At a Glance
- Tasks: Lead risk-based audit strategies and ensure compliance across global development projects.
- Company: Join Regeneron, a science-driven company making a difference in patients' lives.
- Benefits: Competitive salary, bonuses, health benefits, and remote work options.
- Other info: Inclusive culture with excellent career growth opportunities and 10-20% travel.
- Why this job: Make a meaningful impact in a fast-growing organisation focused on life-changing medicines.
- Qualifications: 8+ years of industry experience and strong GCP audit knowledge required.
The predicted salary is between 60000 - 80000 £ per year.
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Audit Strategy, Global Development to join our Global Development Quality Assurance (GDQA), supporting our Global Development organization in a remote work mode.
In this role, you will lead risk-based audit strategy programs and oversee compliance across therapeutic areas, studies, and audit activities while collaborating with Global Development teams, auditors, and cross-functional stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Discover your role:
- Lead risk-based audit planning across therapeutic areas and studies
- Drive strategic audit programs using risk indicators from study teams
- Ensure audits align with approved programs and scheduled timelines
- Manage audit outcomes to identify trends and communicate risks
- Represent quality assurance on complex cross-functional initiatives
- Deliver reports and metrics to Global Development leadership
- Collaborate effectively with stakeholders across global functions
- Navigate ambiguity while prioritising multiple complex activities
This role requires:
- Bachelor’s degree with 8+ years of relevant industry experience
- 5+ years of GCP audit strategy or audit experience
- Knowledge of FDA, EU, and ICH GCP regulations and guidance
- Experience supporting or participating in regulatory inspections
- Strong project management and stakeholder management capabilities
- Excellent written and verbal communication skills with senior audiences
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, colour, 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.
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, health and wellness programs, fitness centres, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
Senior Manager QA Auditor GCP Strategy employer: Regeneron Pharmaceuticals
At Regeneron, we pride ourselves on fostering a collaborative and inclusive work culture that empowers our employees to make a meaningful impact in the field of life-changing medicine. As a Senior Manager in GCP Audit Strategy, you will benefit from a competitive rewards package, opportunities for professional growth, and the flexibility of remote work in the UK or Ireland, all while contributing to innovative projects that improve patient outcomes globally.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager QA Auditor GCP Strategy
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Regeneron Pharmaceuticals. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Regeneron Pharmaceuticals.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Regeneron Pharmaceuticals. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Regeneron Pharmaceuticals is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Manager QA Auditor GCP Strategy
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 Regeneron Pharmaceuticals!
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 Regeneron Pharmaceuticals 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 Regeneron Pharmaceuticals!
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 Regeneron Pharmaceuticals, 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 Regeneron Pharmaceuticals
✨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 Regeneron Pharmaceuticals that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
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
Take some time to familiarise yourself with Regeneron Pharmaceuticals’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
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.
