GCP Quality Auditor Job at Amgen (Uxbridge)

Quality Assurance Auditor - Molecular BioA

Labcorp has a Quality Assurance Auditor -Molecular BioA position at 671 South Me...

Location

United States , Greenfield

Salary:

Not provided

Labcorp

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
3 years in a regulatory environment (experience in GLC/GCP roles)
1 year experience in Molecular BioA
Knowledge of GLP/GCP auditing
Experience with Molecular department specializes in the development, validation, and execution of molecular techniques such as qPCR, RT-qPCR, and Digital PCR, supporting Cell Therapies, Gene Therapies, and Vaccines
Able to influence QA strategy
Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance
Experienced in process improvement
Demonstrated ability to apply critical thinking skills
Clear communication skills, including ability to provide clear feedback

Job Responsibility

Conduct inspections in support of GLP or GCP method validation, study-based data and reports
Interpret and apply current policies, procedures and industry guidance in day-to-day auditing
Lead internal study in lab and process/facility inspections
Evaluate and follow up on inspection responses to ensure resolution
Collaborate on quality metrics and identify trends across departments
Review and provide consultation on controlled document revisions
Deliver training related to audit performance
Collaborate with QA teams across sites and contribute to local quality initiatives
Assist in the creation or revision of QA SOPs based on findings and continuous improvement efforts
Organize and manage the workload to meet business needs

What we offer

Medical
Dental
Vision
Life
STD/LTD
401(k)
Paid Time Off (PTO) or Flexible Time Off (FTO)
Tuition Reimbursement
Employee Stock Purchase Plan

Fulltime

Glp/gcp quality compliance auditor

We are seeking an experienced member to join our Quality Assurance team. The Com...

Location

United States of America , Indianapolis

Salary:

Not provided

Labcorp

Expiration Date

Until further notice

Requirements

Bachelor's degree in a Pharmacy, Chemistry or Biology related discipline
Postgraduate degree (MSG or equivalent) in science or management related discipline, preferable
10 years’ experience may be substituted for education
8 years in regulatory environment (experience in GLP/GCP roles)
4 years Laboratory / Quality background specifically with ISO 15189/ISO 13485 standards
Strong written and verbal communication skills
Excellent organizational and project management abilities
Strong negotiation, influencing and networking skills
Demonstrative skills include risk management application experience including risk-based auditing methodologies
Experience in training and developing internal auditors

Job Responsibility

Managing the Internal Audit Program: Plan and implement the internal audit program
Schedule and oversee the approved audit program
Develop and clarify audit scopes to ensure comprehensive assessments
Approve and assign internal audits to appropriate team members
Preparedness and Oversight: Ensure appropriate stakeholder engagement throughout the audit process
Facilitate effective planning and communication with all relevant parties
Audit Hosting & Regulatory Support: Serve as the primary host for internal audits
Provide regulatory inspection support and host sponsor audits as required
Severity Finding and Audit Report Review with Management: Document audit findings and develop detailed reports with actionable recommendations
Collaborate with stakeholders to implement CAPAs and monitor their effectiveness

What we offer

Medical
Dental
Vision
Life
STD/LTD
401(k)
Paid Time Off (PTO) or Flexible Time Off (FTO)
Tuition Reimbursement
Employee Stock Purchase Plan

Fulltime

Qpi Expert – Audit Management Lead

We are looking for an experienced QPI Expert – Audit Management Lead to drive au...

Location

France

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

8+ years of experience in Quality within the pharmaceutical industry
Strong exposure to Pharmacovigilance (PV)
Qualified GVP Auditor with solid QMS expertise
Good understanding of regulatory frameworks (ICH, GCP, ISO standards)
Fluent in English
French (preferred)
Strong stakeholder management and client-facing skills

Job Responsibility

Define and implement the annual internal and vendor audit strategy
Lead internal, vendor, and client audits
manage findings and CAPAs
Act as key contact for client auditors and health authority inspections
Develop, maintain, and continuously improve the QMS (including ISO 9001 alignment)
Oversee SOPs, controlled documentation, and quality tracking systems
Drive process improvements and ensure compliance with ICH, GCP, GVP, and local regulations
Manage vendor quality oversight and risk-based audit programs
Lead and mentor a small team (1–3 members) and collaborate cross-functionally

Fulltime

Senior Director, R&D GxP Audit

The Senior Director, R&D GxP Audit will lead the global strategy, execution, and...

Location

United States

Salary:

199782.30 - 270293.70 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of experience in Quality Assurance or Strategy in a regulated industry OR Master's degree and 9 years of experience in Quality Assurance or Strategy in a regulated industry OR Bachelor's degree and 11 years of experience in Quality Assurance or Strategy in a regulated industry
at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Develop and execute a global, risk-based GxP audit strategy aligned to quality and portfolio priorities
Lead internal, external, and supplier audit programs across R&D and supporting functions
Serve as a strategic advisor to the Head of R&D Quality on compliance trends, systemic risks, and assurance strategies
Build and lead a high-performing audit organization with strong technical and leadership capability
Oversee audits of clinical trial processes, pharmacovigilance systems, laboratories, quality systems, and supporting functions
Ensure audits assess both compliance to regulations and effectiveness of quality management systems
Drive consistency in audit methodology, planning, execution, reporting, and follow-up globally
Evaluate third-party quality systems, regulatory history, data integrity controls, and operational capability
Support qualification, ongoing oversight, escalation, and remediation of critical suppliers
Use quality risk management principles and data analytics to prioritize audits based on business criticality, compliance history, inspection outcomes, and emerging risks

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Senior IT Auditor

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

Location

United States , Fort Lauderdale

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
life and disability insurance
401(k) plan

Technology Audit Manager

Roku is seeking a Technology Audit Manager to join its Finance & IT Compliance t...

Location

United States , San Jose

Salary:

187000.00 - 192000.00 USD / Year

Roku

Expiration Date

Until further notice

Requirements

6–8+ years of relevant technology audit and IT SOX compliance experience, ideally combining Big 4 public accounting and in-house internal audit/SOX roles at a fast-paced public technology company
Bachelor's degree in computer science, Information Systems, Finance, Accounting, or related field
Professional certifications such as CISA, CISSP, or CISM preferred
additional certifications (CPA, CIA, CFE) are a plus
Strong experience across technology audit domains, including IT general controls (ITGCs), automated controls (ITACs), cloud infrastructure, data engineering, DevOps processes, cybersecurity, system implementations, and business process automation
Hands-on experience designing and evaluating IT general and security controls in cloud environments (AWS, GCP)
cloud certifications are highly desirable
Experience auditing or supporting enterprise platforms (e.g., NetSuite, Salesforce, Workday) and modern engineering environments (e.g., GitHub, CI/CD pipelines)
Solid understanding of SOX and broader compliance frameworks (SOC 1/2, GDPR, PCI-DSS) and security/governance standards (ISO 27001, COBIT, NIST)
Experience operating in high-growth, fast-paced environments, with the ability to scale processes and controls alongside business expansion

Job Responsibility

Lead and oversee the company’s technology SOX compliance program, evaluating the design and operating effectiveness of IT general controls, automated controls, and key reports supporting financial reporting
Maintain a deep understanding of the organization’s end-to-end technology ecosystem and its impact on financial reporting, staying current on system changes, policies, regulatory guidance, and industry best practices
Own audit oversight for system implementations, technology transformations, and process automation initiatives, partnering cross-functionally to ensure controls-by-design, strong SDLC governance, and scalable SOX-readiness from pre-go-live through post-implementation
Lead cloud infrastructure audits across AWS and GCP environments, assessing controls over access management, network security, encryption, logging and monitoring, configuration management, and data residency
evaluate cloud-native security tools and drive control maturity
Drive AI-powered automation of internal controls testing by integrating with IAM platforms (e.g., Okta, AWS IAM) and GitLab to continuously monitor access risks, code changes, and CI/CD controls
leverage AI/ML and automation to detect anomalies and generate audit-ready evidence that enables continuous auditing and improves precision, coverage, and efficiency
Establish and maintain an AI controls automation governance framework, including model validation standards, quality thresholds, and human-in-the-loop checkpoints to ensure accuracy, auditability, and regulatory defensibility
Assess control deficiencies, perform root cause analysis, and drive remediation efforts to closure, including validation and re-testing of corrective actions
Coordinate with co-sourcing partners, external auditors, and control owners to ensure cohesive execution

What we offer

Health insurance
equity awards
life insurance
disability benefits
parental leave
wellness benefits
paid time off
global access to mental health and financial wellness support and resources
healthcare (medical, dental, and vision)
life, accident, disability, commuter, and retirement options (401(k)/pension)

Fulltime

Risk & Governance Manager

We're building something unprecedented: the UK's largest mobile network, created...

Location

United Kingdom , Newbury

Salary:

Not provided

Vodafone

Expiration Date

Until further notice

Requirements

Strong commercial influence, able to shape business narratives that articulate the value of governance, compliance and data driven risk reduction
Deep experience designing and embedding data risk management frameworks, ideally aligned to enterprise risk functions
Proven leadership in federated governance models, driving behavioural change and accountability across diverse functions
Solid understanding of platform level guardrails, including Collibra, Satori, GCP IAM/access patterns and BI tooling
Highly outcome focused, translating policy into measurable service levels, adoption targets and tangible improvements in delivery speed and safety
Skilled at simplifying complexity, enabling teams to adopt governance practices without friction and with clear business benefit

Job Responsibility

Lead the execution of the UK Data Governance & Risk strategy, defining KPIs that balance delivery speed with enterprise grade safety and compliance
Shape and deliver executive level risk storytelling, providing a single, coherent view of data risks and their commercial and regulatory impact into senior forums
Translate emerging risks into practical governance and guardrails, approving standards and driving rapid control design and rollout across key platforms (GCP, EDW, Satori, Collibra, Tableau/Strategy)
Influence and mature the federated data operating model, strengthening business ownership and stewardship while removing bottlenecks through targeted enablement
Champion automation across workflows, lineage, data quality and access orchestration, prioritising investments that reduce manual effort and accelerate cycle times
Partner with Operations, Quality, Privacy, Cyber, Platform and Analytics teams to embed governance into everyday delivery and ensure safe, scalable data product development
Maintain strong relationships with auditors and regulators, ensuring governance practices stand up to scrutiny and support a best in class risk posture

What we offer

Excellent basic salary plus bonus and Vodafone benefits
Up to 28 days off plus bank holidays
Paid time for charity work
Discounts
Vouchers
Pension plan
Learning tools
Top-notch parental leave policies

Fulltime

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

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GCP Quality Auditor

Job Description

Job Responsibility

Requirements

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