Operations Compliance Officer

Cell and Gene Therapy Catapult; Stevenage; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading biopharmaceutical organization in Stevenage is seeking an Operations Compliance Officer to ensure GMP compliance and support operational efficiency. The role involves managing facility operations, quality records, and training to advance innovative therapies. The ideal candidate has a Bachelor's in Life Sciences and experience in regulated environments. Opportunities for professional growth and a commitment to diversity and inclusion are core to the organization's values.

Benefits

Diverse and inclusive work environment

Professional development opportunities

Qualifications

• Experience in regulated environments, ideally GMP within cell and gene therapy.
• Hands-on experience of manufacturing operations.
• Proven ability to manage quality records in a regulated framework.

Responsibilities

• Act as point of contact for CGT Catapult and collaborators.
• Oversee facility operations for compliance.
• Manage Quality Records to closure.

Skills

Understanding of GMP principles

Strong interpersonal skills

Proficiency in IT applications

Ability to manage multiple priorities

Flexibility and openness to varied assignments

Education

Bachelor's degree in Life Sciences

Tools

Outlook

Excel

PowerPoint

Job description

Overview

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.

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, gowning & 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

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.