Lead end-to-end GCP auditing processes, including scheduling, conducting, reporting, and follow-up for sites, vendors, and internal processes globally
Apply deep knowledge of FDA, EU, and ICH regulations to independently resolve compliance issues and represent GDQA on cross-functional teams
Develop risk-based audit strategies, mentor new staff, and support regulatory inspections with 6+ years of experience including 4+ years direct GCP auditing
Regeneron is a leading biotechnology company that invents life-changing medicines for people with serious diseases. Founded and led by physician-scientists for over 30 years, we have developed nine FDA-approved treatments and numerous candidates, fostering a culture of innovation recognized as a Great Place to Work.
Lead internal audits, gap assessments, and action item closure for periodic QMS reviews
Manage and maintain design and development files for FDA regulated products
Build and refine quality systems and SOPs in line with cGxP, ISO 13485, and other applicable standards
UpDoc builds the first clinically validated, physician-supervised AI agents that manage chronic diseases. Founded by Stanford physicians, it is an early-stage startup focused on bringing its AI-powered platform to patients and providers.
Lead and develop a world-class Service & Repair Quality organization across multiple international sites, driving continuous improvement and regulatory compliance.
Apply global regulatory requirements to Service & Repair processes, including FDA, GMP, CAPA, ISO 13485, and lead quality support during regulatory inspections.
Develop statistically sound sampling plans, use data analysis to identify trends, and build strong partnerships with site leadership and stakeholders.
This is a senior quality leadership opportunity within a global medical technology environment focused on delivering safe, reliable, and innovative healthcare solutions. The company is a partner of Jobgether, with operations across the US, Germany, and Japan, and emphasizes a collaborative, ethical, and inclusive culture.
Leads quality compliance, risk management, and vendor oversight programs to support late-stage development.
Manages inspection readiness, data integrity assessments, and regulatory authority interactions across GxP.
Provides senior-level quality judgment and drives risk-based decisions in a dynamic environment.
Braveheart Bio is a clinical-stage biopharmaceutical company developing therapies for hypertrophic cardiomyopathy and other cardiovascular diseases. It has a proven leadership team, strong financial foundation, and a high-value late-stage asset, offering an opportunity for mission-driven professionals.
Provide quality oversight and direction to vendors to ensure cGMP compliance for clinical manufacturing.
Lead clinical lot disposition, batch record review, and QP certification for global trials.
Oversee GMP quality systems including deviations, investigations, and audits at contract manufacturing partners.
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. It is a small, lean organization within the Roivant family, focusing on collaboration and innovation.
Lead and manage the external audit process, coordinating with auditors and internal teams to ensure timely and accurate financial statement audits.
Oversee financial reporting compliance with U.S. GAAP and statutory requirements, including audits for domestic and international entities.
Identify process improvements and mentor team members to enhance audit readiness and reporting efficiency.
Geosyntec is an international engineering and consulting firm specializing in environmental, natural resources, and civil infrastructure projects. It is ranked among the top environmental engineering design firms by ENR and offers a collaborative culture with competitive benefits.
Lead global pharmacovigilance audits, regulatory inspections, and readiness planning.
Oversee issue management, deviations, root-cause analysis, and CAPA activities.
Develop and manage the global pharmacovigilance training program and procedural documentation.
Our partner is a fast-growing biopharmaceutical company focused on improving outcomes for patients with severe autoimmune diseases. It offers a collaborative environment with opportunities for professional growth and leadership development.
Manage and execute the risk-based audit plan in alignment with annual audit objectives.
Supervise and develop audit team members through coaching and performance management.
Oversee planning, execution, and reporting of assurance and advisory engagements.
Progressive Leasing is a leading provider of in-store and e-commerce lease-to-own solutions. It is a subsidiary of PROG Holdings, a FinTech holding company, and fosters a culture of inclusion, collaboration, and innovation.
Manage and oversee the GCP Quality Management System for global clinical operations, including decentralized trials.
Lead quality investigations, CAPAs, and audits to ensure compliance with regulatory standards.
Provide strategic quality advice and drive continuous improvement across the organization.
WEP Clinical partners with biopharmaceutical sponsors to bring treatments to patients through clinical trial delivery and home health services. With over 15 years of global experience, the company fosters a collaborative, innovative culture focused on improving patient outcomes.
Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, packaging, and labeling.
Lead resolution of deviations, OOS/OOT, change controls, CAPAs, and product quality complaints with risk-based decisions.
Represent Product Quality on CMC and external partner teams to support development, regulatory submissions, and commercialization.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company values trust, ownership, curiosity, and results, fostering a culture of diversity and inclusion with a small but dedicated team.
Provide strategic regulatory leadership for companion diagnostics (CDx) and precision medicine programs across global markets.
Lead consulting engagements, guiding clients through FDA, EU IVDR, and international regulatory pathways from development to commercialization.
Mentor consulting team members and contribute to a collaborative regulatory practice focused on precision medicine innovation.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It operates remotely with a focus on efficiency and data privacy.
Provide strategic quality leadership for CMC activities across cell therapy programs.
Lead product quality strategy and lifecycle management with risk-based control strategies.
Oversee QC operations and external partner quality oversight.
BrainChild Bio is a clinical-stage biotechnology company developing CAR T cell therapies for central nervous system tumors. The company prioritizes pediatric brain tumors with a pipeline extending to adult indications, and every team member directly impacts bringing therapies to patients.