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- Tasks: Lead audits and ensure quality in clinical trial technology systems.
- Company: Proclinical, a leading life sciences recruiter with a dynamic team.
- Benefits: Fully remote work, occasional travel, and opportunities for professional growth.
- Why this job: Make a real impact in the life sciences industry while working flexibly.
- Qualifications: Strong QA experience in CRO, pharma, or biotech; leadership skills required.
- Other info: Join a collaborative environment focused on compliance and quality assurance.
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 City of London employer: Proclinical Group
Contact Detail:
Proclinical Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Technology QA in City of London
✨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 want you to be ready to showcase your expertise and how it aligns with the role of Associate Director in Technology QA.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can keep you fresh in the interviewer's mind and show your enthusiasm for the position. Plus, it’s a great chance to reiterate why you’re the perfect fit.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to engage directly with us. Let’s get you that dream job!
We think you need these skills to ace Associate Director, Technology QA in City of London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director, Technology QA role. Highlight your relevant experience in Quality Assurance, especially in the CRO or pharmaceutical industries. We want to see how your skills align with the job description!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about QA and how your expertise can benefit our team. Keep it concise but impactful – we love a good story that showcases your journey.
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 in the past and the positive outcomes that resulted. 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 easiest way for us to receive your application and ensures you don’t miss any important updates. Plus, it shows you’re keen on joining our dynamic team!
How to prepare for a job interview at Proclinical Group
✨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 them, but that you can apply them in real-world scenarios.
✨Showcase Your Leadership Skills
Since this role involves managing a team, be prepared to share examples of your leadership experience. Think about times when you led audits or quality assurance initiatives and how you motivated your team to achieve compliance.
✨Prepare for Technical Questions
Expect questions about Computer Systems Validation (CSV) and software validation methodologies. Brush up on your knowledge of lab instrumentation workflows and be ready to explain how you’ve ensured data integrity in past roles.
✨Demonstrate Your Collaborative Spirit
This position requires collaboration with various teams. Be ready to discuss how you’ve worked with IT, QA, and other business functions in the past to enhance quality processes. Highlight any successful projects where teamwork made a difference.
