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- 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 thrive in agile environments and motivate teams.
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 for Quality employer: AL Solutions
Contact Detail:
AL Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director for Quality
✨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 give you insights into the company culture and expectations.
✨Tip Number 2
Stay updated on the latest trends and regulations in GCP and clinical quality assurance. Follow relevant publications, join professional groups, and engage in discussions to demonstrate your knowledge and passion for the field during interviews.
✨Tip Number 3
Prepare to discuss specific examples of how you've led teams and implemented quality systems in previous roles. Highlight your experience with inspection readiness and audits, as these are crucial for the Director role at StudySmarter.
✨Tip Number 4
Research StudySmarter's current projects and values. Understanding our mission and how we approach quality assurance will help you align your answers with our goals during the interview process, showcasing that you're a great fit for the team.
We think you need these skills to ace Director for Quality
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in GCP Quality Assurance, particularly in Phase II and III trials. Use specific examples to demonstrate your leadership skills and achievements in previous roles.
Craft a Compelling Cover Letter: In your cover letter, emphasise your ability to drive strategy and oversight in clinical programs. Mention your experience with global regulatory knowledge and how you can contribute to a quality-first culture within the company.
Showcase Relevant Experience: Detail your hands-on inspection and audit experience, as well as your expertise in risk management and quality system development. Be specific about your role in previous audits and how you ensured inspection readiness.
Highlight Leadership Qualities: Since the role requires leading a growing QA team, make sure to illustrate your leadership style. Share examples of how you've motivated teams and thrived in dynamic environments, showcasing your ability to lead by example.
How to prepare for a job interview at AL Solutions
✨Showcase Your Leadership Skills
As a Director for Quality, it's crucial to demonstrate your leadership abilities. Prepare examples of how you've successfully led teams in the past, particularly in GCP environments. Highlight your experience in motivating teams and driving quality-first cultures.
✨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 programmes.
✨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 GCP Quality Assurance and how you navigated them, particularly in high-pressure environments.
✨Emphasise Continuous Improvement
The role requires a focus on continuous improvement. Be prepared to discuss specific initiatives you've implemented in the past that enhanced quality systems or processes. Show how you measure success and adapt strategies based on performance monitoring.
