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- Tasks: Lead clinical quality oversight for studies, ensuring compliance with GCP standards and regulations.
- Company: Proclinical is a top life sciences recruiter connecting talent with leading global opportunities.
- Benefits: Enjoy a hybrid working model and the chance to work on impactful clinical trials.
- Other info: Travel required (10-25%); excellent communication skills are essential.
- Why this job: Join a dynamic team focused on quality assurance in life sciences, making a real difference.
- Qualifications: Advanced degree in life sciences or related field; experience in GCP Quality Assurance required.
The predicted salary is between 43200 - 72000 £ per year.
Proclinical is seeking a Senior Manager, R&D Quality Assurance (GCP) to provide clinical quality oversight for assigned clinical studies. In this role, you will ensure compliance with protocols, international and local regulations, and Good Clinical Practice (GCP) standards. You will lead inspection readiness efforts, support audit activities, and contribute to quality assurance initiatives. This position offers a hybrid working model based in Maidenhead, UK.
Responsibilities:
- Act as the QA Program Lead, overseeing compliance with protocols, company SOPs, GCP, and regulatory guidance.
- Develop and execute study audit plans, including investigator site audits, audit reports, and corrective/preventive action plans.
- Lead quality activities for late-phase clinical trials, focusing on risk management and endpoint de-risking.
- Address compliance issues, including sponsor, clinical site, and vendor non-compliance, through investigations and corrective actions.
- Provide guidance to junior QA staff and collaborate with internal teams and external partners.
- Drive inspection readiness efforts, including creating workstreams and preparing for regulatory inspections.
- Manage site-level inspections and oversee inspection-related CAPAs and quality events.
- Support vendor quality oversight, including vendor audits and CAPA reviews.
- Participate in process audits, process improvement initiatives, and updates to QA tools and SOPs.
- Stay updated on local and international GCP requirements and developments.
- Travel as required (approximately 10-25%).
Key Skills and Requirements:
- Background in life sciences, technology, pharmacy, or a related field; advanced degree preferred.
- Proven experience in GCP Quality Assurance and clinical trial oversight.
- Expertise in managing late-phase clinical trials and leading audits.
- Experience in inspection readiness and direct involvement in regulatory inspections.
- Strong knowledge of GCP regulations and industry guidance (e.g., FDA, EMA).
- Familiarity with various QA functions, including auditing, clinical operations, regulatory affairs, and data management.
- Excellent communication and collaboration skills.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click \’Apply\’ or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you\’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.proclinical.com/privacy-policy
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Senior Manager, R&D Quality Assurance (GCP) employer: Proclinical Group
Contact Detail:
Proclinical Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, R&D Quality Assurance (GCP)
✨Tip Number 1
Familiarise yourself with the latest GCP regulations and guidelines. This will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the R&D Quality Assurance space, especially those who have experience in late-phase clinical trials. Engaging with industry peers can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare for potential interview questions by reviewing common scenarios related to compliance issues and audit management. Being able to discuss your problem-solving approach will set you apart.
✨Tip Number 4
Showcase your leadership skills by discussing any experiences where you've guided junior staff or led teams in quality assurance initiatives. Highlighting these experiences can demonstrate your readiness for a senior role.
We think you need these skills to ace Senior Manager, R&D Quality Assurance (GCP)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Manager, R&D Quality Assurance (GCP) position. Tailor your application to highlight relevant experience in GCP compliance and clinical trial oversight.
Highlight Relevant Experience: In your CV and cover letter, emphasise your background in life sciences and any specific experience you have with late-phase clinical trials, audits, and regulatory inspections. Use concrete examples to demonstrate your expertise in GCP and quality assurance.
Craft a Strong Cover Letter: Write a compelling cover letter that not only outlines your qualifications but also conveys your passion for quality assurance in clinical research. Mention how your skills align with the company's goals and the specific challenges of the role.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in a quality assurance role.
How to prepare for a job interview at Proclinical Group
✨Showcase Your GCP Knowledge
Make sure to brush up on Good Clinical Practice (GCP) regulations and guidelines. Be prepared to discuss how you've applied these standards in your previous roles, especially in clinical trial oversight.
✨Demonstrate Leadership Experience
As a Senior Manager, you'll need to lead teams and initiatives. Share specific examples of how you've successfully managed audits or inspection readiness efforts in the past, highlighting your leadership skills.
✨Prepare for Compliance Scenarios
Expect questions about handling compliance issues. Think of real-life situations where you addressed non-compliance and what corrective actions you implemented. This will show your problem-solving abilities.
✨Emphasise Collaboration Skills
This role requires working with various teams and external partners. Be ready to discuss how you've effectively collaborated in cross-functional settings and how you can guide junior QA staff.