Associate Director - Quality Standards and Continuous Improvement

Associate Director - Quality Standards and Continuous Improvement

Full-Time 70000 - 90000 Β£ / year (est.) No working from home possible
BioSpace

At a Glance

  • Tasks: Lead quality management and continuous improvement in a dynamic healthcare environment.
  • Company: Join Regeneron, a science-driven company making a difference in patients' lives.
  • Benefits: Enjoy competitive pay, bonuses, health benefits, and flexible work options.
  • Other info: Inclusive culture with opportunities for professional growth and mentorship.
  • Why this job: Make a real impact on quality standards in life-changing medicine development.
  • Qualifications: 10+ years in healthcare or pharma with strong quality management experience.

The predicted salary is between 70000 - 90000 Β£ per year.

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.

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.

Associate Director - Quality Standards and Continuous Improvement employer: BioSpace

Moderna is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the vibrant Harwell location. Employees benefit from competitive healthcare, generous paid time off, and a holistic approach to well-being, alongside opportunities for professional growth and development in cutting-edge mRNA science. Joining our team means making a meaningful impact on patients' lives while working with talented colleagues in a supportive environment.

BioSpace

Contact Details:

BioSpace Recruitment Team

We think you need these skills to ace Associate Director - Quality Standards and Continuous Improvement

Quality Management System Oversight
Quality Governance
Continuous Improvement
Issue Management Framework
Root Cause Analysis
CAPA Documentation Standards
Regulatory Agency Inspections