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- Tasks: Lead the audit journey and ensure compliance in the biotech and neurology sectors.
- Company: Proclinical, a top life sciences recruiter with a global reach.
- Benefits: Competitive salary, career growth, and a chance to make an impact.
- Why this job: Be at the forefront of regulatory excellence and quality management.
- Qualifications: Experience in regulatory intelligence and strong communication skills required.
- Other info: Join a dynamic team focused on innovation and compliance.
The predicted salary is between 36000 - 60000 £ per year.
Own the audit journey—from preparation to closure with excellence. Proclinical is seeking a Senior Process Quality Excellence Specialist to support regulatory intelligence and quality excellence initiatives within the neurology and biotechnology space. This role focuses on managing regulatory guidance requirements, coordinating with subject matter experts (SMEs), and ensuring compliance with controlled documents. Additionally, you will act as a key point of contact for audits, working closely with auditing teams and SMEs to facilitate smooth processes and address findings.
Responsibilities
- Serve as the RIN (Regulatory Intelligence Network) coordinator, managing regulatory guidance requirements for GCSO.
- Collaborate with SMEs to review regulations and assign responsibilities based on specific topics.
- Act as a liaison to confirm that CROs have assessed regulatory and country-specific regulations impacting their SOPs and studies.
- Host and coordinate internal quality audits in collaboration with the auditing team and relevant SMEs.
- Assist SMEs during audits by responding to queries and facilitating communication with auditees.
- Support post-audit activities, including addressing findings, developing CAPAs, and ensuring audit closure.
Key Skills and Requirements
- Strong experience in regulatory intelligence and quality management.
- Ability to review and interpret regulations and assign responsibilities effectively.
- Excellent coordination and communication skills to work with cross-functional teams and SMEs.
- Familiarity with audit processes, including hosting, query resolution, and post-audit follow-up.
- Detail-oriented with a focus on compliance and process improvement.
Senior Process Quality Excellence Specialist in Slough employer: Proclinical Group
Contact Detail:
Proclinical Group 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 people in the industry, especially those who work in regulatory intelligence and quality management. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of audit processes and regulatory requirements. We recommend practising common interview questions with a friend or using mock interview tools to boost your confidence.
✨Tip Number 3
Showcase your experience! When you get the chance to speak with hiring managers, highlight your past successes in managing audits and collaborating with SMEs. Use specific examples to demonstrate your skills and achievements.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for talented individuals like you to join our team!
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 in regulatory intelligence and quality management, and don’t forget to showcase your coordination skills with SMEs.
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 managing audits and compliance, and show us your passion for the neurology and biotechnology space.
Showcase Your Attention to Detail: Since this role requires a detail-oriented approach, make sure your application is free from typos and errors. A polished application reflects your commitment to quality and compliance, which is key for this position.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It’s the best way for us to receive your application and ensures you don’t miss any important updates about your application status!
How to prepare for a job interview at Proclinical Group
✨Know Your Regulations
Make sure you brush up on the latest regulations relevant to the neurology and biotechnology sectors. Being able to discuss specific regulatory guidance during your interview will show that you're not just familiar with the field, but that you’re proactive about staying informed.
✨Showcase Your Coordination Skills
Prepare examples of how you've successfully coordinated with SMEs or cross-functional teams in the past. Highlighting your ability to manage multiple stakeholders and ensure smooth communication will demonstrate your fit for the role.
✨Audit Process Familiarity
Since this role involves hosting internal quality audits, be ready to discuss your experience with audit processes. Share specific instances where you facilitated audits or addressed findings, as this will illustrate your hands-on knowledge and problem-solving skills.
✨Detail Orientation is Key
Emphasise your attention to detail by preparing to discuss how you've improved compliance and processes in previous roles. Bring concrete examples of CAPAs you've developed or how you've ensured audit closure, as this will resonate well with the interviewers.
