At a Glance
- Tasks: Support GMP operations and ensure compliance with regulatory standards in a dynamic environment.
- Company: Join a leading organisation in cell and gene therapy innovation.
- Benefits: Permanent full-time role with opportunities for professional growth and development.
- Other info: Collaborative team culture with a focus on continuous improvement and learning.
- Why this job: Make a real impact in the life sciences sector while advancing your career.
- Qualifications: Bachelor's degree in Life Sciences and experience in regulated environments.
The predicted salary is between 36000 - 60000 £ per year.
Operations Compliance Officer
Application Deadline: 5 October 2025
Department: S-MIC Operations
Employment Type: Permanent - Full Time
Location: Stevenage (SMIC)
Overview
The role of Operations Compliance Officer actively supports the GMP operations at the CGT Catapult Stevenage Manufacturing Innovation Centre. Reporting to the Operations Lead, it is a hands-on position focused on delivering and continuously improving day-to-day operational processes within the facility. The role ensures full compliance with relevant regulatory standards (MHRA) through development, training and execution of internal policies and procedures while maintaining and building efficiency. This role provides critical support to internal stakeholders and collaborators delivering innovative cell and gene therapies manufactured at Stevenage MIC.
Key Responsibilities
Key Facilitators
- Act as the primary point of contact between CGT Catapult and SMIC Collaborators
- Schedule activities in shared areas and Grade C/B cleanroom modules to coordinate materials, equipment, waste, samples, cleaning and Environmental Monitoring with minimal disruption to manufacturing
- Collaborate with Quality Control, Quality Assurance, Engineering, Warehouse, Validation suppliers and service providers to support GMP-compliant operations
Facility Management
- Oversee facility operations to ensure compliance with procedures and policies
- Equipment Owner for operational equipment, ensuring it remains compliant and fit for purpose
- Monitor contract cleaning services to maintain GMP area standards and schedule
- Lead the spills management process and serve as an active member of the spills team
- Assist the Warehouse team in managing inventory to ensure continuous supply
- Manage waste processes, including Human Tissue Waste and Large Volume Liquid Waste, ensuring compliant handling and disposal
- Ensure the operations team enables a safe working environment across SMIC, taking ownership of relevant risk assessments including COSHH and microbiological containment
Ensure Compliance
- Own and maintain operational policies and procedures within the QMS
- Ensure accurate, GMP-compliant completion of facility logbooks
- Manage Quality Records (e.g., Non-Conformance, Change Control, CAPA, OOS/LIR) to closure
- Participate in self-inspections and internal audits of operations-owned areas and processes
- Support the Operations Lead in preparing for and hosting external audits
- Escalate quality and health and safety risks to management promptly
Drive Continuous Improvement
- Conduct root cause investigations, GEMBA walks and process reviews to identify improvements
- Maintain Operational KPIs to measure departmental performance and drive improvement
- Design and deliver training on operational procedures to ensure consistent understanding and execution
- The role may also include other duties as required, in line with its scope
Experience
- Experience working in regulated environments, ideally GMP within cell and gene therapy or biopharma
- Hands-on experience of manufacturing operations, including scheduling, cleaning, supply chain, material transfer, microbiological containment, growing & waste management
- Demonstrated experience contributing to quality records including Deviations, CAPAs and Change Controls within a regulated framework
- Demonstrated skills in building strong cross-functional relationships and providing problem solving support to internal and external stakeholders
Skills, Knowledge and Expertise
- Understanding of GMP principles, cleanroom operations and regulatory compliance in a manufacturing environment (essential)
- Desire to contribute to the cell and gene sector with the personal drive to help advance CGT Catapult\'s mission (essential)
- Ability to manage multiple priorities, adapt to changing requirements and maintain high standards in a fast-paced, patient-focused environment (essential)
- Strong interpersonal, written and verbal communication skills utilised to build trust and collaborate across teams (essential)
- Self-motivated and solution-focused, confident to autonomously manage workload, take ownership and make sound decisions in complex situations (essential)
- Flexible and open to varied assignments, with a positive attitude towards learning, professional development, and staying up to date with industry\\\'s best practice (essential)
- Committed to excellent customer service and operational support, delivered in a cost-effective and efficient manner (essential)
- Proficient in IT applications (Outlook, Word, Excel, PowerPoint) (essential)
- Willingness to travel as required (essential)
- Capable of owning and managing quality records and processes within eQMS to support compliant quality culture, including supporting audits
- Working knowledge of Lean Manufacturing methodologies, with the ability to identify and implement process improvement
- Familiarity with eQMS and EMS systems
Education / Qualifications
- Bachelor\'s degree in Life Sciences or equivalent
Operations Compliance Officer employer: Cell and Gene Therapy Catapult
At CGT Catapult, we pride ourselves on being an exceptional employer, particularly for the Operations Compliance Officer role at our Stevenage Manufacturing Innovation Centre. Our collaborative work culture fosters innovation and continuous improvement, while our commitment to employee growth is evident through comprehensive training and development opportunities. With a focus on compliance and operational excellence in the cutting-edge field of cell and gene therapies, we offer a unique chance to contribute to meaningful advancements in healthcare within a supportive and dynamic environment.
Contact Details:
Cell and Gene Therapy Catapult Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Operations Compliance Officer
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. We can’t stress enough how valuable personal connections can be in landing that Operations Compliance Officer role.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their mission in cell and gene therapy and think about how your skills align with their goals. We want you to shine when you get that chance to impress!
✨Tip Number 3
Practice common interview questions related to GMP compliance and operational processes. We suggest doing mock interviews with friends or mentors to build confidence and refine your answers.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in showing your enthusiasm for the role. And remember, apply through our website for the best chance at landing that dream job!
We think you need these skills to ace Operations Compliance Officer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Operations Compliance Officer role. Highlight your experience in GMP environments and any relevant skills that match the job description. We want to see how you can contribute to our mission!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about cell and gene therapies and how your background makes you a perfect fit for our team. Keep it engaging and personal, so we get a sense of who you are.
Showcase Your Skills:Don’t forget to showcase your strong interpersonal and communication skills in your application. We value collaboration, so let us know how you've built relationships and solved problems in past roles. It’s all about teamwork!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes directly to us. Plus, you’ll find all the details you need right there!
How to prepare for a job interview at Cell and Gene Therapy Catapult
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practice (GMP) principles and how they apply to the role. Be ready to discuss specific examples from your past experience where you've ensured compliance or improved processes in a regulated environment.
✨Showcase Your Problem-Solving Skills
Prepare to share instances where you've tackled challenges in manufacturing operations. Highlight your ability to manage multiple priorities and adapt to changing requirements, as this is crucial for the Operations Compliance Officer role.
✨Build Rapport with Stakeholders
Since this role involves collaboration with various teams, think of ways to demonstrate your strong interpersonal skills. Share examples of how you've built relationships and provided support to internal and external stakeholders in previous positions.
✨Be Ready for Technical Questions
Expect questions about quality records, audits, and compliance processes. Brush up on your knowledge of eQMS and Lean Manufacturing methodologies, and be prepared to discuss how you've applied these in your work.
