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- Tasks: Lead supplier management and ensure compliance in a dynamic biopharmaceutical environment.
- Company: Join a leading biopharmaceutical organisation making waves in CAR T-cell therapies.
- Benefits: Enjoy hybrid working, competitive salary, and opportunities for professional growth.
- Why this job: Be part of a mission-driven team improving lives through innovative therapies and quality assurance.
- Qualifications: Strong communication skills and experience in regulated environments are essential.
- Other info: This role offers a chance to influence quality improvements and mentor a dedicated QA team.
The predicted salary is between 36000 - 60000 £ per year.
2 days ago Be among the first 25 applicants
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Direct message the job poster from Blackfield Associates
Lead Quality Assurance Consultant – United Kingdom & Ireland
Blackfield are working with a leading biopharmaceutical organisation based in Stevenage in the search for a Senior Specialist, Supplier Management on a hybrid basis.
The Senior Specialist, QA Supplier Management will be a pivotal member of the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for both clinical and commercial use across the UK, EU, and US. This position will ensure compliance with Good Manufacturing Practice (GMP) and uphold the Pharmaceutical Quality System , with a particular focus on supplier qualification, auditing, and ongoing vendor oversight. Acting as a Subject Matter Expert in supplier management, quality documentation, and inspection readiness, the role will also contribute to continuous improvements across all quality systems and processes.
Key Responsibilities:
- Manage the qualification, auditing, and continued oversight of third-party suppliers, ensuring that only approved materials and services are utilised in production and quality control.
- Review and approve GxP documentation, including Batch Manufacturing Records, SOPs, validation protocols, and quality reports, escalating issues when necessary.
- Lead internal audits, coordinate inspection readiness activities, and act as SME during regulatory inspections.
- Deliver training, mentoring, and operational leadership to the QA team, deputising for the QA Manager and supporting manufacturing authorisations and licence variations.
The ideal candidate will demonstrate excellent communication skills, a collaborative approach, and a proven ability to lead projects in a regulated environment. They will possess the confidence to influence stakeholders, build strong cross-functional relationships, and drive quality improvements within complex operations.
If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance
-
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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Senior QA Specialist, Supplier Management employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA Specialist, Supplier Management
✨Tip Number 1
Familiarise yourself with Good Manufacturing Practice (GMP) guidelines and the Pharmaceutical Quality System. Being well-versed in these areas will not only boost your confidence during interviews but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, especially those involved in supplier management and quality assurance. Engaging with them on platforms like LinkedIn can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed supplier qualifications and audits in previous roles. Highlighting your experience as a Subject Matter Expert will set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest trends and challenges in the biopharmaceutical sector, particularly regarding CAR T-cell products. This knowledge will help you engage in meaningful conversations during interviews and show your passion for the field.
We think you need these skills to ace Senior QA Specialist, Supplier Management
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance and supplier management. Emphasise your familiarity with Good Manufacturing Practice (GMP) and any specific projects you've led that relate to the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance in the biopharmaceutical sector. Mention specific examples of how you've contributed to compliance and quality improvements in previous roles.
Highlight Key Skills: Focus on key skills mentioned in the job description, such as auditing, vendor oversight, and documentation review. Use concrete examples to demonstrate your expertise in these areas.
Showcase Leadership Experience: Since the role involves mentoring and leading a QA team, be sure to include any leadership experiences you have. Discuss how you've influenced stakeholders and driven quality improvements in past positions.
How to prepare for a job interview at Blackfield Associates
✨Understand GMP and Quality Systems
Make sure you have a solid grasp of Good Manufacturing Practice (GMP) and the Pharmaceutical Quality System. Be prepared to discuss how these principles apply to supplier management and quality assurance in your previous roles.
✨Showcase Your Auditing Experience
Highlight your experience with supplier qualification and auditing. Be ready to provide examples of how you've successfully managed third-party suppliers and ensured compliance with quality standards.
✨Demonstrate Leadership Skills
As this role involves mentoring and leading the QA team, be prepared to discuss your leadership style and any relevant experiences. Share specific instances where you've influenced stakeholders or driven quality improvements.
✨Prepare for Regulatory Inspection Scenarios
Since you'll act as a Subject Matter Expert during regulatory inspections, think about potential questions or scenarios that could arise. Practice articulating your approach to inspection readiness and how you would handle unexpected challenges.