Associate Director - Quality Standards and Continuous Improvement

BioSpace; Greater London; Hybrid; GBP 80,000 - 120,000; Full time

Benefits offered by this job

Annual bonuses

Health and wellness programs

401(k) company match

Job summary

BioSpace is seeking an Associate Director, Quality Standards and Continuous Improvement to join their Global Development Quality team in the UK. This hybrid role involves overseeing quality management systems, ensuring compliance, and collaborating with various stakeholders to drive improvements across the organization.

The ideal candidate will have a Bachelor's degree, with over 10 years of experience in the healthcare or pharmaceutical industry, expertise in quality management, and a proven record of leading teams. A competitive rewards package is offered.

Qualifications

• 10 years of relevant healthcare or pharmaceutical industry experience.
• Experience in quality, compliance, quality management, quality assurance or clinical development.
• Experience training and mentoring staff.

Responsibilities

• Oversee the end-to-end Issue Management framework.
• Define and evolve Issue Management and Quality Event strategies.
• Lead and develop line reports while supporting the QEL community.

Skills

Quality management system oversight

Continuous improvement

Team leadership

Good Clinical Practice

Good Pharmacovigilance Practice

Education

Bachelor's degree

Job description

Build our future together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Quality Standards and Continuous Improvement to join our Global Development Quality team, supporting quality management system oversight, governance, quality events and continuous improvement across Global Development. In this role, you will help maintain effective quality standards and processes while collaborating with internal leaders, functional stakeholders and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where

• Location: Uxbridge, Dublin, Warren or Armonk
• Hybrid model

Discover Your Role

• Oversee the end-to-end Issue Management framework, ensuring standardized, compliant, and inspection-ready practices.
• Define and evolve Issue Management and Quality Event strategies to support scalability, efficiency, and consistency.
• Drive cross-functional alignment across Quality Event Leads (QEL) and functional teams to ensure consistent and right sized approach to issue management and quality decision-making.
• Lead QEL forums and provide SME guidance on QMS governance, continuous improvement, and inspection readiness.
• Ensure consistency in investigations, root cause analysis, CAPAs and documentation standards.
• Lead and develop line reports whilst also supporting the broader QEL community through coaching, standard setting, and knowledge sharing.
• Monitor Issue Management performance through metrics and trend analysis.

This Role Requires

• Bachelor's degree with at least 10 years of relevant healthcare or pharmaceutical industry experience.
• Experience in quality, compliance, quality management, quality assurance or clinical development.
• Expertise or transferable skills related to Good Clinical Practice or Good Pharmacovigilance Practice.
• Experience training, supervising, mentoring, developing staff and leading a small team.
• Advanced knowledge of quality management system oversight, quality governance and continuous improvement.
• Experience participating in, managing and leading regulatory agency inspections.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.