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- Tasks: Coordinate audits and manage regulatory updates to ensure clinical quality systems are inspection-ready.
- Company: Join a global biopharmaceutical leader dedicated to innovative medicines and patient impact.
- Benefits: Competitive salary, flexible working, and opportunities for professional growth.
- Why this job: Make a real difference in clinical quality while working with top industry experts.
- Qualifications: 3-5 years in Clinical Quality with strong GCP knowledge and audit experience.
- Other info: Dynamic hybrid work environment with a focus on collaboration and compliance.
The predicted salary is between 36000 - 60000 £ per year.
This is a dual-focused clinical quality role combining Audit Hosting and Regulatory Intelligence (RIN) coordination within a global clinical sciences and operations environment. The role acts as a central point of contact between Quality Assurance, internal SMEs and external partners to ensure clinical quality systems remain inspection-ready and aligned with evolving GCP regulatory requirements. You will coordinate internal audits, support audit follow-up activities including CAPAs and manage regulatory intelligence updates impacting controlled documents across the organisation.
You will be joining a global, science-driven biopharmaceutical organisation committed to advancing innovative medicines that make a meaningful difference to patients’ lives. With a strong focus on quality, compliance and collaboration, the company operates across international markets and partners closely with CROs and regulatory authorities to deliver high-quality clinical research in line with global standards.
Key Responsibilities- Act as Audit Host for internal quality audits, serving as the primary coordinator between the auditing team and relevant internal SMEs.
- Prepare for audits by coordinating document requests, scheduling meetings and ensuring stakeholder readiness.
- Support SMEs during audits by facilitating responses to auditor queries.
- Coordinate post-audit activities, including responses to findings, CAPAs and follow-up actions through to audit closure.
- Act as Regulatory Intelligence (RIN) Coordinator for the Global Clinical Sciences and Operations group.
- Monitor changes in GCP regulations, guidance and country-specific requirements impacting clinical operations.
- Perform high-level gap assessments to determine impact on existing SOPs and controlled documents.
- Identify and assign appropriate SMEs to review and update documentation based on regulatory changes.
- Coordinate document updates, track timelines and actively chase stakeholders to ensure on-time completion.
- Act as a point of contact to confirm CROs have assessed regulatory and country requirements that may impact their SOPs and company-sponsored studies.
- 3–5 years’ experience within Clinical Quality in a pharma or CRO environment.
- Strong GCP background with hands-on experience in GCP clinical trials, audits or inspections.
- Experience supporting audits, including document provision and CAPA management.
- Clear understanding of quality systems within clinical development (GCP only – GMP/GLP experience not suitable).
- Experience with Regulatory Intelligence, regulatory surveillance or gap analysis is highly desirable.
- Alternatively, experience in Regulatory Intelligence with some exposure to GCP audits will be considered.
- Strong coordination, stakeholder management and follow-up skills.
- Confident working with SMEs to interpret regulations and translate requirements into document updates.
- Comfortable working in a hybrid environment and managing multiple priorities.
Process Quality Excellence Specialist in Reading employer: Planet Pharma
Contact Detail:
Planet Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Process Quality Excellence Specialist in Reading
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical quality field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your GCP knowledge and audit experiences. We recommend practising common interview questions related to quality assurance and regulatory intelligence to show you’re ready to hit the ground running.
✨Tip Number 3
Don’t forget to showcase your coordination and stakeholder management skills during interviews. We want to see how you’ve successfully managed multiple priorities in past roles, so have some examples ready!
✨Tip Number 4
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 Process Quality Excellence Specialist in Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV speaks directly to the role of Process Quality Excellence Specialist. Highlight your experience in clinical quality, audits, and regulatory intelligence. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality in clinical operations and how you can contribute to our mission. Keep it engaging and relevant to the job description.
Showcase Your Skills: Don’t just list your skills; demonstrate them! Use specific examples from your past experiences that showcase your coordination, stakeholder management, and audit support skills. We love seeing real-life applications of your expertise.
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 don’t miss any important updates from us!
How to prepare for a job interview at Planet Pharma
✨Know Your GCP Inside Out
Make sure you brush up on your Good Clinical Practice (GCP) knowledge before the interview. Be prepared to discuss specific regulations and how they impact clinical operations. This will show that you’re not just familiar with the concepts but can also apply them in real-world scenarios.
✨Showcase Your Audit Experience
Since the role involves acting as an Audit Host, be ready to share your past experiences with audits. Talk about how you coordinated document requests and supported SMEs during audits. Use specific examples to highlight your problem-solving skills and your ability to manage follow-up actions effectively.
✨Demonstrate Stakeholder Management Skills
This position requires strong coordination and stakeholder management skills. Prepare to discuss how you've successfully worked with various stakeholders in the past. Think of examples where you facilitated communication between teams or ensured timely completion of tasks, especially in a hybrid work environment.
✨Stay Updated on Regulatory Changes
As a Regulatory Intelligence Coordinator, it’s crucial to stay informed about changes in GCP regulations. Before your interview, research recent updates and be ready to discuss how these might affect clinical quality systems. This shows your proactive approach and commitment to maintaining compliance.
