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- Tasks: Lead Quality Assurance efforts and ensure compliance with GMP regulations.
- Company: Join a dynamic pharmaceutical organization focused on quality and compliance.
- Benefits: Shape the company's strategy and drive culture change in a leadership role.
- Why this job: Make a real impact on product quality and team development in a collaborative environment.
- Qualifications: Must be a Qualified Person (QP) with extensive QA experience and leadership skills.
- Other info: This is a fully on-site position, perfect for those ready to lead at the highest level.
The predicted salary is between 72000 - 108000 £ per year.
Job Description
AssureBio is supporting a pharmaceutical organisation in the search for an accomplished Quality Director & Qualified Person (QP). This is a critical leadership role requiring an individual with extensive Quality Assurance expertise, strategic leadership capabilities, and a commitment to driving culture change and continuous improvement.
As a key member of the leadership team, you will play a pivotal role in embedding a quality-first mindset across the organisation, ensuring GMP compliance, regulatory excellence, and the continuous supply of medicinal products to market. This is a fully on-site position, offering a unique opportunity to shape the company’s Quality and Compliance strategy at the highest level.
Key responsibilities include:
- Providing strategic leadership across Quality teams to ensure efficient product evaluation and release.
- Acting as the Named QP on the company’s Manufacturer and Importer Authorisations.
- Leading regulatory inspections and internal self-inspections.
- Overseeing and evolving the Pharmaceutical Quality Management System, ensuring alignment with current GMP regulations and industry best practices.
- Driving a culture of continuous improvement and ensuring effective cross-functional collaboration with Regulatory Affairs, Validation, Sales, Logistics, and Manufacturing.
- Developing and mentoring the QA team, fostering a high-performance, improvement-driven culture.
- Leading complex investigations, including manufacturing deviations and out-of-specification/trend testing.
- Auditing contract manufacturers and laboratories to ensure compliance with EU GMP regulations.
What We’re Looking For:
- Qualified Person (QP) status – Essential.
- Extensive experience in manufacturing and testing of non-sterile dosage forms.
- Proven leadership in a Quality function, with experience managing a QA team.
- Strong ability to influence and drive culture change within an organisation.
- Experience in leading cross-functional teams is highly desirable.
- Excellent problem-solving skills and the ability to navigate complex regulatory environments.
- Adaptability and a continuous improvement mindset to refine processes and enhance compliance.
Quality Director and QP employer: AssureBio
Contact Detail:
AssureBio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Director and QP
✨Tip Number 1
Make sure to highlight your experience in leading Quality Assurance teams during networking events or industry conferences. Engaging with professionals in the pharmaceutical sector can help you gain insights and potentially get referrals for the Quality Director position.
✨Tip Number 2
Familiarize yourself with the latest GMP regulations and industry best practices. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to quality and compliance during interviews.
✨Tip Number 3
Consider reaching out to current or former employees of the organization to learn more about their culture and expectations. This insider knowledge can help you tailor your approach and show how you can contribute to driving a quality-first mindset.
✨Tip Number 4
Prepare specific examples of how you've successfully led cross-functional teams and driven culture change in previous roles. These stories will be crucial in showcasing your leadership capabilities and problem-solving skills during the interview process.
We think you need these skills to ace Quality Director and QP
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly understand the responsibilities and requirements of the Quality Director & Qualified Person position. Highlight your relevant experience in Quality Assurance and leadership in your application.
Tailor Your CV: Customize your CV to reflect your extensive experience in manufacturing and testing non-sterile dosage forms. Emphasize your leadership roles and any specific achievements that demonstrate your ability to drive culture change and continuous improvement.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your strategic vision for embedding a quality-first mindset. Mention your experience with regulatory compliance and how you can contribute to the company's Quality and Compliance strategy.
Highlight Leadership Experience: In both your CV and cover letter, make sure to highlight your proven leadership in a Quality function. Provide examples of how you've successfully managed QA teams and led cross-functional collaborations to achieve compliance and improve processes.
How to prepare for a job interview at AssureBio
✨Showcase Your Leadership Experience
As a Quality Director, your leadership skills are crucial. Be prepared to discuss specific examples of how you've led teams in the past, particularly in driving culture change and continuous improvement.
✨Demonstrate Your Regulatory Knowledge
Since this role involves ensuring GMP compliance and leading regulatory inspections, brush up on your knowledge of current regulations. Be ready to discuss how you've navigated complex regulatory environments in previous roles.
✨Highlight Cross-Functional Collaboration
This position requires effective collaboration with various departments. Prepare to share experiences where you've successfully worked with teams like Regulatory Affairs, Validation, and Manufacturing to achieve quality objectives.
✨Prepare for Problem-Solving Scenarios
Expect to be asked about how you handle challenges, such as manufacturing deviations or out-of-specification results. Think of specific instances where your problem-solving skills made a significant impact.
