Regulatory specialist Work, Jobs in Summertown, Oxf (with Salaries)

Quality Assurance Specialist
Oxford Nanopore Technologies —Oxford
- Full-time
- Bachelor's degree
- Organisational skills
- SharePoint
Imaging Scientist II
Perspectum —Oxford
- £45,000 - £55,000 a year
- Full-time
- Doctoral degree
- Master's degree
- Analysis skills
Quick apply
Technical Application Specialist (Ideal role for a Biomedical Scientist)
Abbott Laboratories —Witney
- Full-time
- Laboratory experience
- Bachelor's degree
- Travel
6d
Field Trials Specialist
Wild Bioscience —Abingdon
- Full-time
- Hybrid work
- Data analysis skills
- Travel
- In-person
Quick apply
12d
Senior Specialist Regulatory Affairs
Abbott Laboratories —Witney
- Full-time
- Maintenance
- Bachelor's degree
- Communication skills
Senior Project Specialist, Clinical Supplies
Moderna, Inc. —Oxford
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Outlook
- Annual leave
Centre Manager - Banbury Lodge
UK Addiction Treatment Centres —Banbury
- £45,000 - £50,000 a year
- Full-time
- Microsoft Outlook
- Management
- Microsoft Office
Quick apply
Quality Systems Coordinator
Oxford Nanopore Technologies —Oxford
- Full-time
- Administrative experience
- Continuous improvement
- Communication skills
Senior Regulatory Affairs Specialist
Kenvue —Reading
- Hybrid work
- English
- Bachelor's degree
- Organisational skills
- Annual leave
Research Project Scientist
University of Oxford —Oxford
- £49,119 - £58,265 a year
- Full-time
- Doctoral degree
- Project management
- IT
13d
Deputy Headteacher
Outcomes First Group —Lillingstone Dayrell
- Up to £55,000 a year
- Monday to Friday
- Education
- Leadership
- Communication skills
- Employee discount
AI Transformation Specialist
Invesco —Henley on Thames
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- AI
- Annual leave
- Life insurance
13d
Senior Fraud Investigator
Nationwide Building Society —Swindon
- From £33,000 a year
- Full-time
- Financial services
4d
Facilities Management and Compliance Lead
SouthOxfordshireAndVale —Abingdon
- £52,892 - £58,923 a year
- Maintenance
- Project management
- Continuous improvement
- Flexible schedule
Quick apply
11d
Project Administrator
SOCOTEC UK & Ireland —Bicester
- Full-time
- Hybrid work
- Microsoft Office
- IT
- Communication skills
- Employee assistance programme
- Employee discount
Quick apply
Remote Pilot Specialist
Skyports Limited —Aylesbury
- £35,000 - £45,000 a year
- Full-time
- Hybrid work
- Up to 50% travel
- Travel
Quick apply
Assistant Water quality scientist/Water quality scientist
AtkinsRéalis —Oxford
- Full-time
- Hybrid work
- Data analysis skills
- Driving
Account Manager
Equans —Oxford
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Annual leave
- Employee assistance programme
Clinical Research Fellow in Gastroenterology
University of Oxford —Oxford
- £38,831 - £73,992 a year
- Full-time
- Bachelor's degree
- Organisational skills
- Annual leave
7d
Product Sustainability Specialist m/f/d
TE Connectivity —Swindon
- Microsoft Excel
- Data analysis skills
- Product management
3d

I want to receive the latest job alerts for regulatory specialist in summertown, oxf

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Quality Assurance Specialist

Oxford Nanopore Technologies -
Oxford

Apply Now

Job details

Permanent | Full-time

Qualifications

Quality management
ISO 9001
Quality assurance
Bachelor's degree
Usability
Organisational skills
SharePoint
Root cause analysis
Communication skills

Full job description

Quality Systems Specialist

Oxford, UK, Hybrid

Oxford Nanopore Technologies (ONT) develops and manufactures innovative nanopore-based sequencing technologies for global research, biopharma, and IVD markets. Operating under ISO 13485 and ISO 9001 quality management systems, ONT ensures compliance with global regulatory requirements.

A sub-team of the QARA department, the Quality Systems team is responsible for ensuring that systems and processes are integrated across all departments and projects, promoting consistency and continuous improvement across the firm.

The Quality Assurance Specialist is responsible for the review and approval of key quality system records and activities within the Quality Management System (QMS), ensuring compliance with internal procedures and applicable regulatory standards (including ISO 13485 and ISO 9001).

In addition, the role is accountable for driving end-user adoption and effective utilisation of the company's electronic QMS (eQMS), and for increasing quality awareness across the organisation. The post holder will lead initiatives to improve engagement, understanding, and consistency in the application of quality processes.

The role acts as a quality gatekeeper, QMS adoption lead, and quality culture champion, providing both operational oversight and organisational influence.

Key Responsibilities

Quality Event Review and Approval

Review and approve Change Control and Deviation requests, Nonconformance reports, CAPA records

Critically assess Root Cause Analysis, Risk Assessments, proposed corrective and preventive actions

Ensure timely progression and closure of quality events

Escalate significant quality or compliance risks

eQMS Adoption and User Engagement

Act as the lead for end-user adoption of the eQMS (e.g. MasterControl)

Develop and maintain training materials, user guides and support resources

Deliver or coordinate training to drive effective system use

Design, initiate, and manage user feedback mechanisms (e.g. surveys)

Quality Awareness and Culture Development

Lead initiatives to increase quality awareness across the organisation

Plan and organise Quality Week and engagement events

Develop and streamline GxP training materials to improve accessibility and effectiveness

Draft and deliver QA communications, updates and newsletters

QA SharePoint and Knowledge Management

Own and manage the QA SharePoint site as a central hub for quality communication and resources

Maintain and update content for organisation-wide audiences (e.g. newsletters, announcements, awareness content) and internal QA users (e.g. quality records, guidance, process resources)

Ensure content is accurate, structured, accessible, and kept up to date

Continually improve site usability and effectiveness as a communication and knowledge platform

Other

Identify and report any quality or compliance concerns

Be aware of and comply with the Quality Manual, Quality Management System, Quality Policy, Quality Goals and applicable regulations as they apply to this job type/position

Provide QA guidance and constructive challenge to ensure compliance

Influence behaviours and promote best practices across the organisation

Provide expert guidance to stakeholders on QMS processes

Any other duties as might be required within the remit and responsibilities of the post

About You

Qualifications/ Education:

B.Sc. Degreeâ€¯in aâ€¯relevantâ€¯STEM disciplineâ€¯or equivalent relevant experience
ISO 9001 orâ€¯ISOâ€¯13485 Internalâ€¯auditor training is desirable
Experience:
At least 3 years experience in a Quality Assurance role within a regulated environment
Experience reviewing and approving Change Controls, CAPAs, Deviations, Nonconformances
Experience developing training content and driving QMS adoption
Experience managing or contributing to internal communications (e.g. newsletters, SharePoint, awareness initiatives)
Knowledge/Skills/Abilities:
Ability to critically assess investigations and challenge effectively
Strong written communication skills (training, newsletters, user content)
Ability to influence stakeholders and drive behavioural change
Strong organisational and information management skills
Analytical mindset (e.g. using feedback to improve systems and engagement)

Attitude/Other Requirements:

Proactive and self-motivated
Positive and collaborative team attitude
Ability to prioritise tasks and manage multiple activities
Ability to work independently in a fast-paced and changeable environment

Join us and help ensure the quality and compliance of technologies transforming genomics and diagnostics globally.

Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.

#LI-LH1

#LI-hybrid

Oxford Nanopore Technologies: Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.

Apply Now

Refine Your Search

regulatory specialist jobs in summertown, oxf

Quality Assurance Specialist

Imaging Scientist II

Technical Application Specialist (Ideal role for a Biomedical Scientist)

Field Trials Specialist

Senior Specialist Regulatory Affairs

Senior Project Specialist, Clinical Supplies

Centre Manager - Banbury Lodge

Quality Systems Coordinator

Senior Regulatory Affairs Specialist

Research Project Scientist

Deputy Headteacher

AI Transformation Specialist

Senior Fraud Investigator

Facilities Management and Compliance Lead

Project Administrator

Remote Pilot Specialist

Assistant Water quality scientist/Water quality scientist

Account Manager

Clinical Research Fellow in Gastroenterology

Product Sustainability Specialist m/f/d

I want to receive the latest job alerts for regulatory specialist in summertown, oxf

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected