At a Glance
- Tasks: Lead quality management for clinical trials and ensure compliance with regulations.
- Company: Join Regeneron, a leader in healthcare innovation and quality.
- Benefits: Competitive salary, flexible work arrangements, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on mentorship and continuous improvement.
- Why this job: Make a real impact in global health by ensuring quality in clinical development.
- Qualifications: 8+ years in healthcare/pharmaceuticals with expertise in quality management or clinical development.
The predicted salary is between 60000 - 80000 € per year.
The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. The GDQM (GCP) QML will engage with key stakeholders, build strategic partnerships working and liaising with study teams, relevant functions and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness.
For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position.
A day in the life may look like:
- Acting as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on any quality issues to ensure compliance and for the Quality Risk Assessment process.
- Ensuring and responsible for Risk-Based Quality Management (RBQM) initiatives and process improvements, in partnership with other functional areas.
- Responsible for the management of GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team.
- Providing day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending.
- Engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system.
- Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH-GCP.
This may be the right role for you if you have experience:
- Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience.
- Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP).
- Providing consultation, mentorship, training, and support in respect to compliance with applicable international regulations, practices, and guidelines.
- Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach) via the issue escalation process.
- Supporting the collection and reporting of data (e.g., metrics).
- Contributing to and supporting process improvement initiatives and workgroups, as assigned.
- Exemplifying a quality mindset and behaviours in all interactions with internal and external colleagues, serving as an ambassador for GDQ.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Senior Manager, GCP Quality Management - Uxbridge in London employer: Regeneron
Regeneron is an exceptional employer that fosters a collaborative and innovative work culture, particularly in Uxbridge, where the Senior Manager, GCP Quality Management role offers a balanced hybrid working model. Employees benefit from comprehensive professional development opportunities, a commitment to quality and compliance, and the chance to make a meaningful impact on global clinical trials, all while being part of a diverse and inclusive team dedicated to excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, GCP Quality Management - Uxbridge in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at Regeneron or have insights into GCP Quality Management. A friendly chat can open doors and give you insider info that could set you apart.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of Good Clinical Practice (GCP) and relevant regulations. We want you to showcase your expertise, so think about how your experience aligns with the role and be ready to discuss specific examples.
✨Tip Number 3
Don’t forget to ask questions during the interview! This shows your interest and helps you gauge if the company culture fits you. Think about what you want to know regarding their quality management processes and team dynamics.
✨Tip Number 4
Apply through our website for the best chance of getting noticed! We love seeing candidates who take the initiative to engage directly with us. Plus, it’s a great way to stay updated on any new opportunities that pop up.
We think you need these skills to ace Senior Manager, GCP Quality Management - Uxbridge in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Manager, GCP Quality Management role. Highlight your relevant experience in quality management and compliance, and don’t forget to showcase any leadership roles you've had. We want to see how you can bring your expertise to our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this position. Share specific examples of your past experiences that align with the job description. Remember, we love a good story that shows your passion for quality management.
Showcase Your Soft Skills:While technical skills are crucial, don’t forget to highlight your soft skills too! Communication, teamwork, and problem-solving are key in this role. We want to know how you’ve successfully collaborated with cross-functional teams in the past.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy and ensures your application goes directly to us. Plus, you’ll get to see all the other amazing opportunities we have at StudySmarter!
How to prepare for a job interview at Regeneron
✨Know Your GCP Inside Out
Make sure you brush up on Good Clinical Practice (GCP) guidelines and any recent updates. Being able to discuss these confidently will show that you're not just familiar with the basics, but that you’re also a Subject Matter Expert who can lead quality management initiatives.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams or projects in the past. Highlight your experience in mentoring and supporting cross-functional stakeholders, as this role requires strong leadership and collaboration skills.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific quality issues or compliance challenges. Think through potential scenarios related to risk-based quality management and be ready to discuss your thought process and actions.
✨Engage with the Interviewers
Don’t just answer questions; engage with your interviewers. Ask insightful questions about their current quality management processes and how you can contribute. This shows your genuine interest in the role and helps build rapport.
