Pharma Quality Assurance Lead

Perspectum Diagnostics Ltd.; Oxford; On-site; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Lead to drive the QA function within their Pharma Solutions unit. This role offers the opportunity to develop and manage a comprehensive Quality Management System (QMS) while ensuring compliance with global regulatory standards. The ideal candidate will thrive in a leadership position, engaging with cross-functional teams to foster a culture of quality and operational excellence. If you are passionate about quality assurance and looking to make a significant impact in the pharma sector, this role is for you.

Qualifications

• Extensive experience in pharma, biotech, or CRO quality assurance roles.
• Strong knowledge of regulatory frameworks and quality standards.

Responsibilities

• Develop and oversee a comprehensive QMS meeting global pharma standards.
• Lead audits and ensure compliance with FDA, MHRA, EMA, and ICH guidelines.

Skills

Quality Assurance

Regulatory Compliance

Problem Solving

Risk Management

Analytical Skills

Leadership

Stakeholder Management

Education

Certified Lead Auditor (ISO 13485:2016 preferred)

Tools

ISO 13485

GMP

GCP

GLP

Job description

Are you a QA expert in pharma looking for an opportunity to lead and shape a function while staying hands-on?

We’re looking for a Quality Assurance Lead to establish, manage, and continuously improve the Quality Management System (QMS) for our Pharma Solutions business unit.

This role is perfect for someone who thrives in an individual contributor leadership position—meaning you’ll have the autonomy to own and drive the QA function while working closely with cross-functional teams to ensure compliance, operational excellence, and a strong quality culture.

About the Role:

1. Develop, and oversee a comprehensive QMS that meets global pharma regulatory standards.
2. Lead audits, regulatory inspections, supplier evaluations, and vendor quality assessments—collaborating with wider compliance teams.
3. Maintain compliance oversight with FDA, MHRA, EMA, and ICH guidelines.
4. Own the CAPA process, ensuring timely and effective resolution of quality issues.
5. Act as a key strategic partner, aligning pharma quality objectives with business goals.
6. Support quality planning for new projects and ensure scalable, sustainable systems.
7. Represent the company in client audits, inspections, and regulatory interactions.
8. Promote a proactive culture of quality and provide expert QA input on client projects and clinical trial operations.

About You:

1. Extensive experience in pharma, biotech, or CRO quality assurance roles.
2. Strong knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 82304-1, GMP, GCP, GLP, and regulatory frameworks.
3. Certified Lead Auditor (ISO 13485:2016 preferred) with a track record of leading audits and implementing CAPA strategies.
4. Strong problem-solving, risk management, and analytical skills.
5. Ability to work autonomously while engaging with cross-functional teams.
6. Exceptional communication, leadership, and stakeholder management abilities.
7. Experience in budget management, project oversight, and process improvements.

About Us:

All our benefits information can be found in the downloadable Benefits document under 'Information' on the right hand side of this screen.

At Perspectum, we are committed to fostering diversity, equity, and inclusion. We prioritise hiring based on merit, skills, and qualifications, valuing individuals for their unique contributions while ensuring a culture that respects and celebrates differences. If you require any reasonable adjustments as part of your application process, please let our Talent Team know.