an Advent International portfolio company with operations in 100+ markets, covering more than 90% of the world’s population.

• Track and drive audit partners through the onboarding and enablement lifecycle; maintain internal trackers and coordinate across teams.
• Keep the auditor directory accurate and current; verify accreditation status and update partner profiles.
• Assist the SME in mapping audit evidence requirements to platform capabilities; prepare reference data and document findings.

Sprinto is an AI-native GRC platform that helps organizations manage risks, audits, vendor oversight, and continuous monitoring from a single connected platform. With a team of 350+ employees serving 3,000+ customers across 75+ countries, they combine scale with expertise to deliver trust and compliance.

• Define and evolve security governance and risk management strategy, aligning function-level priorities with enterprise objectives and the security roadmap.
• Lead security-related audits, assessments, and regulatory inquiries in partnership with Legal, Compliance, Privacy, and Internal Audit.
• Manage and hold accountable a third-party GRC services vendor, ensuring delivery quality, prioritization, and alignment to Clover’s risk appetite.

Clover Health is reinventing health insurance by combining data with human empathy to keep members healthier. They've created custom software and analytics to empower their clinical staff to intervene and provide personalized care. Those who work at Clover are passionate and mission-driven individuals with diverse areas of expertise, working together to solve the most complicated problem in the world: healthcare.

• Lead project execution by aligning client needs with team tasks and deliverables.
• Collaborate with Regulatory Affairs partners to define system intent, launch strategies, and regulatory pathways.
• Provide real-time guidance, training, and problem-solving for engineers, particularly within the Software Test and documentation realms.

Full Spectrum partners with leading companies in MedTech to develop cutting-edge software for medical devices. With projects focused on embedded systems, mobile apps, robotics, engineers at Full Spectrum love the challenge of working with clients on products that have a meaningful impact.

• Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for over 35 trials per year.
• Serve as the internal project manager for assigned oncology disease groups, providing timely updates on submission status and regulatory guidance on study development.
• Act as the liaison between sponsors, investigators, Winship, Emory IRBs, external IRBs, and internal departments, ensuring all facets of each protocol are compliant.

Emory University is a leading research university that fosters excellence and attracts world-class talent. Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center dedicated to discovering cures for cancer and providing innovative therapies and clinical trials.

• Provide post-go-live administrative support for multiple clients
• Solutioning and configuration of Vault applications to meet customer needs
• Assistance with Quality processes including SOPs, Quality Events, CAPAs, Deviations, Change Control, Audits, and Training

Veeva Systems helps life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies, they surpassed $3B in revenue and are a public benefit corporation committed to balancing the interests of customers, employees, society, and investors.

• Execute end-to-end third-party and vendor risk assessments.
• Develop, maintain, and enhance risk metrics, dashboards, and reporting.
• Assist with additional GRC activities as needed, including policy management, risk assessments, control testing, and compliance initiatives

Aprio is a Top 20 CPA and advisory firm that accounts for anything. With over 3,200 team members and 40 U.S. office locations, plus international offices, they bring proven expertise and strategic foresight to fast-growing industries.

• Oversee the clinical data lifecycle for a portfolio of studies: ensuring timelines and data integrity are maintained.
• Identify data-related risks and implement mitigation strategies, while driving process improvements and adopting emerging technologies as needed.
• Develop and oversee the design of Case Report Forms (CRFs) and electronic data capture (EDC) systems to ensure accurate, complete, and protocol-compliant data collection.

Oura's mission is to empower every person to own their inner potential by providing insights on readiness, activity, and sleep quality through their Oura Ring and connected app. As a quickly growing company, they ensure that their team members have what they need to do their best work — both in and out of the office.

• Establishes and maintains a document management system for regulatory electronic files.
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
• Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.

• Lead life science customers in the rapid installation of clinical trial solutions like eTMF and CTMS for sponsors, CROs, and research centers.
• Manage the full implementation lifecycle, including project planning, requirements gathering, configuration, validation, training, and go-live activities.
• Serve as the primary customer liaison, managing communication, risks, and project reporting between the project team, customer, and internal stakeholders.

Veeva Systems is a mission-driven pioneer in industry cloud software, helping life sciences companies bring therapies to patients faster. As a fast-growing SaaS company with over $3B in revenue, it is a public benefit corporation (PBC) with values focused on customer and employee success, operating as a 'Work Anywhere' company with a global team.

• Own security posture, compliance programs, and audit readiness.
• Lead all IT functions supporting corporate and program needs.
• Provide guidance and escalation support for IT hardware/software issues as needed.

Red Cell Partners is an incubation firm building and investing in rapidly scalable technology-led companies. They bring revolutionary advancements to market in healthcare, cyber, and national security and are united by a shared sense of duty.

• Help to keep up to date and implement new features within the Veeva Regulatory suite.
• Act as customer liaison, managing communication between implementation and maintenance teams, customer stakeholders, and internal Veeva Product teams.
• Drive change management methodology for our customers switching from on-premises to SaaS solutions.

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed.