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For Companies At a Glance
- 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 a real 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 Staffing
Contact Detail:
Proclinical Staffing 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 neurology and biotechnology space on LinkedIn. A friendly message can go a long way in getting your foot in the door.
✨Tip Number 2
Prepare for those interviews by brushing up on your regulatory intelligence knowledge. We recommend creating a cheat sheet of key regulations and compliance standards to impress your interviewers.
✨Tip Number 3
Don’t just wait for job alerts—be proactive! Regularly check our website for new openings and apply directly. It shows initiative and can set you apart from other candidates.
✨Tip Number 4
Follow up after interviews! A quick thank-you email reiterating your interest in the role can keep you top of mind for hiring managers. Plus, it’s a nice touch that reflects your professionalism.
We think you need these skills to ace Senior Process Quality Excellence Specialist in Slough
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in regulatory intelligence and quality management. We want to see how your skills align with the role of Senior Process Quality Excellence Specialist, so don’t hold back!
Showcase Your Coordination Skills: Since this role involves a lot of collaboration with SMEs and cross-functional teams, be sure to include examples of your excellent coordination and communication skills. We love seeing how you’ve successfully managed projects or audits in the past!
Be Detail-Oriented: Attention to detail is key in this position. When writing your application, make sure to proofread for any errors and ensure that your experience reflects a strong focus on compliance and process improvement. We appreciate candidates who take pride in their work!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother application process. It’s the best way for us to receive your application and get you started on your journey with us at Proclinical!
How to prepare for a job interview at Proclinical Staffing
✨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.
