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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 team.
- Why this job: Join a growing team and make a real impact in global clinical safety.
- Qualifications: Regulatory intelligence experience and a background in QA or Clinical Operations.
- Other info: Full-time role with a collaborative environment and career growth potential.
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 Reading 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 Reading
✨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 list of common interview questions related to quality excellence and practicing your responses. Confidence is key!
✨Tip Number 3
Showcase your expertise! During interviews, be ready to discuss specific examples from your past experiences that highlight your skills in managing regulatory requirements and audits. Real-life stories make you memorable.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our platform.
We think you need these skills to ace Senior Process Quality Excellence Specialist in Reading
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.
✨Prepare for Audit Scenarios
Since you'll be acting as an Audit Host, think about common audit scenarios and how you would handle them. Prepare examples from your past experiences where you've successfully managed audits or quality checks, as this will demonstrate your capability in this area.
✨Connect with SMEs
Understand the importance of Subject Matter Experts (SMEs) in your role. Be ready to discuss how you would identify and collaborate with the right SMEs for various regulatory topics. This shows that you can effectively coordinate and communicate within a team.
✨Show Your Team Spirit
This role involves working closely with a growing team, so highlight your teamwork skills. Share examples of how you've worked collaboratively in previous roles, especially in QA or Clinical Operations, to illustrate that you're a great fit for their team culture.