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
Lead and deliver risk-based GCP/GCLP audits across internal and external partners.
Own audit planning, execution, reporting, and CAPA oversight as a subject matter expert.
Coach peer auditors and collaborate globally within the Global Quality Audit team.
Ipsen is a global mid-sized biopharmaceutical group specializing in transformative medicines in oncology, rare diseases, and neurosciences. With nearly 100 years of experience and hubs in the US, France, and UK, the company has passionate teams in over 40 countries and brings medicines to patients in 88 countries.
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.
Provide strategic quality oversight for global clinical operations, including decentralized clinical trials and patient-focused healthcare services.
Ensure compliance with global regulations, sponsor expectations, and established quality systems through risk management and continuous improvement.
Lead investigations, audits, and CAPA activities to support safe, efficient, and reliable clinical trial delivery.
The partner company is a mission-driven organization focused on improving access to healthcare solutions. They foster a supportive, inclusive, and collaborative work environment with a remote-first culture.
Oversee GCP quality systems and provide QA leadership for global clinical operations including decentralized trials.
Lead investigations, CAPAs, risk assessments, and audits to ensure regulatory compliance.
Review clinical documentation, support vendor qualification, and mentor QA staff.
WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trial services, home health, and market access solutions. With over 15 years of global experience across 150+ countries, the company fosters a collaborative and mission-driven culture.
Manage and oversee the GCP Quality Management System for global clinical operations, including decentralized trials.
Lead quality investigations, CAPAs, and audits to ensure compliance with regulatory standards.
Provide strategic quality advice and drive continuous improvement across the organization.
WEP Clinical partners with biopharmaceutical sponsors to bring treatments to patients through clinical trial delivery and home health services. With over 15 years of global experience, the company fosters a collaborative, innovative culture focused on improving patient outcomes.
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.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
Independently reviews sales transactions and customer files to ensure compliance with quality, regulatory, and risk standards.
Provides evidence-based feedback and coaching to frontline teams to improve performance and understanding of quality expectations.
Collaborates with operational leaders, risk partners, and compliance teams to strengthen quality awareness and risk management practices.
Our partner is a company looking to strengthen operational excellence by reviewing sales transactions and customer files for compliance with quality, regulatory, and risk standards. The organization fosters a culture of accountability, transparency, and continuous improvement, offering a supportive environment focused on professional growth and collaboration.
Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.
Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.
Conduct clinical audits, risk assessments, and process reviews to identify compliance gaps and improvement opportunities.
Manage multiple client engagements and collaborate with healthcare client teams to ensure successful project execution.
Prepare and present audit results and recommendations to clinical, operational, and executive leadership.
Kodiak Solutions provides technology-driven solutions for healthcare finance, risk management, and revenue cycle management. The company's size and culture are not disclosed in the posting.
Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.