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- Tasks: Coordinate regulatory intelligence and manage audit processes for clinical safety operations.
- Company: Global pharmaceutical company with a focus on quality excellence.
- Benefits: Competitive hourly rates and the opportunity to work onsite in a dynamic environment.
- Why this job: Join a growing team and make a significant impact in global clinical studies.
- Qualifications: Regulatory intelligence experience and a background in QA or Clinical Operations preferred.
- Other info: Full-time role with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
A global pharmaceutical company is looking to hire a Senior Process Quality Excellence Specialist on an initial 12 month contract. Working on global study specific activities within a growing team, you will bring comprehensive Regulatory Intelligence experience and will successfully manage the RIN requirements for Global Clinical Safety Operations.
Responsibilities:
- Become the Regulatory Intelligence coordinator to work with the relevant SMEs for regulatory/guidance requirements to controlled documents.
- Review regulations and identify which SMEs should be assigned based on the topic.
- Act as a point of contact to confirm that CROs have assessed regulatory and country regulations that may impact their SOPs and clinical studies.
- Act as Audit Host - work with the Auditing team to host and coordinate with relevant SMEs and functions on any internal Quality Audit.
- Act as a point of contact and co-ordinator with the auditing team.
- During the audit, assist the assigned SMEs in responding to queries by the auditees.
- Post-audit, work with the SMEs on responses to findings, CAPAs, etc., until the audit is closed.
Additional information:
- Regulatory Intelligence experience required
- QA or Clinical Operations background preferred
- GCP experience necessary
- Willingness to work onsite in Slough 2 days per week
- Full-time role
- Competitive hourly rates
Senior Process Quality Excellence Specialist in London employer: Warman O'Brien
Contact Detail:
Warman O'Brien Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Process Quality Excellence Specialist in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in regulatory intelligence or quality assurance. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP and regulatory requirements. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during the interview.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression and show your enthusiasm for the role. Plus, it keeps you on their radar as they make their decision.
✨Tip Number 4
Apply through our website for the best chance at landing that Senior Process Quality Excellence Specialist role. We’re always looking for passionate candidates, and applying directly can help us see your application faster!
We think you need these skills to ace Senior Process Quality Excellence Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Process Quality Excellence Specialist role. Highlight your Regulatory Intelligence experience and any relevant QA or Clinical Operations background. We want to see how your skills match 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 the perfect fit for this role. Mention specific experiences that relate to the responsibilities listed in the job description, and don’t forget to show your enthusiasm for joining our team.
Showcase Your GCP Knowledge: Since GCP experience is necessary for this role, make sure to highlight any relevant projects or roles where you've applied GCP principles. We want to know how you can contribute to our Global Clinical Safety Operations!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Warman O'Brien
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory intelligence and GCP guidelines. Familiarise yourself with the latest regulations that could impact clinical studies, as this will show your potential employer that you're proactive and well-informed.
✨Showcase Your Coordination Skills
Since the role involves acting as a point of contact and coordinator, prepare examples from your past experiences where you've successfully managed multiple stakeholders or projects. Highlight how you facilitated communication between teams and ensured everyone was on the same page.
✨Prepare for Audit Scenarios
Think about your experience with audits and be ready to discuss specific situations where you acted as an audit host or supported SMEs during audits. This will demonstrate your hands-on experience and ability to handle pressure during critical evaluations.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company and the role. Inquire about their current challenges in regulatory compliance or how they measure success in the Quality Excellence team. This will help you stand out as a candidate who is genuinely interested in contributing to their goals.