Description
The role of Operations Compliance Officer actively supports the Good Manufacturing Practice (GMP) operations at the CGT Catapult Stevenage Manufacturing Innovation Centre.. Reporting to the Operations Lead, it's 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. In doing so, this role provides critical support to internal stakeholders and our 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 co-ordinate 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 this remains compliant and fit for purpose
* Monitor contract cleaning services to maintain GMP areas 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 (i.e. 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 but not limited to; 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, Work, 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
About Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult (CGT Catapult) is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector.
With experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation.
The Cell and Gene Therapy Catapult works with Innovate UK.
CGT Catapult is committed to providing an equal, diverse, and inclusive work environment where everyone's contributions are valued. We celebrate differences, empower, and inspire everyone, because when everyone is included, everyone wins. In 2024, we received bronze accreditation from Inclusive Employers.