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.
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.
Manage supplier quality events, including nonconformances, root-cause analyses, CAPAs, and corrective actions.
Support supplier qualification, onboarding, audits, and performance monitoring through scorecards and metrics.
Collaborate cross-functionally with supply chain, regulatory, and operations teams to ensure GMP compliance.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It uses technology to review applications and share top-fitting shortlists with employers, focusing on objective and fair hiring.
Lead and develop a world-class Service & Repair Quality organization across multiple international sites, driving continuous improvement and regulatory compliance.
Apply global regulatory requirements to Service & Repair processes, including FDA, GMP, CAPA, ISO 13485, and lead quality support during regulatory inspections.
Develop statistically sound sampling plans, use data analysis to identify trends, and build strong partnerships with site leadership and stakeholders.
This is a senior quality leadership opportunity within a global medical technology environment focused on delivering safe, reliable, and innovative healthcare solutions. The company is a partner of Jobgether, with operations across the US, Germany, and Japan, and emphasizes a collaborative, ethical, and inclusive culture.
Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, packaging, and labeling.
Lead resolution of deviations, OOS/OOT, change controls, CAPAs, and product quality complaints with risk-based decisions.
Represent Product Quality on CMC and external partner teams to support development, regulatory submissions, and commercialization.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company values trust, ownership, curiosity, and results, fostering a culture of diversity and inclusion with a small but dedicated team.
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.
Manage analytical development, QC, and stability activities at contract manufacturing sites.
Author and review CMC sections for US and ex-US regulatory filings.
Collaborate with Quality Assurance to close investigations and manage change controls.
BridgeBio is a biotech company that pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and develop medicines for rare diseases. They foster a culture of curiosity and experimentation with small teams of experts.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
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.
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.