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.
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.
Execute Computer System Validation activities for Electronic Batch Record (EBR) systems supporting aseptic fill operations.
Support development and review of validation deliverables including URS, FDS, risk assessments, and validation plans.
Collaborate with Operations, Quality, Engineering, IT, and Automation teams to define system requirements, intended use, and validation scope.
Verista teams up with the world’s most recognizable brands in the life science industry to solve their business needs. They are a fast-paced organization with a people-focused culture.
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.
Plan, execute, and maintain software validation activities.
Author and maintain validation documentation.
Collaborate with Engineering and Product to identify risks early.
Uncountable builds software that helps R&D teams manage data, workflows, and experimentation at scale. Their platform is used by scientific and engineering teams across regulated and non-regulated industries; quality, reliability, and compliance are core to how they build and ship product.
Improve our Quality Management System and related processes.
Work cross-functionally with internal and external customer teams to improve customer experience.
Effectively manage a proactive system following AS9145/ IATF 16949 requirements.
Xometry connects people with manufacturers to bring big ideas to life. As a fast-growing digital technology company, Xometry is disrupting the manufacturing industry.
Partner with GXP business leaders and translate objectives into comprehensive IT roadmaps.
Oversee selection, implementation, and validation of critical GXP systems.
Drive IT readiness for commercial launch including system scalability and disaster recovery.
Nuvalent is dedicated to creating selective medicines with the goal of addressing the needs of patients with cancer, leveraging deep expertise in chemistry. They are an early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
Set submission strategy and operational timelines.
Build, evolve, and manage the Regulatory Operations infrastructure.
Establish and oversee training on RA procedures and submission standards.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.
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.
Provides validation and UAT support for Clinical Data Management activities across studies.
Leads and coordinates functions for multiple assigned projects related to the planning, execution, collection, and cleaning of clinical data.
Works within the company’s SOPs, guidelines and standards to ensure data integrity at all times.
Iovance Biotherapeutics is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, their employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
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.
Lead the development and implementation of regulatory and quality assurance strategies.
Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team.
Act as an internal SME (Subject Matter Expert) on regulatory requirements.
Ada envisions a world where everyone gets the healthcare they need, using AI and a team of physicians and clinical scientists to help people get answers faster. If you’re passionate about transforming healthcare and ensuring no one goes undiagnosed, join Ada.
Lead SOC 2 and ISO programs through the full audit lifecycle.
Build integrations that continuously gather compliance evidence from AWS, GitHub, identity providers, and internal systems.
Evaluate and monitor third-party vendors for security and compliance risk.
Fieldguide is establishing a new state of trust for global commerce and capital markets through automating and streamlining the work of assurance and audit practitioners. The company is based in San Francisco, CA, and built as a remote-first company with a team that is inclusive, driven, humble and supportive.
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.