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- Tasks: Ensure compliance with regulations and certify batches for market release.
- Company: Join Replimune, a pioneering company revolutionising cancer treatment.
- Benefits: Enjoy a competitive rewards program and a collaborative work culture.
- Why this job: Make a real impact on patients' lives while working in an innovative environment.
- Qualifications: B.A/B.S in a scientific field; experience in pharmaceuticals required.
- Other info: Opportunity to lead quality assurance in advanced therapy medicinal products.
The predicted salary is between 48000 - 84000 £ per year.
Replimune – Abingdon‑On‑Thames, England, United Kingdom
Qualified Person
We are looking for a Qualified Person (QP) to ensure each batch of product is manufactured, inspected and released in compliance with UK or EU regulations, Good Manufacturing Practice (GMP), and the relevant marketing authorisation or clinical trial authorisation.
Job Summary
The QP will be responsible for the full quality assurance chain, from batch record review to certification, and will work closely with manufacturing, quality control, and regulatory teams to safeguard product quality and patient safety.
Responsibilities
- Ensure each batch is certified for release in compliance with Eudralex Volume 4, Annex 16, and local regulations.
- Maintain a calibration and audit register and record all certifications.
- Review batch records, QC data, cleaning logs, stability data, and supply‑chain information prior to release.
- Confirm that all manufacturing and quality control activities are performed in accordance with GMP principles.
- Ensure all sites involved in production, QC, distribution, and certification are licensed and compliant.
- Validate manufacturing and testing processes and confirm that acceptance criteria have been met.
- Verify that all materials, including active ingredients and excipients, meet regulatory specifications.
- Oversee post‑marketing monitoring, complaints, inspections and recalls, ensuring that any outstanding issues do not compromise certification.
- Lead investigations of quality defects and engage with the relevant departments to implement corrective and preventive actions.
- Co‑ordinate batch release for both commercial and clinical products intended for the EU and UK.
- Provide guidance on good documentation practice and support continuous improvement initiatives.
Qualifications – Education
B.A. or B.S. in a scientific discipline; M.S., Ph.D. or equivalent postgraduate qualification encouraged.
Qualifications – Experience
- Qualified Person status under Article 49 of the 2001/83/EC regulation.
- Minimum of 2 years relevant pharmaceutical experience, preferably with steriles or Advanced Therapy Medicinal Products (ATMP).
- In‑depth knowledge of EU, UK GMP guidelines and continuous professional development of regulatory and industry updates.
About Replimune
Replimune Group, Inc. is headquartered in Woburn, MA and focuses on transforming cancer treatment through oncolytic immunotherapies. Our proprietary RPx platform delivers a dual local‑and‑systemic response, aiming to transform cancer care and create new therapies for patients worldwide.
We are an Equal Opportunity Employer.
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Qualified Person employer: Replimune
Contact Detail:
Replimune Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person
✨Tip Number 1
Familiarise yourself with the specific regulations and guidelines related to GMP in the EU and UK. Understanding these will not only help you in interviews but also demonstrate your commitment to compliance, which is crucial for a Qualified Person.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who work with Advanced Therapy Medicinal Products (ATMP). Engaging in conversations can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Stay updated on the latest developments in cancer treatment and clinical trials. Being knowledgeable about current trends and innovations can set you apart during discussions with potential employers at Replimune.
✨Tip Number 4
Prepare to discuss real-life scenarios where you've ensured compliance with GMP or handled quality control issues. Having concrete examples ready will showcase your experience and problem-solving skills, making you a strong candidate for the position.
We think you need these skills to ace Qualified Person
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in compliance with GMP and your understanding of EU and UK regulations. Emphasise any specific roles or projects that relate to the responsibilities of a Qualified Person.
Craft a Compelling Cover Letter: In your cover letter, express your passion for revolutionising cancer treatment and how your skills align with Replimune's mission. Mention specific experiences that demonstrate your ability to ensure compliance and quality in pharmaceutical processes.
Highlight Relevant Qualifications: Clearly state your educational background, especially if you hold a B.A or B.S degree in a scientific field. If you have a postgraduate degree, make sure to mention it as it is encouraged for this role.
Showcase Continuous Professional Development: Mention any ongoing training or certifications related to GMP and regulatory knowledge. This shows your commitment to staying updated in the field, which is crucial for a Qualified Person.
How to prepare for a job interview at Replimune
✨Understand the Regulatory Landscape
Familiarise yourself with EU and UK regulations regarding Good Manufacturing Practices (GMP). Be prepared to discuss how these regulations impact the role of a Qualified Person and demonstrate your knowledge of compliance requirements.
✨Showcase Your Experience
Highlight your relevant experience in the pharmaceutical industry, especially any work related to Advanced Therapy Medicinal Products (ATMP). Be ready to provide specific examples of how you've ensured compliance and quality in previous roles.
✨Emphasise Collaboration Skills
Replimune values collaboration, so be sure to discuss your ability to work effectively within teams. Share examples of how you've collaborated with cross-functional teams to achieve common goals, particularly in high-stakes environments.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and decision-making process. Think about past challenges you've faced in batch certification or quality control, and how you navigated those situations to ensure compliance and safety.
