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

Support Worker

This specialist supported living service has been purpose-built for young adults...

Location

United Kingdom , Church Stretton, Shrewsbury

Salary:

12.39 GBP / Hour

Brook-St Hiredonline

Expiration Date

Until further notice

Requirements

Full UK manual driving licence held for at least 1 year
Access to your own vehicle (rural location)
Passionate about supporting people to live happy, fulfilled lives
Patient, caring, and a good listener
Confident communicator with individuals and families
Able to promote independence and daily living skills
Good IT skills and ability to use digital systems
Able to work independently and use initiative

Job Responsibility

Support individuals with daily living and independence skills
Promote inclusion and engagement in the wider community
Provide personal care where required
Build positive, trusting relationships with individuals and their families
Encourage participation in social and community activities
Work collaboratively within a supportive team environment

What we offer

Competitive hourly pay
High-quality training provided
Comprehensive induction with shadow shifts
28 days holiday in year one, increasing with service
Free and confidential counselling services
Health Cash Plan covering dental, optical, physio & more
Long service awards
Contributory pension scheme
Clear career development and progression opportunities
Regular supervision and team meetings

New

Marketing designer

Fundraise Up is a modern fundraising platform built to make donating to nonprofi...

Location

Serbia

Salary:

375000.00 - 445000.00 RSD / Month

Fundraise Up

Expiration Date

Until further notice

Requirements

5+ years of experience in communication or brand design
Strong understanding of how design solves business problems and communicates brand values
AI as a working tool: hands-on experience using neural networks to speed up workflows, generate assets, and optimize routine tasks (practical skills over theory)
Strong illustration skills: ability to draw by hand and advanced proficiency in Figma (working with complex gradients, shadows, and lighting)
Web & Marketing: experience designing websites, solid understanding of landing pages and marketing funnels
Multiformat experience: creating presentations, designing for offline events (booths, print materials), and basic motion design (building simple animations, tweaking easings)
Conversational English (B2)

Job Responsibility

Develop and evolve the brand’s visual ecosystem (website, blog, social media), owning storytelling and translating complex ideas into clear, accessible metaphors
Create graphic content and illustrations, actively leveraging AI tools to accelerate production workflows
Produce materials for conferences and events — from merchandise and booth design to motion videos
Collaborate closely with the team to ensure visual consistency across all channels

What we offer

31 days off
100% paid telemedicine plan
Home Office Setup Assistance: the company offers assistance with purchasing furniture (office chair, office desk, monitor) and other items to create a comfortable workspace
English learning courses
Relevant professional education
Gym or swimming pool
Co-working
Remote working
Stock options

Fulltime

New

Marketing designer

Fundraise Up is a modern fundraising platform built to make donating to nonprofi...

Location

Georgia

Salary:

8000.00 - 10800.00 GEL / Month

Fundraise Up

Expiration Date

Until further notice

Requirements

5+ years of experience in communication or brand design
Strong understanding of how design solves business problems and communicates brand values
AI as a working tool: hands-on experience using neural networks to speed up workflows, generate assets, and optimize routine tasks (practical skills over theory)
Strong illustration skills: ability to draw by hand and advanced proficiency in Figma (working with complex gradients, shadows, and lighting)
Web & Marketing: experience designing websites, solid understanding of landing pages and marketing funnels
Multiformat experience: creating presentations, designing for offline events (booths, print materials), and basic motion design (building simple animations, tweaking easings)
Conversational English (B2)

Job Responsibility

Develop and evolve the brand’s visual ecosystem (website, blog, social media), owning storytelling and translating complex ideas into clear, accessible metaphors
Create graphic content and illustrations, actively leveraging AI tools to accelerate production workflows
Produce materials for conferences and events — from merchandise and booth design to motion videos
Collaborate closely with the team to ensure visual consistency across all channels

What we offer

31 days off
100% paid telemedicine plan
Home Office Setup Assistance: the company offers assistance with purchasing furniture (office chair, office desk, monitor) and other items to create a comfortable workspace
English learning courses
Relevant professional education
Gym or swimming pool
Co-working
Remote working
Stock options

Fulltime

New

Customer service field agent - driving

Are you seeking a dynamic customer-facing position that offers variety and oppor...

Location

United Kingdom , Coalville, Whitwick

Salary:

12.55 GBP / Hour

Randstad

Expiration Date

February 14, 2026

Requirements

Valid UK Driving License
Owned Car
Willing to complete a DBS
Willing to obtain business car insurance
Willing to travel up to 40 miles
Excellent verbal communication skills and evidence of persuading reluctant respondents to take part in surveys
Self-disciplined, self-motivated, and happy to work with minimum supervision
Be proficient in the use of laptop and smartphone
Can demonstrate ability to be organised with well-developed planning skills
Proficient in using laptop and smartphone to receive, view and input information

What we offer

0.45p per milage
1 meal per 5 hours (£7.50), 2 meals per 10 hours (£15)

Parttime

New

Market Development Executive

Market Development Executive position responsible for exploring the market for l...

Location

Vietnam , Ho Chi Minh City; Hanoi; Da Nang

Salary:

Not provided

Chicilon Media

Expiration Date

Until further notice

Requirements

Bachelor’s degree or higher
Aged between 23 - 30 years old
At least 1 year of experience in sales, market development, or related positions
Preference will be given to candidates with experience or good relationships with real estate project developers
Strong persuasion skills and good negotiation abilities

Job Responsibility

Responsible for exploring the market for leasing advertising installation locations: LCD & Poster Frames
Negotiate and sign contracts
Address customer complaints regarding issues related to the broadcast of advertising content, rental payment, contract addendums, contract renewals, and the transfer of management rights, etc.
Provide customer service and support
Collaborate with relevant departments to handle official documents and resolve any issues that arise
Work according to the assigned plan

What we offer

Working from Monday to Friday, weekends (Saturday & Sunday) off
Working hours: 7.5 hours per day
Lunch allowance
Parking allowance
Annual team-building activities
Work in a dynamic, professional media environment
Public holidays and vacation benefits in accordance with state regulations
Soft skills and professional training provided

Fulltime

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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