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, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with opportunities for training and collaboration 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.
- Perform risk identification and assessment through data review and quality control processes.
- Support risk mitigation and CAPA planning.
- Provide 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.
Sr Quality Specialist employer: IQVIA
At IQVIA, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the heart of London. 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 team dedicated to improving patient outcomes and making a meaningful impact in the healthcare industry.
StudySmarter Expert Advice🤫
We think this is how you could land Sr Quality Specialist
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the hunt for a Sr Quality Specialist role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your GCP knowledge and quality management practices. We recommend doing mock interviews with friends or using online platforms to get comfortable discussing your experience and how it aligns with the role.
✨Tip Number 3
Showcase your expertise! When you get the chance to meet potential employers, whether at networking events or interviews, be ready to discuss specific examples of how you've improved quality and compliance in past roles. This will set you apart from the competition.
✨Tip Number 4
Don't forget to apply through our website! We’ve got loads of opportunities that might just be the perfect fit for you. Plus, applying directly shows your enthusiasm and commitment to joining our team.
We think you need these skills to ace Sr Quality Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that align with the Sr Quality Specialist role. Highlight your clinical research background, especially any monitoring or quality management experience, to catch our eye!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management in clinical research and how your experience can contribute to our team. Keep it engaging and relevant!
Showcase Your Achievements:Don’t just list your responsibilities; showcase your achievements! Use metrics or examples to demonstrate how you've improved compliance or contributed to quality initiatives in your previous roles.
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, so we can review it promptly!
How to prepare for a job interview at IQVIA
✨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 specific examples from your past experience where you've implemented quality management strategies or dealt with CAPAs.
✨Showcase Your Collaboration Skills
This role involves working closely with various business lines and stakeholders. Prepare to share instances where you've successfully collaborated on quality improvement initiatives or resolved compliance issues. Highlight your ability to communicate effectively across teams.
✨Be Ready for Risk Assessment Questions
Expect questions about risk identification and mitigation. Think of scenarios where you’ve performed risk assessments and how you approached quality control processes. Being able to articulate your thought process will impress the interviewers.
✨Prepare for Training Discussions
Since delivering training is part of the job, be prepared to talk about any training sessions you've conducted. Share your approach to knowledge sharing and how you ensure that teams understand quality standards and compliance requirements.
