Clinical director Work, Jobs in 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
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
Director, Portfolio Development Process & Standards Lead
CSL Behring —Maidenhead
- £230,000 - £270,000 a year
- Full-time
- Hybrid work
- Nursing
- Master's degree
- Bachelor's degree
Clinical Trainer UK & Europe - London area
Lumenis —High Wycombe
- Weekend availability
- English
- Travel
- Communication skills
Quick apply
da Vinci Cardiovascular Program Specialist
Intuitive Surgical —Reading
- Day shift
- Nursing
- Sales
- Bachelor's degree
Deputy Chief People Officer
Hampshire Hospitals NHS Foundation Trust —Basingstoke
- £112,782 - £129,783 a year
- Full-time
- Continuous improvement
- Recruiting
- Contracts
Clinic and Medispa operational manager.
Aura medispa ltd —Henley on Thames
- From £16 an hour
- Part-time
- Social media management
- Research
- Business development
- Free parking
- Profit sharing
Quick apply
3d
Director of Transformation
Kingston and Richmond NHS Foundation Trust —Kingston upon Thames
- £118,919 - £135,920 a year
- Full-time
- Master's degree
- Continuous improvement
- No degree
5d
Business Development Director (Clinical Research), UK and Nordics
Ergomed —Guildford
- Full-time
- Remote
- Sales
- Business development
- Analysis skills
Quick apply
Senior Regulatory Affairs Specialist
Kenvue —Reading
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
- Annual leave
Sr Director, Clinical Strategic Operations, Large Pharma Partnership
IQVIA —Reading
- Full-time
- Hybrid work
- Sales
- Customer service
- Business development
8d
ADHD Independent Prescriber
Skylight Psychiatry —Basingstoke
- £65 an hour
- Remote
- Windows
- Communication skills
Sr Director, Drug Development Lead
IQVIA —Reading
- Full-time
- Remote
- Management
- Doctoral degree
- Master's degree
- Work from home
4d
Senior Benefits Risk Management Lead
Bayer —Reading
- £110,000 - £130,000 a year
- Full-time
- Hybrid work
- English
- Databases
- Continuous improvement
- Annual leave
- Employee discount
Senior Director, Search & Evaluation Late TA Lead, Immunology
CSL Behring —Maidenhead
- £263,000 - £328,000 a year
- Full-time
- Doctoral degree
- Master's degree
Senior Director, Drug Development
IQVIA —Reading
- Full-time
- Remote
- Microsoft Powerpoint
- Master's degree
- Business development
- Work from home
Programme Director – UEC Improvement and Transformation
Hampshire Hospitals NHS Foundation Trust —Basingstoke
- £112,782 - £129,783 a year
- Full-time
14d
Principal Investigator
Velocity Clinical Research, Inc. —High Wycombe
- Full-time
- Travel
Quick apply
Sr. Clinical Data Manager (Netherlands, United Kingdom)
Allucent —Bracknell
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Bachelor's degree
- Training & development
- Flexible schedule
- Referral programme
Quick apply
General Manager – General Surgery & Services
Buckinghamshire Healthcare NHS Trust —Aylesbury
- £66,582 - £77,368 a year
- Full-time
- Business development
- Annual leave
18h

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clinical director jobs near marlow, bkm

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

clinical director jobs in marlow, bkm

Associate Director Global CMC QU – Clinical GMP/GDP

Associate Director Global CMC QU – Clinical GMP/GDP

Director, Portfolio Development Process & Standards Lead

Clinical Trainer UK & Europe - London area

da Vinci Cardiovascular Program Specialist

Deputy Chief People Officer

Clinic and Medispa operational manager.

Director of Transformation

Business Development Director (Clinical Research), UK and Nordics

Senior Regulatory Affairs Specialist

Sr Director, Clinical Strategic Operations, Large Pharma Partnership

ADHD Independent Prescriber

Sr Director, Drug Development Lead

Senior Benefits Risk Management Lead

Senior Director, Search & Evaluation Late TA Lead, Immunology

Senior Director, Drug Development

Programme Director – UEC Improvement and Transformation

Principal Investigator

Sr. Clinical Data Manager (Netherlands, United Kingdom)

General Manager – General Surgery & Services

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