Associate Director, Quality Assurance, Vendor Management

TN United Kingdom; United Kingdom; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

An established industry player seeks an Associate Director for Quality Assurance and Vendor Management. This pivotal role involves managing a comprehensive QA vendor oversight program to ensure compliance with vital GxP regulations. You will collaborate with global stakeholders, develop audit strategies, and oversee vendor performance to enhance compliance. With a focus on innovative science and patient-centric solutions, this position offers the chance to make a significant impact in the pharmaceutical landscape. Join a progressive health partner committed to excellence and innovation in healthcare.

Qualifications

• Extensive experience in the pharmaceutical or biotech industry.
• Proven expertise in GxP and Quality Management Systems.

Responsibilities

• Manage and oversee QA vendor oversight program.
• Develop and execute QA vendor audit strategies.

Skills

GxP Knowledge

Quality Management Systems

Project Management

Regulatory Compliance

Education

Bachelor's degree in Science

Tools

Microsoft Office

Job description

Job Title: Associate Director, Quality Assurance, Vendor Management

About Astellas:

At Astellas, we are a progressive health partner dedicated to delivering value and outcomes where needed. We focus on innovative science, especially in areas with high patient need, including rare or underserved diseases and life-threatening conditions. We collaborate with patients, healthcare professionals, and regulatory bodies to ensure patient-centric development and access to therapies.

The Opportunity:

This role involves managing and overseeing Astellas’ Quality Assurance (QA) vendor oversight program to ensure compliance with GxP regulations such as GMP, GCP, GVP, GLP, ERES, and CSV. You will define and implement QA vendor audit strategies, assess vendors through risk ranking, and develop strategies to improve vendor performance and compliance.

Key Responsibilities:

1. Contribute to the strategic direction of QA Vendor Management and collaborate with global stakeholders.
2. Develop and execute the QA vendor audit strategy.
3. Lead the creation of vendor audit schedules based on risk and compliance.
4. Oversee vendor audits and communicate vendor status to stakeholders and regulators.
5. Manage vendor risk mitigation and evaluate quality metrics to ensure compliance.

Essential Knowledge & Experience:

• Extensive experience in the pharmaceutical or biotech industry with knowledge of regulatory requirements.
• Proven expertise in GxP and Quality Management Systems, especially regarding vendor oversight.
• Ability to achieve results within tight deadlines and complex environments.
• Experience managing multiple projects simultaneously.
• Deep understanding of GxP requirements throughout product lifecycle.

Preferred Qualifications:

• Experience in auditing and vendor relations.
• Knowledge of Vendor Management throughout the product lifecycle.
• Proficiency in Microsoft Office.

Education/Qualifications:

Bachelor's degree in Science or equivalent.

Additional Information:

• Permanent, full-time position based in London, UK.
• Hybrid working model; approximately 1 day per quarter in the London office.
• Applicants must be within a commutable distance of London.

We are an equal opportunity employer, committed to diversity and inclusion.