Local Quality Manager UK & Ireland CSL Vifor

CSL; Maidenhead; Hybrid; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Local Quality Manager for the UK and Ireland. This pivotal role involves ensuring the quality of pharmaceutical product distribution and compliance with GxP standards. You'll collaborate with various stakeholders and manage audits, training, and regulatory documentation. If you have a strong background in the pharmaceutical sector and a passion for quality assurance, this is an exciting opportunity to make a significant impact in a dynamic environment. Join a company dedicated to improving patient outcomes and driving innovation in healthcare.

Qualifications

• 2-3 years of experience in the pharmaceutical industry or relevant field.
• Understanding of pharmacovigilance systems and regulatory environment.

Responsibilities

• Oversee GxP compliance procedures and monitor adherence.
• Coordinate and manage procedures/processes maintenance systems.
• Conduct internal compliance audits related to GxP.

Skills

GxP Compliance

Pharmaceutical Industry Knowledge

Data Analysis

Communication Skills

Problem-solving Skills

Inspection Readiness

Attention to Detail

Education

Degree in Pharmacy

Degree in Life Sciences

Job description

Local Quality Manager UK & Ireland CSL Vifor

Apply locations: Seqirus UK - Maidenhead | Remote | Full time | Posted on: Posted 25 Days Ago | Job requisition id: R-252459

As the Local Quality Manager for the UK and Ireland within CSL Vifor, you will be responsible for ensuring the quality of pharmaceutical product distribution by CSL Vifor and partners in the UK and Ireland. You will report directly to the CSL Vifor Lead Quality Affiliate & Partners West. This role is office-based with hybrid working options. Collaboration with the local safety office, medical affairs, distributors, and vendors is essential. Experience in inspection readiness is required.

Responsibilities include:

1. Oversee all GxP compliance procedures related to legislation and monitor adherence from a QA perspective.
2. Ensure activities and materials produced by VPUK comply with Vifor Pharma SOPs, policies, guidelines, procedures, and relevant legislation.
3. Coordinate and manage procedures/processes maintenance systems.
4. Develop, manage, and maintain tracking, records, and filing systems.
5. Monitor processes to meet business objectives while maintaining GxP compliance.
6. Coordinate preparations and executions for external and internal GxP audits.
7. Train and mentor VPUK staff on GxP procedures as needed.
8. Review, update, and maintain regulatory documents per SOPs and legislation, including product licenses.
9. Conduct internal compliance audits related to GxP.
10. Maintain tracking and filing of supplier contracts and agreements.
11. Assist in drafting and reviewing quality agreements.

Qualifications, Skills, and Competencies:

• Degree in pharmacy, life sciences, or equivalent.
• Experience with MHRA inspections.
• 2-3 years of experience in the pharmaceutical industry or relevant field.
• Understanding of pharmacovigilance systems and regulatory environment.
• Knowledge of GxP processes, including distribution and documentation practices.
• Experience in conducting and managing audits.
• Strong data analysis and communication skills, both oral and written.
• Ability to prioritize tasks effectively.
• High attention to detail and standards.
• Effective problem-solving skills.
• Ability to work independently and manage multiple tasks.

About CSL Vifor

CSL Vifor aims to become a global leader in iron deficiency and nephrology. The company partners in pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology, and rare conditions. It strives to help patients worldwide lead better, healthier lives, specializing in global partnerships, licensing, development, manufacturing, and marketing of pharmaceutical products for precision patient care.

For more information, please visit viforpharma.com.

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