Audit associate Work, Jobs in Little Marlow, Bkm (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
9d
Junior Engineer - Production
Hypnos Beds —Princes Risborough
- £31,000 - £34,000 a year
- Full-time
- In-person
- Mechanical knowledge
- Employee discount
- Life insurance
Quick apply
19h
Associate Director, Clinical Data Management
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- In-person
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
8d
Associate, Evaluation
European Bank for Reconstruction and Development —London
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
9d
(Fixed-Term) Manufacturing Associate II - Shift Position
Moderna, Inc. —Oxford
- 12 hour shift
- Bachelor's degree
- No degree
- Organisational skills
- Annual leave
Associate, Treasury Accounting
European Bank for Reconstruction and Development —London
- Part-time
- Microsoft Excel
- Data analysis skills
- English
14d
Manager, IT Security Engineering
Gilead Sciences —Uxbridge
- Full-time
- Hybrid work
- Windows
- Master's degree
- Bachelor's degree
GR UK&I Health & Safety Security Manager
Bosch Group —Denham
- Full-time
- Travel
- Organisational skills
- Leadership
Quick apply
General Practice Assistant
The Cambridge Practice —Aldershot
- £13 - £14 an hour
- Full-time
- Care plans
- Nursing
- Health & wellbeing programme
- Employee discount
Quick apply
6d
Cloud DevOps Engineer
Warner Leisure Hotels —Hemel Hempstead
- Up to £55,000 a year
- Full-time
- Hybrid work
- DevOps
- Hotel
- AWS
13d
Sr. Principal Analyst, Microsoft Contract Negotiations & Licensing
Gartner —Egham
- Full-time
- Remote
- Oracle
- AWS
- Analysis skills
7d
SAP PLM Architect (Lead)
Mars —Slough
- Full-time
- Computer Science
- Engineering
- Analysis skills
Associate Quality and Systems Manager – (Asbestos, Fire & Water)
Tetra Tech —Abingdon
- Hybrid work
- Travel
- Leadership
7d
Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK
Cepheid —Amersham
- Full-time
- Remote
- Master's degree
- Bachelor's degree
- Annual leave
6d
Associate Director Quality - Client Dedicated- Regional Clinical Compliance Inspection
IQVIA —Reading
- English
- Microsoft Office
- Bachelor's degree
18h
CSS Field Service Engineer
Roke Manor Research Limited —Woking
- Military
- Engineering
- Driving
CSS Field Service Engineer
Roke —Woking
- Full-time
- Military
- Engineering
- Driving
Onsite Warehouse Support Specialist
ShipBob, Inc. —Abingdon
- Full-time
- English
- IT
- In-person
Quick apply
Education & Training Lead
Mars —Slough
- Full-time
- Bachelor's degree
- Leadership
12d

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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
9 days ago

Qualifications

Bachelor's degree
Leadership

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 little marlow, bkm

Associate Director Global CMC QU – Clinical GMP/GDP

Junior Engineer - Production

Associate Director, Clinical Data Management

Associate Director Global CMC QU – Clinical GMP/GDP

Associate, Evaluation

(Fixed-Term) Manufacturing Associate II - Shift Position

Associate, Treasury Accounting

Manager, IT Security Engineering

GR UK&I Health & Safety Security Manager

General Practice Assistant

Cloud DevOps Engineer

Sr. Principal Analyst, Microsoft Contract Negotiations & Licensing

SAP PLM Architect (Lead)

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

Principal Regulatory Affairs Specialist (UK, IVDR) Remote UK

Associate Director Quality - Client Dedicated- Regional Clinical Compliance Inspection

CSS Field Service Engineer

CSS Field Service Engineer

Onsite Warehouse Support Specialist

Education & Training Lead

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