Associate director, structural engineer water Work, Jobs in Dunstable, Bdf (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, Corporate Communications
European Bank for Reconstruction and Development —London
11d
Operations Manager
Brownbill Associates —Thame
- Full-time
- Continuous improvement
- Team management
- Case management
- Annual leave
- Employee assistance programme
Quick apply
Associate Director - Sports & Major Events
Steer —Hemel Hempstead
- Full-time
- Hybrid work
- Business development
- Analysis skills
- Travel
- Annual leave
- Employee assistance programme
Quick apply
European Technical Associate Director – Global VAT Compliance and Reporting
RSM UK —Milton Keynes
- Full-time
- Hybrid work
- Business development
- Analysis skills
7d
Sustainability Manager
Wickes —Watford
- Full-time
- Presentation skills
- Training & development
- Communication skills
- Employee assistance programme
- Employee discount
Capital Markets Associate
Enra Specialist Finance —Watford
- Bachelor's degree
- Communication skills
- Annual leave
Pensions Associate
DHL —Bedford
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
11d
Associate Director - Project Management (7 month fixed term contract)- Channel Performance
Ipsos —Milton Keynes
- Hybrid work
- Team management
- Mentoring
- Budgeting
- Annual leave
16h
Head of Structural Engineering – UK & Ireland
AECOM —St Albans
- Full-time
- Hybrid work
- Business development
- Leadership
- Communication skills
Associate Director / Director, Medicinal Chemistry (ADCs)
Pharmaron —Hoddesdon
- Doctoral degree
- Business development
- Leadership
Associate Director Private & Trusts Assurance
Grant Thornton UK LLP —Milton Keynes
- Full-time
- Mentoring
- Tax experience
- Employee discount
Associate Director-Observer (12 month FTC)
Ipsos —Harrow
- Full-time
- Business development
- AI
- Analytics
- Annual leave
7d
Fire, Health and Safety Manager
London North West University Healthcare NHS Trust —London
- Full-time
- University
- Hospice
11d
Clinical Lead
Brownbill Associates —Thame
- Full-time
- Hybrid work
- Business development
- Supervising experience
- Case management
- Employee assistance programme
- Referral programme
Quick apply
Vice President / Associate Director, Crisis & Risk
Edelman —London
- Full-time
Senior Fire Protection Engineer
AECOM —St Albans
- Full-time
- Hybrid work
- Engineering
- Master's degree
- Analysis skills
Principal Banker
European Bank for Reconstruction and Development —London
- English
- Master's degree
- Business development
14d
Senior Consultant - Transport Planning
AECOM —St Albans
- Full-time
- Hybrid work
- Engineering
- Master's degree
- Business development
Senior Accountant
Accounts Navigator —Potters Bar
- Up to £45,000 a year
- Part-time
- Hybrid work
- Communication skills
- Work from home
- Referral programme
Quick apply
4d

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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

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

associate director, structural engineer water jobs in dunstable, bdf

Associate Director Global CMC QU – Clinical GMP/GDP

Associate, Corporate Communications

Operations Manager

Associate Director - Sports & Major Events

European Technical Associate Director – Global VAT Compliance and Reporting

Sustainability Manager

Capital Markets Associate

Pensions Associate

Associate Director - Project Management (7 month fixed term contract)- Channel Performance

Head of Structural Engineering – UK & Ireland

Associate Director / Director, Medicinal Chemistry (ADCs)

Associate Director Private & Trusts Assurance

Associate Director-Observer (12 month FTC)

Fire, Health and Safety Manager

Clinical Lead

Vice President / Associate Director, Crisis & Risk

Senior Fire Protection Engineer

Principal Banker

Senior Consultant - Transport Planning

Senior Accountant

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