GCP Quality Auditor Job at Amgen (Uxbridge)

Director of Quality Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...

Location

United States , Berkeley

Salary:

220000.00 - 235000.00 USD / Year

Caribou Biosciences

Expiration Date

Until further notice

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

Fulltime

Gvp compliance lead

BioMarin is looking for an individual with experience working in Pharmacovigilan...

Location

United States

Salary:

176000.00 - 242000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations
Experience working in Pharmacovigilance (PV) within Quality and Compliance
Experience executing or managing Health Authority Inspections
Experience executing or managing R&D Audits and GVP Audit Program
Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
Experience navigating and understanding a quality management system
Core leadership competencies in strategic thinking, agility, prioritization, communication and decision making
Experience in managing staff and leading teams
Strong verbal, written and oral communication skills. Able to present to Senior Leadership.

Job Responsibility

Championing the implementation of Global Quality vision, policies, processes, and decisions
Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
Continually enhance partnerships with key stakeholders and leaders across the business
Support and drive the implementation of quality and compliance projects and objectives
Stay updated on regulations and recommend proactive compliance changes when necessary
Develop and enhance GVP Compliance processes and best practices
Lead the execution of the GVP Compliance Global Audit Program
Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GVP Compliance Audit Program
Contribute to Pharmacovigilance System Master File (PSMF) updates

What we offer

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

Fulltime

Director, GVP Compliance

BioMarin is looking for a GVP Compliance Lead to advise internal and external ke...

Location

United Kingdom , London

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations
Experience working in Pharmacovigilance (PV) within Quality and Compliance
Experience executing or managing Health Authority Inspections
Experience executing or managing R&D Audits and GVP Audit Program
Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
Experience navigating and understanding a quality management system
Core leadership competencies in strategic thinking, agility, prioritization, communication and decision making
Experience in managing staff and leading teams
Strong verbal, written and oral communication skills. Able to present to Senior Leadership.

Job Responsibility

Championing the implementation of Global Quality vision, policies, processes, and decisions
Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
Continually enhance partnerships with key stakeholders and leaders across the business
Support and drive the implementation of quality and compliance projects and objectives
Stay updated on regulations and recommend proactive compliance changes when necessary
Develop and enhance GVP Compliance processes and best practices
Lead the execution of the GVP Compliance Global Audit Program
Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GVP Compliance Audit Program
Contribute to Pharmacovigilance System Master File (PSMF) updates

Fulltime

Process Quality Excellence Specialist

This is a hands-on, coordination-focused quality role, suited to someone comfort...

Location

United Kingdom , Berkshire

Salary:

47.92 GBP / Hour

CK Group

Expiration Date

Until further notice

Requirements

Experience in Regulatory Intelligence, RIN coordination, or regulatory compliance within a GxP environment
Prior involvement in quality audits, either as an audit host or audit support function
Strong understanding of GCP and clinical research regulatory requirements
Excellent organisational, coordination, and communication skills
Ability to work across multiple stakeholders and manage timelines effectively
QA background welcomed but not essential

Job Responsibility

Act as the RIN Coordinator for GCSO, managing Regulatory Intelligence Notifications and associated actions
Review new and updated regulations and guidance, assessing impact on controlled documents
Identify and assign appropriate Subject Matter Experts (SMEs) based on regulatory topics
Track actions and timelines, ensuring follow-up and completion
Act as a point of contact to confirm CRO assessment of regulatory and country-specific requirements impacting SOPs and clinical studies
Act as Audit Host for internal quality audits
Coordinate with the internal Auditing team and relevant SMEs and functions
Prepare for audits, manage documentation requests, and track timelines
Support SMEs during audits by coordinating responses to auditor queries
Manage post-audit activities including findings, CAPAs, and follow-up actions through to audit closure

Fulltime

Senior IT Auditor

We are seeking an experienced Senior IT Auditor with active CISSP and CISA certi...

Location

United States , Boca Raton

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Information Systems, Computer Science, Accounting, or related field
Active CISSP and CISA certifications (both required)
5–8+ years of IT audit experience (Big 4 or large corporate internal audit preferred)
Hands-on experience auditing: Cloud platforms (AWS, Azure, GCP)
ERP systems (SAP S/4HANA, Oracle EBS/Fusion)
Cybersecurity frameworks (NIST CSF, CIS Controls, ISO 27001)
ITGCs, automated controls, and segregation of duties (SoD)
Expertise in SOX 404 compliance and PCAOB audit standards
Advanced knowledge of COBIT, ITIL, NIST 800-53, and CIS benchmarks
Proficient in audit tools: TeamMate+, AuditBoard, Diligent, Workiva, or Alessa

Job Responsibility

Lead end-to-end IT audits including planning, scoping, fieldwork, testing (design & operating effectiveness), and reporting for SOX 404, SOC 2, ISO 27001, NIST, and internal risk-based audits
Evaluate ITGCs across ERP systems (SAP, Oracle, NetSuite), cloud environments (AWS, Azure, GCP), Active Directory, databases, and network infrastructure
Perform integrated audits combining financial, operational, and IT controls with cross-functional audit teams
Assess cybersecurity controls (identity/access management, encryption, vulnerability management, incident response, zero trust architecture)
Conduct third-party risk assessments and review vendor SOC reports, contracts, and SLA compliance
Identify control gaps, quantify risk, and draft actionable, prioritized recommendations
Present audit findings and remediation plans to C-suite, Audit Committee, and Board-level stakeholders
Mentor junior auditors and co-source resources
review workpapers for quality and completeness
Stay ahead of emerging risks: AI/ML governance, quantum computing threats, ransomware frameworks, and GenAI security

What we offer

medical, vision, dental, and life and disability insurance
eligible to enroll in our company 401(k) plan
free online training

Supervisor, Quality Operations

Determines and maintains quality standards developed in compliance with current ...

Location

United States , Rockford

Salary:

66000.00 - 69000.00 USD / Year

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor's Degree in a related field and/or 1-5 years related experience and/or training
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms
High Standard of Report Writing

Job Responsibility

Coordinates the daily activities of the QA Auditors
Assists with the daily activities of Production Inspection personnel for packaging
Implements inspection criteria and testing
Study and standardize departmental work practices to improve the quality and efficiencies of subordinates
Helps resolve quality-related issues with other departments and customers. Motivates, develops and provides continuous training either through the use of departmental work instructions, examination of cGMP's and SOP's, specific customer requirements or by personal instruction
Review records for accuracy of information, compliance with established procedures
Reviews daily paperwork to assure all customer requirements and quality standards have been met and maintained
Promotes continuity of shifts through cooperation and communication within as well as with other departments
Assist in the performance of monthly internal audits and any necessary corrective action to follow-up
Oversees Pest Control and Environmental (humidity, temperature, MKT). Monitoring Programs May disposition NMR's

What we offer

paid time off
health insurance coverage (including dental and vision)
a flexible spending account
401(k)
annual 5% performance bonus eligibility

Fulltime

Audit Automation Engineer

The Internal Audit team is transforming its assurance capabilities to focus on c...

Location

Romania , Bucharest

Salary:

Not provided

Braze

Expiration Date

Until further notice

Requirements

3–5 years of experience building automation or data solutions in production (software engineering, data engineering, or internal tools)
Demonstrated experience in full-stack development using Angular, TypeScript, and Python
Demonstrated experience deploying LLM-backed features and building/maintaining AI workflows
Demonstrated experience with Git and GitHub for version control and implementing CI/CD pipelines
Demonstrated experience maintaining and troubleshooting Workiva Chains and Wdata continuous monitoring pipelines
Strong Python and SQL skills (performance-aware queries, modular code, unit tests)
Experience integrating REST/Graph APIs and working with JSON payloads at scale
Strong written and verbal English language skills are essential

Job Responsibility

Design, build, and maintain full-stack web applications that deliver continuous auditing capabilities to internal stakeholders
Develop, deploy, and maintain AI-enabled workflows and agents for evidence collection and anomaly surfacing, utilizing tools like Google AI Studio
Write, test, and maintain robust scripts (Python, SQL) for data extraction, manipulation, automated control testing, and data quality validation across source systems
Maintain and optimize existing continuous monitoring infrastructure built using Workiva Chains and Wdata for financial and operational controls
Write clean, scalable code across the entire stack, primarily using TypeScript for the front end and Python for the back end
Manage the deployment lifecycle for all automations, ensuring code integrity, establishing observability, and owning the CI/CD process via GitHub
Develop APIs and connectors to source systems (e.g., ERP, HRIS) and design code-based control tests (Python, SQL)
Partner with auditors as a Technical SME to interpret control objectives and ensure automation accuracy
Produce concise engineering documentation (readme/runbooks), not traditional audit workpapers

What we offer

Competitive compensation that may include equity
Retirement and Employee Stock Purchase Plans
Flexible paid time off
Comprehensive benefit plans covering medical, dental, vision, life, and disability
Family services that include fertility benefits and equal paid parental leave
Professional development supported by formal career pathing, learning platforms, and a yearly learning stipend
A curated in-office employee experience, designed to foster community, team connections, and innovation
Opportunities to give back to your community, including an annual company-wide Volunteer Week and donation matching
Employee Resource Groups that provide supportive communities within Braze

Fulltime

New

SOX Compliance & Access Governance Specialist

We are seeking a detail-oriented professional to support SOX compliance and acce...

Location

India , Pune

Salary:

Not provided

Vodafone

Expiration Date

Until further notice

Requirements

Approximately 5 years of experience in SOX compliance, IT controls, internal audit, or risk management
Working knowledge of SOX concepts, particularly IT General Controls
Familiarity with User Access Management processes including Joiner, Leaver and Periodic Reviews
Basic understanding of IT environments, applications, and access controls
Exposure to internal or external audits, including evidence preparation and auditor interactions
Awareness of information security standards such as ISO 27001 is an advantage
Strong analytical skills, attention to detail, and accuracy
Bachelor’s degree in Finance, Accounting, Information Systems, Engineering, or a related field
Professional certifications (SOX, CISA, ISO 27001) are advantageous though not mandatory
Awareness of cloud platforms (AWS, Azure, GCP) is desirable

Job Responsibility

Execute and monitor assigned SOX controls across the VCI environment in accordance with defined control requirements
Support ongoing compliance monitoring aligned with internal policies, standards, and regulatory obligations
Assist in performing SOX control activities including preparation, review, and maintenance of audit documentation and evidence
Contribute to User Access Management (UAM) tasks, including Joiner, Leaver, and Periodic Access Review cycles
Prepare and maintain high-quality documentation aligned with SOX, access governance, and security standards
Collaborate with internal teams and stakeholders to support internal and external audit activities and respond to audit queries
Support UAM enablement activities for new or onboarding SOX-relevant services and applications
Track remediation activities and support closure of identified SOX control deficiencies

What we offer

Exposure to global audit processes
Opportunities to collaborate across multi-functional teams
Meaningful development in SOX, governance, and access management
Experience in cloud environments, regulatory frameworks, and security standards
Enhancing professional credibility and long-term career progression

GCP Quality Auditor

Amgen

Location:
United Kingdom , Uxbridge ▼
London
Edinburgh
Cambridge
Aberdeen

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 18, 2025

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