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.
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.
Drive collaboration with Operations to achieve target FTPR levels and contribute to critical metrics.
Improve safety in the QC Laboratory through established protocols and compliance.
Lead root cause analysis for quality incidents and manage corrective actions.
Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly against the role's core requirements. Their system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
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.
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.
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.
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.
Conduct remote stakeholder interviews and requirements elicitation sessions
Analyze and document business processes, workflows, and system requirements
Develop business cases and propose process improvement solutions
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.
Own the global clinical supply strategy for late-stage programs.
Manage external partners, including packaging and labeling vendors.
Serve as the clinical supply chain lead on cross-functional study teams.
Jade Biosciences is focused on developing innovative therapies to address critical unmet needs in autoimmune diseases. They are developing JADE101 for the treatment of immunoglobulin A nephropathy (IgAN).