At a Glance
- Tasks: Implement and adapt the Global Quality Management Plan to enhance compliance and quality.
- Company: Join IQVIA, a leader in clinical research and healthcare intelligence.
- Benefits: Enjoy a hybrid working model with competitive salary and professional growth opportunities.
- Other info: Dynamic role with opportunities for training and development in a supportive environment.
- Why this job: Make a real impact on patient outcomes while working with innovative medical treatments.
- Qualifications: Bachelor’s degree and 4 years of clinical research experience required.
The predicted salary is between 45000 - 55000 £ per year.
This role is assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the Line Manager (LM). The purpose of this role is to implement and adapt the Global Quality Management Plan in alignment with the specific needs of the assigned scope.
The CCQM supports business line staff in improving compliance with International Conference on Harmonisation (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, Standard Operating Procedures (SOPs), and Key Performance Indicators (KPIs). The role also contributes to the development and implementation of quality improvement initiatives and provides guidance on quality control, risk assessment, risk management, and corrective and preventive actions (CAPA).
Key Responsibilities
- Implement and execute the Global Quality Management Plan within the assigned scope, including:
- Planning and conducting quality management activities
- Performing risk identification and assessment through data review and quality control processes
- Supporting risk mitigation and CAPA planning
- Providing guidance to improve quality and operational effectiveness
- Collaborate closely with business lines and key stakeholders to ensure strong focus on quality in project delivery
- Provide expert advice and support on GCP compliance to assigned teams and stakeholders
- Support the management of non-compliance and quality issues in accordance with SOPs
- Develop, track, follow up, and ensure timely closure of CAPAs
- Identify and escalate serious quality issues in a timely manner
- Inform relevant business lines and Quality Assurance (QA) teams of quality issues per SOP requirements
- Partner with QA and business teams in cases of suspected misconduct as required
- Support audit and regulatory inspection readiness and participate as agreed
- Conduct quality control visits as required (primarily for unblinded studies where applicable)
- Prepare periodic reports on quality metrics, risks, and continuous quality improvement initiatives
- Deliver training and knowledge-sharing sessions to local teams, as applicable
- Perform additional tasks as assigned by the Line Manager
Qualifications & Experience
- Bachelor’s degree (required)
- Minimum 4 years of clinical research experience, including monitoring experience (e.g., CRA background)
- Experience in quality management or quality oversight is an advantage
- Experience participating in audits and regulatory inspections
- Experience delivering or contributing to training activities (primarily internal teams)
Working Model & Additional Information
- Hybrid working model: office-based and home-based
- Expected presence in the office approximately 2-3 days per week
- Office location: Moorgate, London
- Some travel to site may be required for quality control visits depending on study allocation
Please note this role is not eligible for UK Visa sponsorship.
Sr Quality Specialist in Reading employer: IQVIA LLC
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the heart of Reading, Berkshire. Our commitment to employee growth is evident through comprehensive training programmes and opportunities for career advancement, all while maintaining a flexible hybrid working model that promotes work-life balance. Join us to be part of a leading global provider in clinical research services, where your contributions directly impact patient outcomes and the future of healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Quality Specialist in Reading
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those already working at companies you're eyeing. A friendly chat can open doors and give you insider info on what they're really looking for.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to quality management. We recommend role-playing with a friend or using online resources to boost your confidence and refine your answers.
✨Tip Number 3
Showcase your expertise! Bring examples of your past work, especially any quality improvement initiatives you've led. This will help you stand out and demonstrate your hands-on experience in the field.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace Sr Quality Specialist in Reading
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Sr Quality Specialist role. Highlight your clinical research experience and any quality management skills you have. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management and how your experience can contribute to our team. Keep it engaging and relevant to the job description.
Showcase Your Achievements:When detailing your experience, focus on specific achievements that demonstrate your ability to improve quality and compliance. Numbers and examples speak volumes, so don’t hold back!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes straight to us. Let’s make this happen!
How to prepare for a job interview at IQVIA LLC
✨Know Your Quality Management Stuff
Make sure you brush up on the Global Quality Management Plan and how it aligns with ICH and GCP. Be ready to discuss your experience in quality management and how you've implemented similar plans in past roles.
✨Showcase Your Clinical Research Experience
With a minimum of 4 years in clinical research, you’ll want to highlight specific projects where you’ve monitored compliance or managed quality issues. Prepare examples that demonstrate your ability to handle audits and inspections.
✨Prepare for CAPA Discussions
Since CAPA is a key part of the role, think about times you've identified risks and implemented corrective actions. Be ready to explain your thought process and the outcomes of those actions during the interview.
✨Engage with Stakeholders
Collaboration is crucial, so come prepared with examples of how you've worked with different teams to improve quality. Think about how you can convey your ability to communicate effectively and build relationships with stakeholders.
