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- Tasks: Coordinate quality audits and manage regulatory intelligence for a global pharmaceutical company.
- Company: Join a leading pharmaceutical firm focused on innovative medicines for severe diseases.
- Benefits: Competitive pay, flexible work schedule, and opportunities for professional growth.
- Why this job: Make a real impact in clinical safety operations while developing your skills in a dynamic environment.
- Qualifications: Experience in regulatory compliance and strong organisational skills are essential.
- Other info: 12-month contract with potential for career advancement in the pharmaceutical industry.
The predicted salary is between 40 - 48 £ per hour.
Location: Berkshire (2 days in the office - Tuesday/Thursday)
Contract: 12-month contract
Rate: Up to £47.92 using an umbrella company
CK Group are recruiting on behalf of a global pharmaceutical company specialising in the discovery, development, and commercialisation of medicines for severe diseases within neurology and immunology.
This is a 12-month contract opportunity for a Process Quality Excellence Specialist, supporting the Global Clinical Safety Operations (GCSO) function.
The Role
This is a hands-on, coordination-focused quality role, suited to someone comfortable working across audits, regulatory intelligence, and cross-functional stakeholders. The successful candidate will act as a key point of contact for both regulatory intelligence notifications (RIN) and internal quality audits.
Key Responsibilities
- Regulatory Intelligence & RIN Coordination
- Act as the RIN Coordinator for GCSO, managing Regulatory Intelligence Notifications and associated actions
- Review new and updated regulations and guidance, assessing impact on controlled documents
- Identify and assign appropriate Subject Matter Experts (SMEs) based on regulatory topics
- Track actions and timelines, ensuring follow-up and completion
- Act as a point of contact to confirm CRO assessment of regulatory and country-specific requirements impacting SOPs and clinical studies
- Act as Audit Host for internal quality audits
- Coordinate with the internal Auditing team and relevant SMEs and functions
- Prepare for audits, manage documentation requests, and track timelines
- Support SMEs during audits by coordinating responses to auditor queries
- Manage post-audit activities including findings, CAPAs, and follow-up actions through to audit closure
Your Background
- Experience in Regulatory Intelligence, RIN coordination, or regulatory compliance within a GxP environment
- Prior involvement in quality audits, either as an audit host or audit support function
- Strong understanding of GCP and clinical research regulatory requirements
- Excellent organisational, coordination, and communication skills
- Ability to work across multiple stakeholders and manage timelines effectively
- QA background welcomed but not essential
Please send your CV and cover letter in English. It is essential that applicants hold entitlement to work in the UK. Please quote job reference in all correspondence #J-18808-Ljbffr
Process Quality Excellence Specialist employer: CK Group- Science, Clinical and Technical
Contact Detail:
CK Group- Science, Clinical and Technical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Process Quality Excellence Specialist
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work in regulatory intelligence or quality audits. 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 clinical research regulations. We want you to be ready to discuss how your experience aligns with the role of Process Quality Excellence Specialist.
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've managed timelines and coordinated with multiple stakeholders. This will highlight your fit for the coordination-focused nature of the role.
✨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 take that extra step to connect with us directly.
We think you need these skills to ace Process Quality Excellence Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Process Quality Excellence Specialist role. Highlight your experience in regulatory intelligence and quality audits, as these are key aspects of the job. 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 this role and how your skills can contribute to our team. Keep it concise but impactful – we love a good story that connects your experience to our mission.
Showcase Your Organisational Skills: Since this role involves managing timelines and coordinating with various stakeholders, make sure to highlight your organisational skills in both your CV and cover letter. We want to know how you keep everything on track and ensure nothing falls through the cracks!
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 gives you a chance to explore more about StudySmarter and what we stand for!
How to prepare for a job interview at CK Group- Science, Clinical and Technical
✨Know Your Regulations
Familiarise yourself with the latest regulations and guidance related to GCP and clinical research. Being able to discuss how these impact controlled documents will show your expertise and readiness for the role.
✨Showcase Your Coordination Skills
Prepare examples that highlight your organisational and coordination abilities. Think of specific instances where you managed timelines or coordinated with multiple stakeholders, as this is crucial for the Process Quality Excellence Specialist position.
✨Audit Experience Matters
If you've been involved in quality audits, be ready to share your experiences. Discuss your role, how you prepared for audits, and how you managed post-audit activities. This will demonstrate your hands-on experience in a relevant area.
✨Engage with Questions
Prepare thoughtful questions about the company's approach to regulatory intelligence and audit processes. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.