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- Tasks: Lead QA audits and ensure compliance in clinical trial technology systems.
- Company: Proclinical, a dynamic company focused on quality assurance in the biotech industry.
- Benefits: Fully remote work, flexible hours, and opportunities for travel within EMEA.
- Why this job: Make a real impact on clinical trials while working with a passionate team.
- Qualifications: Strong QA experience in CRO or pharmaceutical industries and leadership skills.
- Other info: Join a supportive environment with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
Are you a dedicated individual looking to put your QA expertise to work fully flexibly in a remote position? Proclinical is seeking an AD of Technology Quality Assurance to join a dynamic team focused on ensuring compliance and quality in clinical trial laboratory technology systems. This role involves overseeing audits, managing quality events, and collaborating with cross-functional teams to maintain and improve IT quality processes. The position offers a remote working opportunity with occasional travel within the EMEA region.
Responsibilities:
- Lead the planning, putting into place and reporting of Clinical Trial Laboratory Technology Systems audits, ensuring adherence to GxP standards, GAMP principles, and internal SOPs.
- Manage and lead a team of technology auditors and specialists.
- Evaluate audit findings, prepare reports, and ensure corrective and preventive actions are implemented effectively.
- Oversee and maintain electronic quality management systems (eQMS) and support the audit lifecycle.
- Review and approve investigations, root cause analyses, and corrective action plans, ensuring timely closure of quality events.
- Stay updated on regulatory developments and ensure compliance with industry best practices.
- Collaborate with IT, QA, and business functions to validate new systems and enhance existing IT quality processes.
- Provide guidance on regulatory controls, compliance status, and continuous process improvements.
- Lead and support quality assurance initiatives and projects.
- Train new Quality Assurance staff and provide compliance guidance to operational teams.
- Represent the Technology QA team during audits and client meetings as needed.
Key Skills and Requirements:
- Strong experience in Quality Assurance within the CRO, pharmaceutical, or biotechnology industries.
- Proficiency in auditing and compliance of computer systems in FDA-regulated environments, including clinical trials.
- Expertise in Computer Systems Validation (CSV) and software validation methodologies.
- Familiarity with lab instrumentation workflows and regulated equipment maintenance programs.
- Knowledge of GxP regulations, 21 CFR Part 11, GAMP guidelines, and data integrity requirements.
- Experience conducting internal and third-party audits and managing organizational responses.
- Strong leadership skills with experience in direct line management.
- Excellent understanding of clinical trial processes and quality subsystems.
Associate Director, Technology Qa in England employer: Proclinical
Contact Detail:
Proclinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Technology Qa in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in QA or related fields. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GxP standards and Computer Systems Validation. We recommend practising common interview questions and scenarios related to quality assurance to show off your expertise.
✨Tip Number 3
Don’t forget to showcase your leadership skills! When discussing your experience, highlight times when you’ve led teams or projects, especially in compliance and quality processes. This will make you stand out as a candidate.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our platform.
We think you need these skills to ace Associate Director, Technology Qa in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your QA expertise and experience in the CRO, pharmaceutical, or biotechnology industries. We want to see how your skills align with the role, so don’t be shy about showcasing relevant projects and achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how you can contribute to our dynamic team. We love seeing personality, so let your enthusiasm for the role come through.
Showcase Your Leadership Skills: Since this role involves managing a team, make sure to highlight your leadership experience. Share examples of how you've led teams, managed audits, or implemented quality processes. We’re looking for someone who can inspire and guide others!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Proclinical
✨Know Your GxP and GAMP Inside Out
Make sure you brush up on GxP standards and GAMP principles before the interview. Being able to discuss these in detail will show that you’re not just familiar with the regulations but can also apply them practically in your role.
✨Showcase Your Leadership Skills
Since this role involves managing a team, be prepared to share specific examples of how you've successfully led teams in the past. Highlight your experience in direct line management and how you’ve fostered collaboration among cross-functional teams.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific quality events or audit findings. Think through some scenarios where you had to implement corrective actions or manage compliance issues, and be ready to discuss your thought process and outcomes.
✨Stay Updated on Regulatory Developments
Demonstrate your commitment to continuous learning by discussing recent regulatory changes or industry best practices. This shows that you’re proactive and dedicated to maintaining high standards in quality assurance.
