Quality Director / QP

Quality Director / QP

Newcastle upon Tyne Full-Time 43200 - 72000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead a quality team and ensure compliance for innovative biotech products.
  • Company: Join a pioneering biotech firm focused on life-saving therapies in the North East.
  • Benefits: Enjoy an attractive package, remote work options, and career growth opportunities.
  • Why this job: Shape the future of healthcare with cutting-edge biologics and advanced therapies.
  • Qualifications: Must be eligible as a Qualified Person with leadership experience in GMP roles.
  • Other info: Be part of a mission-driven company making a real impact on patient lives.

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

Are you looking to work with ATMPs and biotechnology products? Do you want to operate at the cutting edge of Life Sciences? Are you ready to shape the future by leading a high-performing quality team?

A pioneering biotech organisation in the North East is seeking a Director of Quality (QP) to join its growing team. This is a unique opportunity to play a pivotal role in the development and release of novel advanced therapy medicinal products (ATMPs) and biologics that are changing the future of healthcare.

With a focus on patient impact, this company’s pipeline is packed with breakthrough therapies in clinical and pre-commercial phases. You will be joining at a critical time, with real opportunity to put your stamp on quality strategy, systems, and culture.

Key Responsibilities:

  • Act as the Qualified Person (QP) for the certification and release of ATMPs and biologic products
  • Provide strategic leadership across GMP compliance, QA systems, and continuous improvement
  • Build and develop a high-performing QA team, fostering a strong quality culture across operations
  • Oversee all aspects of GxP inspections, audits, and regulatory submissions
  • Partner cross-functionally with Manufacturing, Regulatory, and R&D to ensure quality is embedded at every stage

About You:

  • Eligible to act as a Qualified Person under UK regulations (Directive 2001/83/EC)
  • Proven leadership experience in GMP quality roles, ideally within ATMPs, biologics, or cell/gene therapy
  • Strong knowledge of MHRA, EMA, and FDA regulatory expectations
  • Comfortable working in a fast-paced, evolving environment where innovation is the norm
  • Passionate about mentoring others and scaling up quality teams and systems

Why Apply?

  • Join a mission-driven company focused on life-saving innovation
  • Work with cutting-edge biologics and advanced therapies
  • Influence company direction and build your own team from the ground up
  • Attractive package and long-term career progression in a high-growth environment

Quality Director / QP employer: ARx Recruitment Services

This pioneering biotech organisation in the North East is an exceptional employer, offering a unique opportunity to lead a high-performing quality team at the forefront of life sciences. With a strong focus on patient impact and a commitment to innovation, employees benefit from a collaborative work culture that fosters professional growth and development, alongside an attractive compensation package. Join us to influence the future of healthcare while working with cutting-edge biologics and advanced therapies in a dynamic and supportive environment.
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Contact Detail:

ARx Recruitment Services Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Quality Director / QP

✨Tip Number 1

Network with professionals in the biotechnology and life sciences sectors. Attend industry conferences, webinars, or local meetups to connect with others who work with ATMPs and biologics. This can help you gain insights into the latest trends and potentially lead to referrals.

✨Tip Number 2

Stay updated on regulatory changes from MHRA, EMA, and FDA. Subscribe to relevant newsletters or follow these organisations on social media. Demonstrating your knowledge of current regulations during interviews can set you apart as a candidate.

✨Tip Number 3

Showcase your leadership skills by engaging in quality improvement initiatives in your current role. Whether it's leading a project or mentoring colleagues, having concrete examples of how you've built a quality culture will resonate well with potential employers.

✨Tip Number 4

Research the company’s pipeline and recent developments in their therapies. Being knowledgeable about their products and how they impact patient care will demonstrate your genuine interest and commitment to their mission during the interview process.

We think you need these skills to ace Quality Director / QP

Qualified Person (QP) certification
GMP compliance expertise
Leadership and team development
Knowledge of ATMPs and biologics
Regulatory knowledge (MHRA, EMA, FDA)
Quality Assurance systems management
Experience with GxP inspections and audits
Cross-functional collaboration
Continuous improvement methodologies
Strong communication skills
Problem-solving abilities
Adaptability in fast-paced environments
Mentoring and coaching skills
Strategic thinking

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in GMP quality roles, particularly with ATMPs and biologics. Emphasise your leadership skills and any specific achievements that demonstrate your ability to build and develop high-performing teams.

Craft a Compelling Cover Letter: In your cover letter, express your passion for life sciences and innovation. Discuss how your background aligns with the company's mission and how you can contribute to shaping their quality strategy and culture.

Highlight Regulatory Knowledge: Clearly outline your understanding of MHRA, EMA, and FDA regulatory expectations in your application. This will show that you are well-prepared to oversee GxP inspections and audits.

Showcase Mentoring Experience: If you have experience mentoring others or scaling up quality teams, make sure to include this in your application. Highlight specific examples of how you've fostered a strong quality culture in previous roles.

How to prepare for a job interview at ARx Recruitment Services

✨Showcase Your Expertise in ATMPs

Make sure to highlight your experience with advanced therapy medicinal products (ATMPs) during the interview. Discuss specific projects you've worked on and how they relate to the role, demonstrating your understanding of the complexities involved in this field.

✨Emphasise Leadership Skills

As a Quality Director, you'll need to lead a high-performing team. Be prepared to share examples of how you've successfully built and developed teams in the past, focusing on your approach to fostering a strong quality culture and mentoring others.

✨Understand Regulatory Expectations

Familiarise yourself with the regulatory frameworks set by MHRA, EMA, and FDA. During the interview, be ready to discuss how you have navigated these regulations in previous roles and how you plan to ensure compliance in this new position.

✨Demonstrate Adaptability

This role requires working in a fast-paced and evolving environment. Share examples of how you've adapted to change in previous positions, showcasing your ability to thrive in dynamic settings while maintaining a focus on quality and compliance.

Quality Director / QP
ARx Recruitment Services
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