Local Quality Manager UK & Ireland CSL Vifor

Job Description

As the Local Quality Manager for UK and Ireland within the CSL Vifor function, you will be responsible for ensuring the quality for the distribution of pharmaceutical products by CSL Vifor and partners in the UK and Ireland. In this role, you report directly to the CSL Vifor Lead Quality Affiliate & Partners West. The role is office based with hybrid working.

You will collaborate with the local safety office, medical affairs, distributors, and vendors. Experience in inspection readiness is required for this role. Hybrid/flexible working is offered. For additional information, please read thoroughly and apply.

Responsibilities include:

1. Oversee all GxP compliance procedures related to GxP legislation and monitor adherence from a QA perspective.
2. Ensure that all relevant activities and materials produced by VPUK comply with Vifor Pharma SOPs, policies, guidelines, procedures, and relevant local legislation.
3. Coordinate and manage the system for maintaining procedures and processes.
4. Develop, manage, and maintain tracking, records, and filing systems.
5. Monitor processes to ensure effective business objectives are met while maintaining and improving GxP compliance.
6. Coordinate the preparation and execution of external and internal GxP (Good Distribution Practices and Good Documentation Practices) compliance audits.
7. Train and mentor VPUK staff members regarding GxP procedures as required.
8. Oversee the review, update, and maintenance of regulatory documents in accordance with SOPs and local legislation, including product licenses.
9. Undertake internal compliance audits of procedures related to GxP.
10. Maintain tracking, electronic, and hard copy filing of supplier contracts/agreements.
11. Assist in drafting and checking quality agreements.

Qualifications, Skills, and Competencies:

• Degree in pharmacy or life sciences, or equivalent.
• Experience with MHRA inspections.
• 2-3 years’ experience in the pharmaceutical industry or relevant experience.
• Understanding of pharmacovigilance systems and the regulatory environment.
• Knowledge of and involvement in GxP processes (Good Distribution Practices and Good Documentation Practices).
• Experience conducting and managing audits.
• Ability to analyze data and communicate clearly, both orally and in writing.
• Ability to prioritize and attention to detail.
• Effective problem-solving skills.
• Ability to work independently and oversee multiple tasks.

About CSL Vifor: CSL Vifor aims to become the global leader in iron deficiency and nephrology. The company partners in pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology, and rare conditions.

CSL Vifor strives to help patients worldwide with severe, chronic, and rare diseases lead better, healthier lives. It specializes in global partnering, in-licensing, development, manufacturing, and marketing of pharmaceutical products for precision patient care. For more information, visit viforpharma.com.

We want CSL to reflect the world around us. As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about us at CSL. Do work that matters at CSL Vifor!