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- Tasks: Support quality systems and ensure compliance in clinical studies.
- Company: Leading pharmaceutical company focused on quality and innovation.
- Benefits: Full-time role with hybrid work model and competitive salary.
- Why this job: Join a dynamic team making a real impact in clinical quality excellence.
- Qualifications: 8 years in pharma, strong GCP knowledge, and SOP writing experience.
- Other info: Opportunity for career growth in a collaborative environment.
The predicted salary is between 36000 - 60000 £ per year.
The Senior Process Quality Excellence Specialist (SPQES) will support the Head of Process Quality Excellence (HPQE) for GCSO in developing and maintaining its clinical quality systems and procedures, ensuring quality and compliance risks are appropriately identified and mitigated. Activities include all aspects of clinical studies managed by Global Clinical Sciences and Operations (GCSO) and require a focus on Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Pharmacovigilance (PV) regulations and guidance.
Responsibilities:
- Support the HPQE in GCSO quality and compliance infrastructure development; assist with creation/revision of appropriate quality and compliance policies, Standard Operating Procedures (SOPs), processes, and best practices as needed.
- Work in collaboration with Global Quality, Patient Safety, Regulatory Affairs strategic partners, and other stakeholders to ensure compliance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP, GLP, PV, and relevant local and international regulations to ensure inspection readiness.
- Lead and drive GCSO Inspection Readiness Activities across all GCSO functions, working closely with the relevant inspection team(s).
- Participate in Audit and Inspection planning with Global Quality.
- Represent or ensure GCSO representation including preparation during audits/inspections (on-site at UCB by internal and external parties).
- Support GCSO staff with audit/inspection responses where required.
Requirements:
- 8 years of pharmaceutical experience, preferably in a global Quality Assurance or Clinical Development setting.
- In-depth experience of GCP and GVP including hands-on experience in global GCP audits and/or inspections.
- 2 years of experience in SOP writing essential.
- Ability to work in a hybrid model, visiting the office about 2 times a week in Slough.
Employment Type: Full Time
Senior Process Quality Excellence Specialist in Slough employer: Next-Link
Contact Detail:
Next-Link Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Process Quality Excellence Specialist in Slough
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical and clinical development sectors. Use platforms like LinkedIn to connect with people who work at companies you're interested in, and don't be shy about asking for informational interviews.
✨Tip Number 2
Prepare for interviews by brushing up on GCP, GLP, and PV regulations. Make sure you can discuss how your experience aligns with the role of a Senior Process Quality Excellence Specialist. We want to hear how you’ve tackled compliance challenges in the past!
✨Tip Number 3
Showcase your audit and inspection experience! Be ready to share specific examples of how you've contributed to inspection readiness or led audit activities. This will demonstrate your hands-on expertise and make you stand out.
✨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 about their job search.
We think you need these skills to ace Senior Process Quality Excellence Specialist in Slough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Process Quality Excellence Specialist role. Highlight your experience with GCP, GLP, and any relevant compliance work. 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 excellence in clinical studies. Share specific examples of how you've contributed to compliance and quality systems in the past.
Showcase Your Teamwork Skills: Collaboration is key in this role. Make sure to mention any experiences where you worked closely with cross-functional teams or stakeholders. We love seeing how you can bring people together to achieve common goals!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining the StudySmarter team!
How to prepare for a job interview at Next-Link
✨Know Your GCP and GLP Inside Out
Make sure you brush up on Good Clinical Practice (GCP) and Good Laboratory Practices (GLP) before the interview. Be ready to discuss how you've applied these principles in your previous roles, especially in relation to compliance and quality systems.
✨Showcase Your SOP Writing Skills
Since SOP writing is essential for this role, prepare examples of SOPs you've created or revised. Highlight your process for developing these documents and how they contributed to compliance and quality improvements.
✨Demonstrate Inspection Readiness Experience
Be prepared to talk about your experience with audits and inspections. Share specific instances where you led inspection readiness activities and how you ensured compliance with regulations. This will show your proactive approach to quality assurance.
✨Collaborate and Communicate
This role requires collaboration with various stakeholders. Think of examples where you've successfully worked with cross-functional teams to achieve compliance goals. Emphasise your communication skills and how they helped in navigating complex regulatory environments.
