Assure quality standards and compliance within mission-critical solutions.
Integrate customer requirements and international quality standards.
Manage quality assurance and contribute to ensuring safety and security.
Jobgether is a platform that connects job seekers with companies. They leverage AI-powered matching to ensure fair and objective application reviews, aiming to streamline the hiring process for both candidates and employers.
Serve as QA owner for clinical-stage combination product complaints.
Ensure timely assessment of complaints for potential impact to patient safety.
Partner with Regulatory Affairs and Pharmacovigilance to support complaint-related regulatory submissions.
Akero Therapeutics, a Novo Nordisk company, is dedicated to discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. They foster a collaborative environment where diverse skill sets and backgrounds are valued, encouraging employees to bring their best thinking to work.
Conduct inspections and audits of contract performance
Zantech is a dynamic Woman Owned Small Business focused on providing complex, mission-focused solutions. They have a proven track record of outstanding customer performance and high employee satisfaction and embraces the opportunity to hire individuals with new talents and fresh perspectives.
Lead GxP system qualification and validation activities for the eQMS, COTS, and TPS using a risk-based approach.
Administer and continuously improve eQMS quality event workflows - CAPA, nonconformance records (NCR), deviations, change controls, and document management.
Lead and maintain the Vendor Qualification Program and Third-Party System (TPS) audit schedule, including initial qualification, periodic requalification, performance monitoring.
Cogstate is advancing the science of brain health - making it faster, easier, and more accurate to assess cognition across clinical trials, healthcare settings, and everyday life. Our global team of experts spans psychology, data science, operations, and technology.
Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer, developing, manufacturing, and supplying high-quality generic and branded injectables. They have locations in New York, Ohio, and California and sales territories nationwide and have been in business for over 50 years.
Oversight of all project related quality activities
Drive project related quality improvement and providing quality advice
Client management including direct oversight for client quality related activities for project
PrimeVigilance, part of Ergomed Group, is a mid-sized pharmacovigilance service provider established in 2008. They offer services in medical information, pharmacovigilance, regulatory affairs, and quality assurance, with staff across Europe, North America, and Asia. They maintain long lasting relationships and becoming one of the global leaders in its fields.
Investigate product complaints and evaluate potential adverse events.
Analyze field complaints and support product investigations.
Ensure complaint handling complies with FDA and ISO regulations.
Fusion Life Sciences Technologies is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. Their wide network of consultants and contract-to-hire engineers brings deep expertise across various sectors, leveraging AI-powered software for sourcing and screening top talent with rapid response times.
Review analytical data for release, stability, and in-process testing.
Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results.
Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages.
BridgeBio pioneers a “moneyball for biotech” approach. They pool projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation and build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines.