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...

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...

Arrowhead Pharmaceuticals, Inc. in Pasadena, CA is seeking a Supplier Quality professional to manage supplier intake and qualification within the GxP framework.You will review qualification records, risk assessments, and audit reports in Veeva QMS, and help ensure supplier readiness for regulatory inspections. Collaboration with Quality, Supply Chain, and...

Alnylam Pharmaceuticals, Inc. is seeking a QA Associate, GxP Audits & Inspection Excellence, to support the audit program, maintain accurate records, and enable inspection readiness across supplier quality management and audit lifecycles. This hybrid role is based in Cambridge, MA. The candidate will assist in documentation, dashboard preparation, and...

Arrowhead Pharmaceuticals, Inc. in San Diego seeks a qualified professional to lead supplier intake and qualification within the Supplier Quality program. You will assess risk, approve qualification records, and manage audit assets in Veeva QMS, reporting to the Sr. Manager, Supplier Quality, and supporting CAPAs as needed. The role requires 5 years of...

Overview The QA Associate, GxP Audits & Inspection Excellence, supports day-to-day operations of Alnylam's audit and inspection management program. This role is responsible for maintaining accurate records, trackers, and systems that enable inspection readiness, audit transparency, and efficient quality oversight. The role uses judgment within established...

Vertex Pharmaceuticals is seeking an IT Compliance leader based in Boston to serve as the primary DTE liaison for audit, inspection, and regulatory readiness across GxP, SOX, and internal controls. You will coordinate cross-functional readiness, manage evidence, and drive remediation and CAPA closure with leadership visibility. Role requires 5-8+ years in IT...

GxP Compliance Manager# Careers## GxP Compliance ManagerApply: REMOTENJ Remote - New Jersey: Hillsboro, OR: Full time: Posted Today: JR108801# **Title:**GxP Compliance Manager# **Job Description:****Now Hiring: GxP Compliance Manager****Salary: $90,000-$100,000****Travel up to 25%****Job Overview**The GxP Compliance Manager is responsible for overseeing...

We are seeking an experienced Program Manager – GxP CAPA Remediation to lead the coordination, execution tracking, and governance of site-level Corrective and Preventive Action (CAPA) and remediation workstreams within a regulated pharmaceutical manufacturing environment.This is a domain-focused program management role, responsible for managing a complex...

OverviewCreate a future where DNA is no longer destiny. Join Rocket Pharma.Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene...

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...

Title: GxP Critical Environments Manager Job Description: NOW HIRING: GxP Critical Environments Manager Compensation: $90,000-$100,000 per year Job Overview The Critical Environments Manager will be responsible for coordination and directing operations necessary to carry out contractual responsibilities between SBM and customers. This includes all...

Company OverviewReq ID: 396922 NTT DATA strives to hire exceptional, innovative, and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a candidate to join our team in Plano, Texas (US-TX), United States (US). • GxP and Validation...

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...

Exelixis Inc. is seeking a QA Process and Systems Manager to oversee risk-based validation and lifecycle compliance of GxP computerized systems. You will partner with IT, system owners, and vendors to ensure data integrity and audit readiness, driving continuous improvement across the lifecycle. The role requires 5+ years in GxP validated applications,...

GxP Quality & Compliance Manager Job Description NOW HIRING: GxP Quality & Compliance Manager CA & AZCompensation: $110,000-$120,000 per yearTravel 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 regulated life...

Arrowhead Pharmaceuticals, Inc. is seeking a senior Supplier Quality professional to manage end-to-end supplier intake, qualification, and risk assessment in line with GxP and regulatory standards. You will review qualification records and audit reports in Veeva QMS, driving CAPAs and inspection readiness. You will partner with cross-functional teams to...

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through...

Exelixis in Alameda, CA is seeking a QA Process and Systems Manager to provide risk-based QA oversight of GxP validated applications, managing end-to-end lifecycle from validation through operation and retirement, and ensuring data integrity and inspection readiness.You will partner with IT, data owners, and external vendors, review deliverables, drive...

# GxP Systems and Support AdministratorReview the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move.Apply for this job View companyRemote from: USASalary: USD 130k–150k / yrDepartment: DevOps & InfrastructureEmployment: Full TimeExperience: Open levelPublished: 7...