Senior Quality Officer (QEs and CAPAs)

TN United Kingdom; Guildford; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Senior Quality Officer to ensure the timely completion of Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) in compliance with global regulations. This role involves leading investigations, supporting operations, and driving continuous improvement projects. With a focus on personal and professional growth, the company fosters a supportive environment that values diversity and collaboration. Join a team where your expertise will contribute to enhancing quality and compliance across the organization, making a meaningful impact in the industry.

Benefits

Internal training and career development opportunities

Focus on personal and professional growth

Friendly, supportive work environment

Opportunity to collaborate with colleagues worldwide

Qualifications

• Relevant experience in a Quality and/or Compliance-related role.
• Experience in Pharmacovigilance, Medical Information, or Medical Devices.

Responsibilities

• Lead the administration, tracking, and management of QEs and CAPAs.
• Coordinate root cause investigation meetings and support Subject Matter Experts.
• Provide training and coaching to junior QE and CAPA team members.

Skills

Quality Management

Root Cause Analysis

Compliance

Pharmacovigilance

Education

University degree in Biomedical Sciences

University degree in Natural Sciences

University degree in Health Sciences

Tools

Electronic Quality Management Systems

Job description

Senior Quality Officer (QEs and CAPAs), Guildford

Location: Guildford, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 6ff1845e5010

Job Views: 4

Posted: 02.05.2025

Expiry Date: 16.06.2025

Job Description

The Senior Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed accurately and timely, and are managed in compliance with global regulations, legislation, and PrimeVigilance requirements.

Responsibilities

1. Lead the administration, tracking, and management of QEs and CAPAs at PrimeVigilance.
2. Coordinate root cause investigation meetings and support Subject Matter Experts in conducting efficient root cause analysis.
3. Manage QEs and CAPAs through their workflow.
4. Support operations and serve as a subject matter expert on managing QEs and CAPAs.
5. Participate in and lead business process optimization and continuous improvement projects.
6. Oversee the timely completion of action items (CAPA and Effectiveness checks) for US project QEs.
7. Participate in audits and inspections as a QE and CAPA SME.
8. Provide training and coaching to business operations and junior QE and CAPA team members.
9. Assist in periodic trending of deviations data across the company.
10. Peer review QE work performed by colleagues.
11. Respond to audit findings and requests.

Qualifications

• University degree in Biomedical Sciences, Natural Sciences, or Health Sciences.
• Relevant experience in a Quality and/or Compliance-related role.
• Experience in Pharmacovigilance, Medical Information, or Medical Devices.
• Experience with electronic Quality Management Systems is desirable but not required.

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where individuals of all backgrounds can contribute and grow.

We believe in a human-first approach, valuing our people as our greatest strength to improve lives.

We offer:

• Internal training and career development opportunities.
• Focus on personal and professional growth.
• A friendly, supportive work environment.
• Opportunity to collaborate with colleagues worldwide, with English as the company language.

Our core values include:

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to receiving your application.