Audit associate Work, Jobs in Barkham, Brk (with Salaries)

Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International plc —Marlow
- £80,000 - £140,000 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Associate Director Global CMC QU – Clinical GMP/GDP
Kyowa Kirin International —Marlow
- £66,814 - £134,641 a year
- Full-time
- Bachelor's degree
- No degree
- Leadership
Quick apply
Associate, Financial Accounting
European Bank for Reconstruction and Development —London
- Part-time
- Computer skills
- Accounting
- Banking
6d
Associate Quality and Systems Manager – (Asbestos, Fire & Water)
Tetra tech Ltd. —Basingstoke
- Hybrid work
- Continuous improvement
- Travel
- Leadership
Quick apply
Associate Pharmacovigilance Project Director (Delivery)- Europe
PrimeVigilance —Guildford
- Full-time
- Remote
- Management
- Conflict management
- Leadership
Quick apply
7d
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Databases
- Bachelor's degree
- Annual leave
Associate Director, People Operations (Europe)
Ergomed —Guildford
- Full-time
- Hybrid work
- English
- Human resources
- Training & development
Quick apply
Clinical Lead
Brownbill Associates —Thame
- Full-time
- Hybrid work
- Business development
- Supervising experience
- Case management
- Employee assistance programme
- Referral programme
Quick apply
Operations Manager
Brownbill Associates —Thame
- Full-time
- Continuous improvement
- Team management
- Case management
- Annual leave
- Employee assistance programme
Quick apply
Lead General Practice Nurse
Kingswood Surgery —High Wycombe
- From £24 an hour
- Part-time
- Supervising experience
- Team management
- In-person
Quick apply
Assistant Manager
Apex Group —Reading
- Full-time
- Mentoring
- Organisational skills
- Annual leave
- Employee assistance programme
Consultant in Emergency Medicine
Hampshire Hospitals NHS Foundation Trust —Basingstoke
- £113,565 - £150,569 a year
- Full-time
- Management
- Research
- Patient care
11d
Night Auditor
Delta Hotels by Marriott Heathrow Windsor —Slough
- £14.10 an hour
- Full-time
- Hospitality
- Hotel
- Front desk
- Free parking
- Employee discount
Quick apply
6d
Lead Drone Surveyor
Survey Solutions —Wokingham
- Full-time
- Hybrid work
- Business development
- Training & development
Quick apply
Clinical Monitoring Lead
Biogen —Maidenhead
- Full-time
- Hybrid work
- Nursing
- Bachelor's degree
- Team management
4d
European Technical Associate Director – Global VAT Compliance and Reporting
RSM UK —Reading
- Full-time
- Hybrid work
- Business development
- Analysis skills
6d
Health, Safety & Environment (HSE) Senior Specialist
Mars —Slough
- £55,000 - £67,000 a year
- Full-time
- Continuous improvement
- Training & development
- Leadership
CSS Field Service Engineer
Roke Manor Research Limited —Woking
- Engineering
- Maintenance
- Continuous improvement
Associate Manager Consumer Products - Softlines (Maternity cover)
Mattel —Slough
- £57,040 - £67,745 a year
- Full-time
- Marketing
- Business development
- No degree
- Annual leave
- Employee assistance programme
Quick apply
Senior Surveyor/Associate | Compulsory Purchase & Compensation
Knight Frank —Hendred
- Full-time
- Business development
- Analysis skills
- Travel

I want to receive the latest job alerts for audit associate in barkham, brk

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Associate Director Global CMC QU – Clinical GMP/GDP

Kyowa Kirin International plc -
Marlow

Apply Now

Job details

Permanent | Full-time
£80,000 - £140,000 a year

Qualifications

Quality management
Bachelor's degree
Clinical trials
Supply chain quality assurance
Pharmaceutical industry setting experience
Leadership
EU Good Distribution Practice (GDP)
Internal quality assurance

Full job description

Overview

Associate Director Global CMC QU – Clinical GMP/GDP

at Kyowa Kirin International plc

Marlow, UK or Hoofddorp, Netherlands

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

You will be responsible for providing end-to-end quality oversight of clinical investigational medicinal products (IMPs) in accordance with EU GMP (EudraLex Volume 4), including Annex 13, and EU GDP Guidelines (2013/C 343/01)

The role provides independent QA oversight and regulatory support to EU Qualified Persons (QPs), ensuring that certification and release of investigational medicinal products is performed in compliance with EU legal and regulatory requirements. The position maintains quality oversight of CDMOs, packaging sites, laboratories, and Third-Party Logistics providers (3PLs) involved in the manufacture, storage, and distribution of clinical trial material (CTM)

Responsibilities

Key Responsibilities:

Provide QA oversight of clinical IMP manufacturing, packaging, testing, release, and distribution activities
Support EU Qualified Person (QP) certification and batch release processes
Ensure compliance with EU GMP Annex 13 requirements, including labeling, traceability, accountability, and retention samples
Review and approve GMP documentation, including batch records, CoAs, deviations, investigations, and quality events
Lead QA support for clinical technology transfers, process start-ups, and product lifecycle activities
Provide quality oversight of clinical supply chain operations, including transportation, temperature-controlled logistics, and distribution
Ensure clinical trial materials remain fully traceable throughout the supply chain.
Manage Quality Technical Agreements (QTAs) with CDMOs, laboratories, distribution partners, and 3PL providers
Plan, conduct, and support risk-based GMP and GDP audits of external partners.
Support regulatory submissions, inspections, and health authority interactions
Author, review, and maintain Clinical GMP/GDP procedures and quality system documentation
Ensure compliance with data integrity requirements, including EU GMP Annex 11 and ALCOA+ principles

Qualifications

Position Requirements:

Bachelor’s degree in a relevant scientific/technical discipline or equivalent experience in the pharmaceutical industry
Solid leadership experience within Pharmaceutical Quality in the pharmaceutical Industry, with significant exposure to EU Clinical GMP and GDP
Prior experience working with a Qualified Person (QP) responsible for investigational medicinal products, as well as experience in batch disposition (release), is preferred for success in this position
Strong knowledge of EU GMP (EudraLex Volume 4, Annex 13) and EU GDP Guidelines
Experience with biologics and/or small molecule clinical products.
Demonstrated ability to assess quality and regulatory risk and provide sound compliance judgments
Experience in QA, QC, auditing, or regulatory affairs within a clinical development environment

UK salary - £80,000-121,000

Netherlands salary - €93,000-140,000

Apply Now

Refine Your Search

audit associate jobs in barkham, brk

Associate Director Global CMC QU – Clinical GMP/GDP

Associate Director Global CMC QU – Clinical GMP/GDP

Associate, Financial Accounting

Associate Quality and Systems Manager – (Asbestos, Fire & Water)

Associate Pharmacovigilance Project Director (Delivery)- Europe

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Associate Director, People Operations (Europe)

Clinical Lead

Operations Manager

Lead General Practice Nurse

Assistant Manager

Consultant in Emergency Medicine

Night Auditor

Lead Drone Surveyor

Clinical Monitoring Lead

European Technical Associate Director – Global VAT Compliance and Reporting

Health, Safety & Environment (HSE) Senior Specialist

CSS Field Service Engineer

Associate Manager Consumer Products - Softlines (Maternity cover)

Senior Surveyor/Associate | Compulsory Purchase & Compensation

I want to receive the latest job alerts for audit associate in barkham, brk

Explore jobs in more locations

Overview

Responsibilities

Qualifications

Jobseeker tools

Employer Tools

Browse

Stay Connected