gxp audit response manager

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target...

Intuitive is seeking a QA Manager, Audits & Inspections to lead GxP audit programs and maintain FDA/regulatory inspection readiness through Phase 3 and beyond. The role partners with Clinical Operations and Regulatory teams to identify risks, manage observations, and drive CAPAs with strong cross-functional collaboration.The candidate will oversee internal,...

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target...

Intuitive Surgical, Inc. in Sunnyvale, CA is seeking a Quality Assurance Manager, Audits & Inspections to lead GxP audit programs and prepare for FDA inspections throughout late-stage development.You will partner with Clinical Operations, Regulatory Affairs and other teams to identify risks, manage findings and CAPAs, and ensure readiness for regulatory...

Daiichi Sankyo in the United States seeks a senior leader to head Global GxP Audits. You will report to the Head, Global GxP Audits, coordinating with teams in Europe, Asia and Latin America.You will oversee end-to-end GxP audits, CAPA management, and inspection readiness to maintain regulatory compliance across the organization. The role emphasizes...

Intuitive Surgical is a global leader in robotic‑assisted surgery. The Quality Assurance Manager, Audits & Inspections, will lead GxP audit activities and oversee regulatory inspection readiness for FDA reviews, collaborating with Clinical Operations, Regulatory Affairs, and pharmacovigilance to mitigate risks and ensure compliant operations. This...

Thermo Fisher Scientific in Richmond, VA is seeking a Quality Assurance Auditor III to join our BIOA Laboratory onsite. You will lead diverse client, internal, and GxP audits, ensure compliance with global regulatory standards, and prepare audit reports for management and clients. Requires a Bachelor's degree or equivalent and 5+ years QA experience, strong...

Title: GxP Quality & Compliance Manager Job Description: NOW HIRING: GxP Quality & Compliance Manager CA & AZ Compensation: $110,000-$120,000 per year Travel up to 50% required Job Overview SBM is seeking a hands‑on GxP Quality & Compliance Manager to support the execution, compliance, and continuous improvement of Critical Environments services across...

CBRE seeks a senior leader to guide the Quality Representatives staff on major client accounts or CBRE's corporate QA teams. You will ensure delivery of all quality and compliance deliverables under MSA, QA, and SLA agreements, coordinating with client leadership and internal teams.Applicants should bring 8–10 years in pharma QA, GxP expertise, and a track...

Hiring: Program Manager – GxP CAPA Remediation Location: Greenville, NC Work Arrangement: Onsite We are looking for an experienced Program Manager – GxP CAPA Remediation to lead and coordinate complex CAPA and quality remediation initiatives within a pharmaceutical / life sciences manufacturing environment.Key Responsibilities:Lead and coordinate CAPA...

Theradex Oncology is seeking a Manager, Validation & Testing to lead CSV, QA, and testing for GxP and non-GxP systems. The role focuses about 50% on building automated testing frameworks and scaling them across the portfolio.You will collaborate with stakeholders, developers, and regulatory personnel to ensure compliant, high-quality system validation and...

GxP Critical Environments ManagerNOW HIRING: GxP Critical Environments ManagerCompensation: $90,000-$100,000 per yearJob OverviewThe Critical Environments Manager will be responsible for coordination and directing operations necessary to carry out contractual responsibilities between SBM and customers. This includes all necessary planning, supervision,...

Daiichi Sankyo, Inc. in New Jersey seeks an Senior GxP Audit Leader who will oversee the end-to-end GxP audit program across the US and collaborate with teams in Europe, Asia, and Latin America to ensure regulatory compliance.You will drive CAPA development and effectiveness, manage CAPA metrics, and support FDA/EU inspections, with a focus on continuous...

Role: Program Manager - GxP CAPA Remediation Location: Greenville, SC (Hybrid)Duration: 12+ Months Mandatory areas:Program Manager: 10+ yearsMust Have skills:GXP, CAPA, FDA Audit, Lean – Six Sigma About the role: Seeking an experienced Program Manager to lead CAPA remediation workstreams in a regulated pharmaceutical manufacturing environment. This role...

Sodexo is seeking a GXP Technician to support a Life Science client in Rahway, NJ. This role supports laboratory operations through GXP sanitization, waste management, material delivery, and adherence to established procedures. Key responsibilities include coordinating laboratory waste collection and removal, ensuring proper waste labeling and packaging,...

Care Access seeks a Digital Quality & GxP Manager to join our Quality team and guide GxP quality across software products, AI components, and systems. You will lead compliance activities, align with regulatory expectations, and collaborate with multiple stakeholders in a fast-paced tech environment. The role emphasizes hands-on GxP implementation, audits,...

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.The Manager of GxP Training, Quality Systems supports the administration,...

About the Role Our IT Services practice provides managed IT, cybersecurity, and regulated-industry compliance services to life sciences and biotech companies, from seed stage through public companies. We help clients implement technology, operate it reliably, and demonstrate that the controls supporting regulated work are effective. The Opportunity We are...

Technical Project Manager - SaMD / GxP Validation.We need an independent, Quality-first project manager to drive an imaging algorithm Software as a Medical Device (SaMD) program in R&D IT toward a trial launch targeted for Q3. You will run the plan, clear blockers and own the validation documentation, all within a regulated Quality Management System (QMS)....

Daiichi Sankyo in the United States seeks a senior leader to head Global GxP Audits. You will report to the Head, Global GxP Audits, coordinating with teams in Europe, Asia and Latin America. You will oversee end-to-end GxP audits, CAPA management, and inspection readiness to maintain regulatory compliance across the organization. The role emphasizes...