Ensure the quality and compliance of clinical trials.
Interpret regulatory requirements.
Lead the development and implementation of quality assurance strategies.
Jobgether is a company, posting this job on behalf of a partner company. They use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements.
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.
Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
Develop and implement inspection readiness plans and procedures for Health Authority inspections.
Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.
Develop submission strategies and plans for post-approval CMC activities.
Assess change controls and provide regulatory assessments of quality changes.
Coordinate submission preparation with various departments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.
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.
Lead quality assurance activities, ensuring high standards are maintained across clinical projects.
Guide teams in compliance with industry regulations and best practices while fostering a culture of continuous improvement.
Mentor QA staff and drive the quality objectives within a dynamic and growing organization.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. The system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
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.
Oversee end-to-end ICSR collection, processing, reconciliation, and reporting of post-marketing cases.
Ensure global compliance with pharmacovigilance regulations, including timely ICSR submission, high-quality case processing, and support for aggregate reporting.
Provide oversight and support of the PV vendor activities, including but not limited to the establishment and monitoring key performance indicators (KPIs) and vendor audits.
Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. They were founded to develop a better way to treat the cellular drivers of tumor growth and committed to fair and equitable compensation practices.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.
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.
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.