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 quality oversight of sterile drug product and finished drug product manufacturing, labeling, packaging, and distribution operations.
Review and approve batch production records, process validation documents, and quality system records such as deviations and change controls.
Support regulatory agency inspections and author NDA CMC sections to ensure compliance with GMP and GDP standards.
Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs, such as post-bariatric hypoglycemia, Wolfram syndrome, and ALS. The company has an experienced team driven by core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of caring.
Lead the execution and continuous improvement of quality management systems to ensure compliance with FDA, ICH, GCP, and ISO 9001 standards.
Manage electronic Quality Management System (eQMS) including document control, CAPA, risk management, and audit processes.
Provide quality oversight for clinical trial activities and software development lifecycle, collaborating with cross-functional teams.
The partner company is a fast-growing healthcare and life sciences organization focused on improving clinical research. It values collaboration, curiosity, and continuous improvement, and supports teams through scalable systems and risk management.
Lead the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets.
Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations.
Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.
Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.
Lead global pharmacovigilance operations for clinical trials and post-marketing safety.
Ensure regulatory compliance with FDA, ICH, and GVP standards across international markets.
Build and mentor high-performing teams while driving business development and financial performance.
The company is a fast-growing clinical research organization specializing in pharmacovigilance and drug safety. It emphasizes operational excellence, regulatory compliance, and patient safety, with a global reach and a collaborative culture.
Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.
Conduct remote audits of medical device quality management systems against ISO 13485 and EU MDR.
Review objective evidence, identify findings, and deliver structured audit reports.
Apply sound regulatory judgement and support continuous improvement of audit processes.
The partner company specializes in assessing innovative health technologies and ensuring regulatory compliance for medical devices. It operates with a quality-focused culture, valuing autonomy and regulatory expertise.
Provide strategic leadership and oversight for all clinical data management activities across the development program.
Partner with cross-functional leaders to ensure data integrity and support timely, high-quality decision making.
Oversee vendor management, data governance, and delivery of inspection-ready clinical data.
Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases like MASH. They are a team of problem solvers with a collaborative culture, dedicated to bringing out the best in each other.
Process individual case safety reports (ICSRs) for clinical trials and post-marketing programs.
Ensure accurate data entry, coding, and query resolution in the Argus Safety Database.
Collaborate with cross-functional teams to meet regulatory reporting requirements and maintain compliance.
Precision Medicine Group is a global life sciences company specializing in precision medicine and drug development services. They employ thousands of professionals and emphasize a collaborative culture.