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- Tasks: Lead the development and validation of innovative test methods for gene therapy products.
- Company: Join a global leader in cutting-edge gene therapies addressing serious medical needs.
- Benefits: Enjoy opportunities for professional growth, training, and access to state-of-the-art facilities.
- Why this job: Make a real difference in people's lives while working in a dynamic, innovative environment.
- Qualifications: Degree in Human Health or Sciences with extensive experience in QC Validation and regulatory compliance.
- Other info: Willingness to travel between UK and Ireland sites is required.
The predicted salary is between 46200 - 50400 £ per year.
QC Validation Manager
Salary: £55,000 – £63,000
We are looking for an ambitious and driven QC Validation Manager to lead the development, validation, and lifecycle management of critical test methods for groundbreaking gene therapy products.
What You’ll Do:
- Lead Method Development: Spearhead the development and validation of both novel and established analytical methods for gene therapy products, driving innovation in therapeutic approaches.
- Lifecycle Management: Oversee the complete lifecycle management of assays, equipment, materials, and in-process samples, ensuring optimal performance and compliance throughout.
- Project Management: Be responsible for the implementation of test methods within defined timelines, enabling the seamless launch of new gene therapies.
- Compliance Champion: Ensure all methods are compliant with EU and FDA GMP regulations, maintaining data integrity and supporting regulatory submissions.
- External Testing Oversight: Manage and coordinate external testing activities, ensuring they align with internal quality standards and meet GMP requirements.
- Documentation Excellence: Generate and manage qualification/validation documentation, ensuring all analytical activities are well-documented and compliant with regulatory and internal standards.
- Cross-Functional Collaboration: Communicate effectively with stakeholders across departments, ensuring transparency and timely updates on projects.
- Training & Development: Lead the rollout of training for new technologies and methods, empowering your team to stay ahead of the curve in gene therapy advancements.
What Makes You a Great Fit:
- Extensive experience in the validation of analytical methods within the pharmaceutical or regulated industry, with a solid understanding of ATMPs and GMP regulations.
- You can identify issues quickly, develop innovative solutions, and inspire your team.
- Proven ability to manage multiple complex projects, delivering them on time while maintaining a high standard of quality and compliance.
- Deep knowledge of data integrity and good documentation practices, ensuring all processes are accurate, thorough, and fully compliant with regulatory requirements.
About our client:
- Global Impact: Work with a company that’s developing cutting-edge gene therapies to address serious unmet medical needs.
- Innovative Environment: Be part of a dynamic, forward-thinking team that embraces innovation and empowers you to make a real difference in people’s lives.
- Professional Growth: Opportunities for continuous learning and development as you work with the latest technologies and collaborate with experts across the globe.
- Cutting-Edge Facilities: Our clients’ state-of-the-art manufacturing and testing facilities are designed to meet the highest global regulatory standards, giving you the tools and environment you need to succeed.
What We’re Looking For:
- Degree in Human Health or Sciences, with extensive experience in the pharmaceutical or other highly regulated industries like biologics.
- Proven experience in a QC Validation role with a strong track record of successfully managing teams and delivering high-impact projects.
- Deep understanding of regulatory compliance, including GMP, EU and FDA requirements, and data integrity standards.
- Willingness to travel between our UK and Ireland sites as required.
If you’re ready to take your career to the next level and contribute to life-changing science, we want to hear from you.
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QC Validation Manager employer: CV-Library
Contact Detail:
CV-Library Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QC Validation Manager
✨Tip Number 1
Familiarize yourself with the latest trends and advancements in gene therapy and analytical method validation. This knowledge will not only help you stand out during interviews but also demonstrate your passion for the field.
✨Tip Number 2
Network with professionals in the pharmaceutical and gene therapy sectors. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest developments, which can give you an edge in discussions.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed complex projects in the past. Highlight your ability to meet tight deadlines while ensuring compliance with GMP and regulatory standards.
✨Tip Number 4
Showcase your leadership skills by discussing how you've trained and developed teams in previous roles. Emphasizing your experience in empowering others will resonate well with our focus on collaboration and innovation.
We think you need these skills to ace QC Validation Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in the validation of analytical methods, particularly within the pharmaceutical or regulated industry. Emphasize your understanding of ATMPs and GMP regulations.
Craft a Compelling Cover Letter: In your cover letter, express your passion for gene therapy and innovation. Discuss specific projects where you successfully managed complex QC validation tasks and how you ensured compliance with regulatory standards.
Highlight Project Management Skills: Clearly outline your project management experience, detailing how you've implemented test methods within defined timelines and maintained high standards of quality and compliance.
Showcase Cross-Functional Collaboration: Provide examples of how you've effectively communicated with stakeholders across departments. Highlight any training initiatives you've led that empowered your team to stay ahead in gene therapy advancements.
How to prepare for a job interview at CV-Library
✨Showcase Your Method Development Experience
Be prepared to discuss specific examples of analytical methods you have developed or validated in the past. Highlight any innovative approaches you took and how they contributed to successful gene therapy projects.
✨Demonstrate Project Management Skills
Share instances where you managed multiple complex projects simultaneously. Emphasize your ability to meet deadlines while ensuring compliance with GMP regulations and maintaining high-quality standards.
✨Emphasize Compliance Knowledge
Familiarize yourself with EU and FDA GMP regulations, as well as data integrity standards. Be ready to discuss how you have ensured compliance in previous roles and how you would approach this in the new position.
✨Highlight Cross-Functional Collaboration
Prepare to talk about your experience working with different departments. Effective communication is key, so provide examples of how you kept stakeholders informed and engaged throughout project lifecycles.
