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- Tasks: Lead clinical quality oversight for studies and ensure compliance with GCP standards.
- Company: Proclinical, a top life sciences recruiter with a global reach.
- Benefits: Hybrid working model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with travel opportunities and excellent career advancement potential.
- Why this job: Make a real impact in clinical trials and drive quality assurance initiatives.
- Qualifications: Experience in GCP Quality Assurance and strong communication skills required.
The predicted salary is between 60000 - 80000 £ per year.
Proclinical is seeking a Senior Manager, R&D Quality Assurance (GCP) to provide clinical quality oversight for assigned clinical studies. In this role, you will ensure compliance with protocols, international and local regulations, and Good Clinical Practice (GCP) standards. You will lead inspection readiness efforts, support audit activities, and contribute to quality assurance initiatives. The position offers a hybrid working model based in Maidenhead, UK.
Responsibilities:
- Act as the QA Program Lead, overseeing compliance with protocols, company SOPs, GCP, and regulatory guidance.
- Develop and execute study audit plans, including investigator site audits, audit reports, and corrective/preventive action plans.
- Lead quality activities for late-phase clinical trials, focusing on risk management and endpoint de-risking.
- Address compliance issues, including sponsor, clinical site, and vendor non-compliance, through investigations and corrective actions.
- Provide guidance to junior QA staff and collaborate with internal teams and external partners.
- Drive inspection readiness efforts, including creating workstreams and preparing for regulatory inspections.
- Manage site-level inspections and oversee inspection-related CAPAs and quality events.
- Support vendor quality oversight, including vendor audits and CAPA reviews.
- Participate in process audits, process improvement initiatives, and updates to QA tools and SOPs.
- Stay updated on local and international GCP requirements and developments.
- Travel as required (approximately 10-25%).
Key Skills and Requirements:
- Background in life sciences, technology, pharmacy, or a related field; advanced degree preferred.
- Proven experience in GCP Quality Assurance and clinical trial oversight.
- Expertise in managing late-phase clinical trials and leading audits.
- Experience in inspection readiness and direct involvement in regulatory inspections.
- Strong knowledge of GCP regulations and industry guidance (e.g., FDA, EMA).
- Familiarity with various QA functions, including auditing, clinical operations, regulatory affairs, and data management.
- Excellent communication and collaboration skills.
Senior Manager, R&D Quality Assurance (GCP) in England employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, R&D Quality Assurance (GCP) in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the life sciences and QA fields. Attend industry events or webinars, and don’t be shy about asking for introductions. We all know someone who knows someone, so leverage that to get your foot in the door.
✨Tip Number 2
Prepare for interviews by brushing up on GCP regulations and recent developments. We recommend creating a cheat sheet of key points and questions you might face. This way, you’ll feel confident and ready to showcase your expertise when it counts!
✨Tip Number 3
Showcase your leadership skills! When discussing your experience, highlight how you've led teams or projects in quality assurance. We want to see how you can guide others and drive compliance efforts effectively.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who are ready to make an impact in the R&D Quality Assurance space.
We think you need these skills to ace Senior Manager, R&D Quality Assurance (GCP) in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Manager, R&D Quality Assurance role. Highlight your experience in GCP and clinical trial oversight, as well as any relevant audits you've led. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in clinical trials and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Achievements: When detailing your experience, focus on specific achievements rather than just responsibilities. Did you lead a successful audit or improve compliance rates? We want to know how you've made a difference in your previous roles!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and you'll be one step closer to joining our amazing team at StudySmarter. Don’t miss out!
How to prepare for a job interview at Proclinical Staffing
✨Know Your GCP Inside Out
Make sure you brush up on Good Clinical Practice (GCP) regulations and guidelines. Familiarise yourself with the latest updates and how they apply to clinical trials, especially late-phase studies. This will show your potential employer that you're not just knowledgeable but also proactive about staying current in the field.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to demonstrate your problem-solving skills in real-world situations. Think of examples from your past experiences where you've successfully managed compliance issues or led audits. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll be expected to lead teams and guide junior staff. Be ready to discuss your leadership style and provide examples of how you've mentored others or driven quality initiatives. Highlight any experience you have in managing cross-functional teams or collaborating with external partners.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the role and the company. Inquire about their current quality assurance initiatives or how they handle inspection readiness. This not only demonstrates your enthusiasm but also helps you gauge if the company aligns with your career goals.