Senior QMS Compliance Lead – QA & Audits

Aspire Pharma; Cambourne; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Company pension scheme

CSR days

Life Assurance

25 days’ holiday

Learning and development opportunities

progression opportunities

Company events

Cycle to Work Scheme

Private healthcare schemes

Job summary

Aspire Pharma is a rapidly growing UK pharmaceutical manufacturer based near Petersfield or Leicester. We are seeking a Principal QMS Compliance Lead to manage day-to-day QMS activities and ensure all Quality Control and Assurance tasks meet ISO 9001, ISO 13485, and ISO 14971 requirements.

The role includes line management, regulatory liaison, and leading internal audits. A Graduate with 4+ years QA experience is preferred, with strong English skills and MS Office proficiency.

Qualifications

• Written and spoken English with good communication skills.
• Time management abilities for coordinating QMS tasks.
• Attention to detail in document control and change management.
• Proven ability to lead a team and train staff.

Responsibilities

• Oversee and ensure QMS compliance across Irish/EU and UK GXP/ISO standards.
• Manage a Home team, ensuring staff have up-to-date roles and development plans.
• Report to Quality Department and Quality Compliance Manager on performance and issues.
• Liaise with Regulatory Authorities, Notified Bodies, and suppliers on changes and audits.

Skills

English

Communication Skills

Time Management

Attention to Detail

Team Management

MS Office

Q Pulse

Education

Graduate

Tools

Q Pulse

Job description

Aspire Pharma is a rapidly growing UK pharmaceutical manufacturer based near Petersfield or Leicester. We are seeking a Principal QMS Compliance Lead to manage day-to-day QMS activities and ensure all Quality Control and Assurance tasks meet ISO 9001, ISO 13485, and ISO 14971 requirements.

The role includes line management, regulatory liaison, and leading internal audits. A Graduate with 4+ years QA experience is preferred, with strong English skills and MS Office proficiency.