At a Glance
- Tasks: Implement and adapt the Global Quality Management Plan to enhance compliance and quality.
- Company: Join a leading clinical research organisation focused on quality and innovation.
- Benefits: Hybrid working model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with potential for travel and collaboration with diverse teams.
- Why this job: Make a real impact in clinical research while ensuring high-quality standards.
- Qualifications: Bachelor’s degree and 4 years of clinical research experience required.
The predicted salary is between 50000 - 65000 £ 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
As a Senior Quality Specialist at our Moorgate, London office, you will thrive in a dynamic and supportive work environment that prioritises quality and compliance. We offer a hybrid working model that promotes work-life balance, alongside opportunities for professional growth through training and collaboration with experienced teams. Join us to make a meaningful impact in clinical research while enjoying the vibrant culture of London.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Quality Specialist in Reading
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like IQVIA looking for candidates who are engaged and informed.
We think you need these skills to ace Sr Quality Specialist in Reading
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at IQVIA. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at IQVIA
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with IQVIA’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!