At a Glance
- Tasks: Lead and develop a GCP Quality team, ensuring inspection readiness and compliance.
- Company: Join a fast-paced biotech company focused on global clinical programs.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and leadership.
- Why this job: Shape quality systems and drive a quality-first culture in clinical trials.
- Qualifications: 10+ years in Clinical Quality Assurance with deep GCP expertise required.
- Other info: Ideal for leaders who motivate teams and thrive in agile settings.
The predicted salary is between 72000 - 108000 £ per year.
George Higginson is currently searching for an experienced Director, Quality (GCP), with over a decade of experience in GCP, preferably across Ph. We’re looking for a true leader in GCP Quality to drive strategy and oversight across global clinical programs through Phase II, Phase III, and into commercialisation.
You’ll head up a growing QA team and play a key role in shaping quality systems and ensuring inspection readiness in a fast-paced biotech environment.
- Lead and develop the GCP Quality team, overseeing strategy, execution, and continuous improvement.
- Define and implement GCP Quality oversight across internal functions and external partners.
- Ensure inspection readiness and represent QA in global audits (FDA, EMA, MHRA).
- Advise on clinical compliance, risk management, and quality system development.
- Partner with senior stakeholders to embed a quality-first culture across clinical programs.
10+ years of Clinical Quality Assurance experience with deep GCP expertise across Phase 2 and 3 trials.
Global regulatory knowledge (US, EU, UK) and hands-on inspection/audit experience.
Experience in risk-based audit planning, vendor oversight, and quality performance monitoring.
Bachelor’s degree in life sciences required; Bonus Points For: Someone who leads by example, motivates teams, and thrives in a dynamic, agile environment.
Director Quality Management employer: AL Solutions
Contact Detail:
AL Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Quality Management
✨Tip Number 1
Network with professionals in the biotech and clinical quality assurance fields. Attend industry conferences or webinars where you can meet potential colleagues and leaders in GCP Quality. Building these connections can provide insights into the company culture and expectations.
✨Tip Number 2
Stay updated on the latest trends and regulations in GCP and clinical quality assurance. Subscribe to relevant journals or follow key thought leaders on social media. This knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 3
Prepare to discuss specific examples of how you've led teams and implemented quality systems in previous roles. Be ready to share your experiences with inspection readiness and audit processes, as these are crucial for the role.
✨Tip Number 4
Research StudySmarter's values and mission. Tailor your conversations during interviews to align with our focus on quality and innovation in education. Showing that you understand and resonate with our goals can set you apart from other candidates.
We think you need these skills to ace Director Quality Management
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in GCP Quality Management, particularly in Phase II and III trials. Use specific examples that demonstrate your leadership skills and your ability to drive strategy and oversight.
Craft a Compelling Cover Letter: In your cover letter, emphasise your 10+ years of Clinical Quality Assurance experience and your global regulatory knowledge. Discuss how you can contribute to shaping quality systems and ensuring inspection readiness in a fast-paced biotech environment.
Highlight Relevant Achievements: Include specific achievements related to risk management, audit planning, and vendor oversight in your application. Quantify your successes where possible to showcase your impact in previous roles.
Showcase Leadership Qualities: Demonstrate your leadership style and how you motivate teams in your application. Provide examples of how you've embedded a quality-first culture in past positions, as this is crucial for the role.
How to prepare for a job interview at AL Solutions
✨Showcase Your Leadership Skills
As a Director of Quality Management, demonstrating your leadership abilities is crucial. Prepare examples of how you've successfully led teams in the past, particularly in GCP environments. Highlight your experience in motivating teams and driving strategy.
✨Demonstrate Regulatory Knowledge
Familiarise yourself with global regulatory requirements, especially those from the FDA, EMA, and MHRA. Be ready to discuss how your knowledge has influenced your previous roles and how you can apply it to ensure compliance in clinical trials.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think about challenges you've faced in quality assurance and how you managed them, particularly in fast-paced biotech settings.
✨Emphasise Continuous Improvement
Highlight your commitment to continuous improvement in quality systems. Discuss specific initiatives you've implemented in the past that have led to enhanced quality oversight or inspection readiness, showcasing your proactive approach.