Associate director global patient Work, Jobs in Watlington, Oxf (with Salaries)

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
9d
Associate Director, Internal Communications and Engagement
CSL Seqirus —Maidenhead
- Full-time
- Bachelor's degree
- Travel
- Leadership
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
10d
Associate Director Quality - Client Dedicated- Regional Clinical Compliance Inspection
IQVIA —Reading
- English
- Microsoft Office
- Bachelor's degree
1d
Associate Director Quality - Client Dedicated ( Regional Clinical Compliance Lead)
IQVIA —Reading
- Management
- English
- Microsoft Office
1d
Associate Director, Commercial Launch and Project Management
Regeneron —Uxbridge
- Hybrid work
- PMP
- Microsoft Office
- Master's degree
- Annual leave
Local Study Associate Director
IQVIA —Reading
- Patient monitoring
- English
- Project management
8d
Director, Medical Affairs (Europe & International)
Immunocore —Oxford
- Doctoral degree
- Travel
- Patient care
Specialist, R&D Contracts & Business Operations
CSL Behring —Maidenhead
- Full-time
- Bachelor's degree
- Organisational skills
- Contracts
Associate Director, Clinical Data Management
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- In-person
Associate Director, Medical Safety Assessment Physician, Cell Therapy
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Analysis skills
- Travel
- In-person
8d
Associate Director, Medical Affairs
CSL Behring —Maidenhead
- Full-time
- Doctoral degree
Associate Director, GRA Policy EMEA/RoW Lead
Kyowa Kirin International —Marlow
- £66,814 - £134,641 a year
- Full-time
Quick apply
Associate Director, Medical Affairs
Gilead Sciences —Uxbridge
- Full-time
- Doctoral degree
- Analysis skills
- Travel
18h
Associate Director, Data Science
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Azure
- Management
- Doctoral degree
Associate Director, GRA Policy EMEA/RoW Lead
Kyowa Kirin International plc —Marlow
- Full-time
Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based
Moderna, Inc. —Oxford
- Weekend availability
- Microsoft Powerpoint
- Doctoral degree
- Data analysis skills
- Annual leave
Senior Director - Assistant Global Controller
Cytiva —Little Chalfont
- Full-time
- Annual leave
9d

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Associate Director Global CMC QU – Clinical GMP/GDP

Kyowa Kirin International -
Marlow

Quick apply

Job details

Permanent | Full-time
£66,814 - £134,641 a year
9 days ago

Qualifications

Bachelor's degree
Leadership

Full job description

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)

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

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

Quick apply

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associate director global patient jobs in watlington, oxf

Associate Director Global CMC QU – Clinical GMP/GDP

Associate Director, Internal Communications and Engagement

Associate Director Global CMC QU – Clinical GMP/GDP

Associate Director Quality - Client Dedicated- Regional Clinical Compliance Inspection

Associate Director Quality - Client Dedicated ( Regional Clinical Compliance Lead)

Associate Director, Commercial Launch and Project Management

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Director, Medical Affairs (Europe & International)

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Associate Director, Clinical Data Management

Associate Director, Medical Safety Assessment Physician, Cell Therapy

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Associate Director, GRA Policy EMEA/RoW Lead

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

Senior Director - Assistant Global Controller

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