Technical author Work, Jobs in High Wycombe, 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
Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based
Moderna, Inc. —Oxford
- Weekend availability
- Microsoft Powerpoint
- Doctoral degree
- Data analysis skills
- Annual leave
Process Discipline Lead - Warrington or Abingdon
Orano —Abingdon
- Full-time
- Hybrid work
- Engineering
- Master's degree
- Bachelor's degree
- Annual leave
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
Principal Scientist, Bioanalytical & Molecular Assays
Moderna, Inc. —Oxford
- Full-time
- Doctoral degree
- Master's degree
- Annual leave
Systems Architect - Global Data Center Segment - IT Module
Eaton —Slough
- Engineering
- System design
- Microsoft Office
Senior Manager, Real-World Evidence (RWE) Biostatistician
Bristol-Myers Squibb —Uxbridge
- Full-time
- Doctoral degree
- Master's degree
- Analysis skills
Senior AMO Physicist
Infleqtion —Harwell
- Full-time
- Hybrid work
- Doctoral degree
- Laboratory experience
- Microsoft Office
- Annual leave
- Work from home
Quick apply
Senior Medical Writer – UK based, London, Nottingham, Reading
Porterhouse Medical Group —Reading
- Bachelor's degree
- Leadership
Manufacturing Engineer III
Pelican Products, Inc. —Leighton Buzzard
- Full-time
- Hybrid work
- Up to 50% travel
- Engineering
- Maintenance
Quick apply
Requirements Analyst
Oxford Nanopore Technologies —Oxford
- Full-time
- Software development
- Communication skills
IT Security Specialist
Montu UK —Winnersh
- £55,000 - £60,000 a year
- Full-time
- Hybrid work
- Python
Quick apply
3d
Senior Commissioning Engineer
Gallifordtry —Rickmansworth
- Full-time
- Microsoft Office
- Leadership
- Employee assistance programme
- Employee discount
Healthcare & Life Sciences Principal, EMEA
Everpure —Staines-upon-Thames
- Business development
- Travel
- Communication skills
4d
Teamcenter Solution Architect
Capgemini Sogeti —Slough
- C++
- JavaScript
- Software development
Mechanical Engineer - Product Design
Safran —Pitstone
- Full-time
- Engineering
- Microsoft Office
- Analysis skills
Teamcenter Solution Architect
Capgemini —Slough
- C++
- JavaScript
- Software development
Senior Solutions Architect (UK)
Lumai —Oxford
- Full-time
- Hybrid work
- Machine learning
- IT
- AI
- Annual leave
Quick apply
Commissioning Engineer - Affinity Water Region
Gallifordtry —Rickmansworth
- Full-time
- Microsoft Office
- Travel
- Mechanical knowledge
- Employee assistance programme
- Employee discount
Mechanical Supervisor
Gallifordtry —Rickmansworth
- Full-time
- Engineering
- Microsoft Office
- Supervising experience
- Employee assistance programme
- Employee discount

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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

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

technical author jobs in high wycombe, bkm

Associate Director Global CMC QU – Clinical GMP/GDP

Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based

Process Discipline Lead - Warrington or Abingdon

Associate Director Global CMC QU – Clinical GMP/GDP

Principal Scientist, Bioanalytical & Molecular Assays

Systems Architect - Global Data Center Segment - IT Module

Senior Manager, Real-World Evidence (RWE) Biostatistician

Senior AMO Physicist

Senior Medical Writer – UK based, London, Nottingham, Reading

Manufacturing Engineer III

Requirements Analyst

IT Security Specialist

Senior Commissioning Engineer

Healthcare & Life Sciences Principal, EMEA

Teamcenter Solution Architect

Mechanical Engineer - Product Design

Teamcenter Solution Architect

Senior Solutions Architect (UK)

Commissioning Engineer - Affinity Water Region

Mechanical Supervisor

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