Senior Clinical Quality Assurance Manager
Senior Clinical Quality Assurance Manager

Senior Clinical Quality Assurance Manager

Full-Time 43200 - 72000 £ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Lead quality assurance for clinical services, ensuring compliance with regulations and improving patient outcomes.
  • Company: Join WEP Clinical, a mission-driven organisation transforming lives through innovative clinical research solutions.
  • Benefits: Enjoy private healthcare, generous leave, pension options, and a supportive work environment.
  • Why this job: Be part of a dynamic team that values innovation, collaboration, and making a real difference in healthcare.
  • Qualifications: Bachelor’s degree and 7+ years in clinical research with a focus on quality assurance required.
  • Other info: WEP Clinical promotes wellness, growth, and diversity, fostering an inclusive workplace for all.

The predicted salary is between 43200 - 72000 £ per year.

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives:

The Senior Clinical Quality Assurance Manager at WEP Clinical oversees the maintenance and compliance of the Quality Management System, ensuring adherence to quality principles and Good Clinical Practice (GCP) regulatory requirements. This role supports key stakeholders across global clinical operations, including clinical trial management and the patient-enabling solutions group, which encompasses home health solutions, virtual clinical trials, patient concierge services, and patient recruitment. Additionally, the Senior Clinical Quality Assurance Manager is responsible for developing, implementing, and maintaining quality assurance standards and processes to uphold the safety, efficacy, and ethical conduct of clinical trials in compliance with GCP.

The Ideal Candidate:

  • Decisive and strategic leader
  • Adaptable and solution-oriented
  • Detail Oriented and analytical
  • Strong interpersonal skills

What You'll Do:

  • Develop, implement, and maintain a comprehensive quality assurance framework for clinical services, ensuring compliance with GCP, FDA, EMA, and internal standards
  • Manage quality records and processes, including deviations, change controls, CAPAs, complaints, and other quality incidents
  • Conduct risk assessments to identify and mitigate potential quality risks in nursing and clinical services
  • Perform audits and inspections to assess compliance, identify non-conformances, and implement corrective actions
  • Host external client and regulatory inspections, coordinating audits and responses
  • Monitor, develop, and deliver training on quality assurance principles, regulatory requirements, and SOPs
  • Oversee external vendors to ensure compliance with quality standards and regulatory requirements
  • Ensure compliance with regulatory requirements, including GCP, data privacy laws (e.g., GDPR), and local regulations
  • Identify and implement process improvements to enhance the quality and efficiency of clinical services and home health solutions
  • Serve as the key quality contact for projects, supporting setup and liaising with clients as needed

What You'll Need:

  • Bachelor’s degree or higher, preferably in pharmaceutical sciences, life sciences, or nursing
  • 7+ years of experience in clinical research with a focus on quality assurance and/or clinical services
  • In-depth knowledge of clinical trial methodologies, regulatory requirements, and GCP guidelines
  • Experience with decentralized clinical trials and remote patient monitoring is a plus
  • Demonstrated expertise in developing and implementing quality assurance systems, change management, and processes

What We Offer:

  • Private healthcare insurance
  • Long-term illness cover
  • Death in service cover
  • Salary sacrifice pension
  • Annual leave
  • Paid maternity & paternity leave
  • Volunteer day

What Sets Us Apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

  • Access Programs
  • Clinical Trial Services
  • Patient Site Solutions
  • Clinical Trial Supply
  • Market Access and Commercialization

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment. WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

Senior Clinical Quality Assurance Manager employer: WEP Clinical

At WEP Clinical, we pride ourselves on being an exceptional employer that fosters a culture of innovation and collaboration. Our commitment to employee growth is evident through comprehensive training programmes and wellness initiatives, ensuring that our team members thrive both personally and professionally. Located in a dynamic environment, we offer competitive benefits including private healthcare, generous leave policies, and a strong focus on diversity, equity, and inclusion, making WEP Clinical a truly rewarding place to work.
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Contact Detail:

WEP Clinical Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Senior Clinical Quality Assurance Manager

✨Tip Number 1

Familiarise yourself with the latest GCP guidelines and regulatory requirements. This knowledge will not only help you in interviews but also demonstrate your commitment to maintaining high-quality standards in clinical research.

✨Tip Number 2

Network with professionals in the clinical quality assurance field. Attend industry conferences or webinars to connect with others and learn about current trends, which can give you an edge when discussing your insights during the interview.

✨Tip Number 3

Prepare to discuss specific examples of how you've implemented quality assurance processes in previous roles. Highlighting your hands-on experience will showcase your ability to contribute effectively to WEP Clinical's mission.

✨Tip Number 4

Research WEP Clinical’s recent projects and initiatives. Understanding their work and values will allow you to tailor your responses in interviews, showing that you're genuinely interested in being part of their team.

We think you need these skills to ace Senior Clinical Quality Assurance Manager

Quality Management System (QMS) expertise
Good Clinical Practice (GCP) knowledge
Regulatory compliance (FDA, EMA)
Clinical trial methodologies
Risk assessment and mitigation
Audit and inspection management
Corrective and Preventive Actions (CAPA)
Change management processes
Training and development in quality assurance
Interpersonal and communication skills
Analytical and detail-oriented mindset
Experience with decentralized clinical trials
Data privacy laws knowledge (e.g., GDPR)
Process improvement strategies
Stakeholder engagement

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in clinical research and quality assurance. Emphasise your knowledge of GCP and any specific achievements that demonstrate your ability to manage quality systems effectively.

Craft a Compelling Cover Letter: In your cover letter, express your passion for clinical quality assurance and how your skills align with the role's objectives. Mention specific experiences that showcase your leadership and problem-solving abilities.

Highlight Relevant Skills: Focus on key skills mentioned in the job description, such as risk assessment, compliance management, and training delivery. Use examples from your past roles to illustrate how you have successfully applied these skills.

Showcase Your Adaptability: Given the dynamic nature of the role, provide examples of how you've adapted to changes in regulatory requirements or clinical practices. This will demonstrate your ability to thrive in a fast-paced environment.

How to prepare for a job interview at WEP Clinical

✨Showcase Your Leadership Skills

As a Senior Clinical Quality Assurance Manager, you'll need to demonstrate your ability to lead and make strategic decisions. Prepare examples from your past experiences where you successfully led a team or project, highlighting your decisiveness and adaptability.

✨Understand GCP and Regulatory Requirements

Make sure you're well-versed in Good Clinical Practice (GCP) and other regulatory requirements like FDA and EMA guidelines. Be ready to discuss how you've implemented these standards in previous roles and how you can ensure compliance at WEP Clinical.

✨Prepare for Scenario-Based Questions

Expect questions that assess your problem-solving skills and ability to handle quality incidents. Think of specific scenarios where you identified risks or non-conformances and the steps you took to address them. This will showcase your analytical and detail-oriented nature.

✨Emphasise Your Interpersonal Skills

Since this role involves liaising with various stakeholders, it's crucial to highlight your strong interpersonal skills. Prepare to discuss how you've effectively communicated with clients, team members, and regulatory bodies in the past, demonstrating your ability to foster collaboration.

Senior Clinical Quality Assurance Manager
WEP Clinical
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