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- Tasks: Drive GMP excellence and shape quality systems for life-changing therapies.
- Company: Proclinical, a growing leader in rare disease and pharmaceuticals.
- Benefits: Competitive salary, dynamic work environment, and opportunities for professional growth.
- Why this job: Make a real impact on quality assurance in the pharmaceutical sector.
- Qualifications: Degree in science or life sciences; expertise in GMP oversight required.
- Other info: Collaborative culture with a focus on continuous improvement and career development.
The predicted salary is between 60000 - 80000 ÂŁ per year.
Drive GMP excellence and shape quality systems that support life‑changing rare disease therapies. Proclinical is seeking a GMP QA Manager to join a growing team in the rare disease and pharmaceutical sector. In this role, you will ensure compliance with GxP regulations, oversee quality assurance for investigational medicinal product (IMP) manufacturing, and contribute to the development of quality systems that align with clinical and manufacturing needs. This position offers an opportunity to collaborate across multiple functions and drive continuous improvement in a dynamic environment.
Responsibilities
- Ensure adherence to GxP compliance regulations, including standard operating procedures and approved documentation.
- Provide end-to-end quality assurance oversight for IMP manufacturing, including batch record review, QC data approval, and clinical trial release certification.
- Maintain and improve elements of the Quality Management System (QMS), ensuring risk‑based and phase‑appropriate processes for clinical development.
- Manage deviations, investigations, root cause analyses, and CAPAs, ensuring timely closure and effective corrective actions.
- Support cross‑GxP alignment by integrating GCP knowledge into manufacturing, clinical operations, and trial supply activities.
- Collaborate with Clinical QA to ensure traceability, chain‑of‑custody integrity, and audit readiness throughout the clinical supply lifecycle.
- Partner with CMC, Clinical Operations, Regulatory Affairs, Supply Chain, and Development teams to embed quality principles into planning and execution.
- Provide training, coaching, and QA guidance to internal teams and external partners to enhance GxP awareness and compliance.
- Drive a culture of continuous improvement by identifying process gaps and implementing scalable solutions.
- Contribute to the strategic development of the Quality function, ensuring phase‑appropriate processes and supporting risk assessments and decision‑making.
Key Skills and Requirements
- Degree in science, life sciences, or a related field.
- Expertise in GMP oversight of IMP manufacturing, QC, and batch disposition for clinical trials.
- Knowledge of global GMP regulations, including Eudralex vol. 4, cGMPs, Good Documentation Practices, and Data Integrity (ALCOA).
- Experience authoring and reviewing GxP documents such as SOPs, forms, templates, and QTAs.
- Working knowledge of GCP to provide cross‑GxP coverage.
- Proficiency in risk‑based QMS processes, including deviation management, root cause analysis, and CAPA implementation.
- Vendor management experience, including audits, CDMOs, labs, and inspection readiness.
- Familiarity with equipment validation and environmental monitoring of cold storage areas.
- Strong analytical and critical thinking skills with pragmatic decision‑making abilities.
- Effective communication skills to engage technical and non‑technical stakeholders.
- Ability to work autonomously and train internal teams and external partners.
- Resilience and adaptability in a fast‑paced, scaling biotech environment.
GMP QA Manager in Chertsey employer: Proclinical Group
Contact Detail:
Proclinical Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GMP QA Manager in Chertsey
✨Tip Number 1
Network like a pro! Reach out to professionals in the GMP and QA space on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your GxP knowledge and real-world applications. We recommend practising common interview questions related to quality assurance and compliance to show you’re the right fit for the role.
✨Tip Number 3
Showcase your experience with specific examples during interviews. We want to hear about your past successes in managing deviations or implementing CAPAs. This will help you stand out as a candidate who can drive GMP excellence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace GMP QA Manager in Chertsey
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that align with the GMP QA Manager role. Highlight your expertise in GMP oversight and any relevant projects you've worked on, especially those related to rare diseases.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about quality assurance in the pharmaceutical sector. Share specific examples of how you've driven compliance and continuous improvement in previous roles.
Showcase Your Knowledge: Demonstrate your understanding of GxP regulations and quality management systems in your application. Mention any experience you have with deviation management or CAPA implementation to show us you're the right fit for the role.
Apply Through Our Website: We encourage you to apply directly through our website. This way, we can easily track your application and ensure it gets the attention it deserves. Plus, it’s the best way to stay updated on your application status!
How to prepare for a job interview at Proclinical Group
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of GMP regulations and guidelines, especially Eudralex vol. 4 and cGMPs. Be ready to discuss how you've applied these in past roles, particularly in IMP manufacturing and quality assurance.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've managed deviations, conducted root cause analyses, and implemented CAPAs. Highlight specific situations where your actions led to successful outcomes, demonstrating your analytical and critical thinking abilities.
✨Emphasise Collaboration
This role requires working with various teams, so be ready to talk about your experience collaborating across functions like Clinical Operations and Regulatory Affairs. Share instances where you’ve successfully integrated quality principles into team projects.
✨Be Ready for Scenario Questions
Expect scenario-based questions that test your decision-making in a fast-paced environment. Think about how you would handle specific challenges related to quality systems and compliance, and articulate your thought process clearly.