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 £ 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
At Regeneron, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that fosters innovation and collaboration. Our commitment to employee growth is evident through comprehensive training programs and mentorship opportunities, ensuring that our team members thrive in their careers while contributing to life-changing advancements in healthcare. With competitive benefits and a hybrid work model across locations like Uxbridge, Dublin, Warren, and Armonk, we provide a supportive environment where you can make a meaningful impact on patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director - Quality Standards and Continuous Improvement
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We think you need these skills to ace Associate Director - Quality Standards and Continuous Improvement
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at BioSpace!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show BioSpace that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at BioSpace!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At BioSpace, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at BioSpace
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at BioSpace that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.