QA Manager, Clinical Development

JR United Kingdom; Egham; Hybrid; GBP 50,000 - 80,000; Full time

Job summary

An established industry player is on the lookout for a Clinical Development QA Manager to lead quality and compliance initiatives across clinical studies. This pivotal role involves maintaining quality strategies, conducting audits, and ensuring adherence to GCP and GMP regulations. With a commitment to niche medicines and a focus on rare diseases, the company fosters a collaborative environment that values professional growth and open communication. If you're passionate about quality assurance and ready to make a significant impact, this opportunity is perfect for you.

Benefits

Flexible Hybrid Working

£150 Home Office Allowance

Competitive Pension Scheme

Life Insurance

Enhanced Family Leave

Sick Pay

Annual Leave

Performance Bonus

Qualifications

• 5+ years of GCP QA experience in clinical trial settings.
• Proven track record in building Quality Management Systems.

Responsibilities

• Develop and maintain quality management systems for clinical activities.
• Conduct audits and manage CAPA processes to ensure compliance.

Skills

GCP QA Experience

GMP Knowledge

Quality Management Systems

Auditing Skills

CAPA Management

Education

Life Science Degree

Equivalent Qualification

Job description

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Essential Pharma is seeking a Clinical Development QA Manager responsible for identifying and mitigating quality and compliance risks across all aspects of clinical studies. The role requires adherence to GCP, GLP, GCLP, GMP, GDP, and GPvP regulations, along with leading internal audits and external inspections.

What You Will Do

1. Maintain a quality strategy aligned with clinical development needs.
2. Develop and maintain a quality management system supporting clinical activities.
3. Drive SOP development to support clinical trial processes.
4. Support GCP through audits of sites, CROs, and documentation.
5. Support GMP by coordinating manufacturer and supplier audits.
6. Coordinate audits and manage CAPA processes.
7. Prepare and review documentation for regulatory submissions.
8. Develop and track quality procedures for staff training and outsourcing.
9. Oversee documentation release and control.
10. Ensure pharmacovigilance quality assurance.
11. Provide training across clinical development phases.
12. Maintain readiness for regulatory inspections.
13. Collaborate to ensure compliance with ICH and local regulations.
14. Report quality updates to Senior Management.
15. Stay updated on regulatory trends and share insights.
16. Manage CAPA activities and monitor closures.
17. Maintain awareness of relevant GxP guidelines across territories.

What We Do

Essential Pharma is an international specialty pharmaceutical company with a focus on niche medicines for small patient populations. Our portfolio includes over 300 medicines across various therapeutic areas, treating patients in more than 70 countries. We focus on rare diseases and late-stage clinical assets, including recent acquisitions and strategic financings.

What You Will Bring

1. Life science degree or equivalent qualification.
2. At least 5 years of GCP QA experience with knowledge of GMP.
3. Experience building and maintaining Quality Management Systems in biotech or clinical trial settings.
4. Significant experience in QA roles within CROs or clinical trial sponsors.
5. Deep understanding of GxP, especially GCP and GMP.

What We Offer

• Flexible hybrid working arrangements.
• £150 home office allowance.
• Competitive pension scheme.
• Life insurance and enhanced family leave.
• Additional benefits including sick pay, annual leave, and performance bonus.

What To Expect

• Inclusive, agile work environment valuing authenticity and collaboration.
• Opportunities for professional growth, personalized development, and open communication with leadership.