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- Tasks: Ensure compliance with regulations and maintain inspection readiness in a collaborative environment.
- Company: Join a global biopharmaceutical leader focused on innovative healthcare solutions.
- Benefits: Enjoy remote work options, competitive referral schemes, and a chance for career growth.
- Why this job: Be part of a dynamic team making a real impact in healthcare innovation.
- Qualifications: 4+ years in GCP Quality roles with experience in audits, inspections, and SOP writing.
- Other info: Open to all qualified candidates, promoting diversity and inclusion.
The predicted salary is between 48000 - 72000 £ per year.
Role Title: 2x Process Quality Specialist Location: Remote in the UK or Hybrid in Uxbridge
Contract Length: 12 Months with an high chance of extension/going permanent
Our client is a global biopharmaceutical company, specializing in the discovery and development of innovative medicines and solutions for severe diseases such as neurology and immunology. Joining this company means becoming part of a dynamic and forward-thinking organization committed to making a difference in healthcare. With its strong emphasis on innovation, collaboration, and patient impact, Our client offers a fulfilling career for those passionate about creating solutions that improve lives globally.
In this role you will work in collaboration with Clinical Development Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with ICH GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness. Minimum 4 years of experience in a GCP Quality Role
Experience with GCP audits & Inspections experience
Gap analysis experience & Experience writing SOPs
Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
SENIOR CLINICAL QA MANAGER employer: Planet Pharma
Contact Detail:
Planet Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land SENIOR CLINICAL QA MANAGER
✨Tip Number 1
Make sure to highlight your experience with GCP audits and inspections during any conversations or networking opportunities. This is a key requirement for the role, and demonstrating your expertise can set you apart from other candidates.
✨Tip Number 2
Familiarize yourself with the latest ICH GCP guidelines and relevant local regulations. Being well-versed in these areas will not only help you in interviews but also show your commitment to compliance and quality assurance.
✨Tip Number 3
Network with professionals in the biopharmaceutical industry, especially those who work in quality assurance roles. Engaging with others in the field can provide valuable insights and potentially lead to referrals.
✨Tip Number 4
Prepare to discuss specific examples of gap analysis and SOP writing from your previous roles. Concrete examples will demonstrate your hands-on experience and problem-solving skills, which are crucial for this position.
We think you need these skills to ace SENIOR CLINICAL QA MANAGER
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Senior Clinical QA Manager position. Understand the key responsibilities and required qualifications, especially focusing on GCP compliance and audit experience.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in GCP Quality roles, particularly any audits, inspections, and SOP writing. Use specific examples to demonstrate your expertise and how it aligns with the company's needs.
Tailor Your Application: Customize your application materials to reflect the values and mission of the biopharmaceutical company. Show your passion for innovation and patient impact, and explain how you can contribute to their goals.
Proofread and Submit: Before submitting your application, carefully proofread all documents for clarity and correctness. Ensure that your application is complete and accurately reflects your qualifications. Then, submit your application through our website.
How to prepare for a job interview at Planet Pharma
✨Understand the Regulatory Landscape
Make sure you have a solid grasp of ICH GCP, GLP, and PV regulations. Be prepared to discuss how your experience aligns with these standards and how you've ensured compliance in previous roles.
✨Showcase Your Audit Experience
Highlight your experience with GCP audits and inspections. Prepare specific examples of audits you've conducted or participated in, and be ready to discuss the outcomes and any improvements made as a result.
✨Demonstrate Your Problem-Solving Skills
Be ready to talk about your gap analysis experience. Discuss how you've identified compliance gaps in past roles and the strategies you implemented to address them effectively.
✨Prepare for Behavioral Questions
Expect questions that assess your collaboration skills, especially since this role involves working with various stakeholders. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
