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

New

Swedish Language Expert & Complaints Associate

Are you fluent in Swedish? Would you like to fire up your career by working as a...

Location

Greece , Athens

Salary:

1450.00 EUR / Month

Randstad

Expiration Date

December 30, 2026

Requirements

Eligible to work in Greece
An exceptional level in the Swedish Language
Advanced English skills
Excellent verbal & written communication skills
PC literacy

Job Responsibility

Manage incoming requests & ensure an utmost customer satisfaction
Resolve customer inquiries regarding customer suggestions
Provide accurate, valid & complete information by using the right methods/tools
Build sustainable relationships of trust through open & interactive communication
Promote additional features relevant to the client’s new services & training material
Verify and correct machine-generated translations of answers to customer queries
Understand and translate the meaning and tone of written words from one language to another
Recognize and provide feedback on issues found in the email

Fulltime

New

Romanian speaking travel agent

Are you fluent in Romanian? Would you like to fire-up your career by working as ...

Location

Greece , Athens

Salary:

Not provided

Randstad

Expiration Date

December 30, 2026

Requirements

High adaptability in dynamic working environments & rotating shifts
Strong communication skills, both written and verbal
Client-centric mindset
Ability to identify customer needs and resolve issues
Results-oriented, highly organized
An exceptional level in the Romanian language
Advanced English skills
PC literacy

Job Responsibility

Manage incoming requests & ensure an utmost customer satisfaction
Resolve customer inquiries regarding guest’s booking
Provide accurate, valid & complete information by using the right methods/tools
Build sustainable relationships of trust through open & interactive communication

New

Science Teacher

Are you an experienced specialist in Biology, Chemistry, or Physics with a QTS? ...

Location

United Kingdom , Liverpool

Salary:

Not provided

Randstad

Expiration Date

April 08, 2026

Requirements

Qualified Teacher Status (QTS)
A degree in Biology, Chemistry, Physics, or a related Science subject
Experience teaching the UK Secondary Science curriculum
A valid DBS check (or the willingness to apply for a new one)

Job Responsibility

Plan and deliver engaging Science lessons that follow the National Curriculum for KS3 and KS4 students
Manage classroom behaviour effectively to create a focused learning environment
Assess student work and provide simple feedback to help them improve
Prepare students for their GCSEs and practical assessments
Collaborate with the Science department to share resources and ideas
Ensure all laboratory health and safety regulations are strictly followed
Support student well-being and act as a positive mentor within the school

What we offer

Referral Bonus
'Refer a Friend' Scheme to earn £300 in shopping vouchers
Access to Continuous Professional Development (CPD) courses to enhance your skills

New

Science Teacher

Position yourself at the heart of South Wirral! We are looking for Qualified and...

Location

United Kingdom , Bromborough

Salary:

Not provided

Randstad

Expiration Date

April 08, 2026

Requirements

Qualified Teacher Status (QTS)
A degree in Biology, Chemistry, Physics, or a related Science subject
Experience teaching the UK Secondary Science curriculum
A commitment to lab safety and student engagement
A valid DBS check (or the willingness to apply for a new one)

Job Responsibility

Plan and deliver engaging Science lessons that follow the National Curriculum for KS3 and KS4 students
Manage classroom behaviour effectively to create a focused learning environment
Assess student work and provide simple feedback to help them improve
Prepare students for their GCSEs and practical assessments
Collaborate with the Science department to share resources and ideas
Ensure all laboratory health and safety regulations are strictly followed
Support student well-being and act as a positive mentor within the school

What we offer

Competitive Pay
'Refer a Friend' Scheme to earn £300 in shopping vouchers
Access to Continuous Professional Development (CPD) courses to enhance your skills

New

Science Teacher

Join a vibrant secondary school community in the heart of Birkenhead. We are loo...

Location

United Kingdom , Birkenhead

Salary:

Not provided

Randstad

Expiration Date

April 08, 2026

Requirements

Qualified Teacher Status (QTS)
A degree in Biology, Chemistry, Physics, or a related Science subject
Experience teaching the UK Secondary Science curriculum
A commitment to lab safety and student engagement
A valid DBS check (or the willingness to apply for a new one)

Job Responsibility

Plan and deliver engaging Science lessons that follow the National Curriculum for KS3 and KS4 students
Manage classroom behaviour effectively to create a focused learning environment
Assess student work and provide simple feedback to help them improve
Prepare students for their GCSEs and practical assessments
Collaborate with the Science department to share resources and ideas
Ensure all laboratory health and safety regulations are strictly followed
Support student well-being and act as a positive mentor within the school

What we offer

Referral Bonus
'Refer a Friend' Scheme to earn £300 in shopping vouchers
Access to Continuous Professional Development (CPD) courses

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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