Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
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.
Leads and Coordinates and ensures compliance to CAPA, HHA and NCE systems.
Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
Participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM) and is broadening its vision beyond diabetes to empower people to take control of their health. Thousands of ambitious, passionate people worldwide are willing to fight like warriors to earn the trust of our customers.
Lead the planning, execution, and management of clinical trials.
Ensure compliance with FDA, ICH-GCP, and other regulatory standards.
Supervise and mentor Clinical Research Associates (CRAs) and study coordinators.
Jobgether leverages AI to match candidates with fitting roles, ensuring quick and fair application reviews. They connect top candidates directly with hiring companies, who then manage the final decision-making process.
Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
Manages the audit and inspection hosting team.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Ensure adherence to regulations and contractual obligations.
Develop and update compliance policies and SOPs.
Conduct internal compliance audits and report findings.
Equip is a virtual, evidence-based eating disorder treatment program. They aim to ensure that everyone with an eating disorder can access effective treatment, operating in all 50 states and partnered with most major health insurance plans. Since its founding in 2019, Equip has maintained a fully virtual environment.
Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
Perform review of executed batch records and test data and perform product disposition
Lead and support quality audits of contract service providers
Jobgether is a company that connects job seekers with employers through an AI-powered matching process. They focus on ensuring applications are reviewed quickly and fairly, and they value talent development.