14 of 14 Permanent 21 CFR Part 11 Jobs in the UK

software products. You'll be responsible for aligning information security and data protection with our mission to deliver FDA-regulated digital therapeutics. This includes leading regulatory security compliance (HIPAA, 21 CFR Part 11, FDA SaMD guidelines), proactively managing risk, and collaborating across engineering, product, compliance, and leadership teams. Location NYC, London, Ramat-Gan This role is … the opportunity to collaborate closely with our dynamic team in person. Responsibilities Design, implement, and lead Remepy's security practice and enterprise cybersecurity program Own security compliance with HIPAA, 21 CFR Part 11, FDA pre/postmarket cybersecurity guidance, and related frameworks Collaborate with Product, Engineering, and Compliance to embed security-by-design across our software More ❯

PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail … to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of … skills, and geographic location. The anticipated wage for this position is $63,750 - $180,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation More ❯

consistency across regulatory processes. 10+ years of experience in software lifecycle management and validation, with emphasis on pharma or biotech compliance. Solid knowledge of EU regulatory frameworks (e.g., GxP, 21 CFR Part 11, Annex 11). Experience preparing for and navigating ISO, SOC, and other third-party compliance audits. Strong documentation, project management, and cross More ❯

decision making in life sciences quality and compliance. The company's solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for We are looking for Salesforce Implementation … to become an integral part of our Professional Services team at Dot Compliance. At Dot Compliance, we strive to ensure customers' satisfaction and an effective onboarding process. As a Salesforce Implementation Specialist, you will work closely with the professional services global team to support technical activities during customer onboarding stage, develop custom solutions, tools and scripts to improve the … platform, allows life science customers to manage their quality and compliance Our ideal candidate should be passionate about learning new technologies, organizing information data, and keen on becoming a part of a growing and dynamic team. You will succeed in this role if you are a problem solver who likes to work with data and people to drive the More ❯

of successfully selling and overseeing complex and small-scale projects alike. Experience in technology implementation and migration projects within the life sciences industry (regulatory, quality, clinical) with regulated software (21 CFR Part 11, EU Annex 11). Proficiency in CRM solutions (e.g., Dynamics 365, Salesforce). Knowledge of project management methodologies (e.g., Agile, Waterfall) and More ❯

systems, HMI packages, building management systems, SCADA systems, and PC networking technology Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11 More ❯

Partner to implement and troubleshoot end-to-end solutions, supporting a robust and scalable environment. Compliance and Regulatory Adherence: Ensure all processes adhere to industry standards, GxP regulations, FDA 21 CFR Part 11, and internal governance frameworks. Monitor system performance and integration functionalities to support audit readiness and risk mitigation. Qualifications & Experience Experience: At least 10+ More ❯

technical training will be provided. Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21 CFR Part 11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required to client sites. What We More ❯

systems like LIMS, SCADA/HMI, and PLC-integrated devices. Collaborate with infrastructure teams and vendors to resolve escalated issues. Ensure compliance with Computer System Validation (CSV), GxP, and 21 CFR Part 11 standards. Document support activities accurately using the IT helpdesk system. Deliver technical onboarding and system usage training to end users. Proactively recommend improvements More ❯

About the Role We're hiring a Pre-Sales Technical Consultantto join a dynamic, mission-driven team transforming the way clinical trials are run. As part of a fast-growing healthtech startup, you'll play a key role in supporting commercial growth by bridging the gap between client needs and product capability. You'll work closely with both the … SaaS, cloud, or digital health. Strong understanding of enterprise sales cycles and client engagement across regulated industries. Clinical trial tech knowledge and familiarity with sector-specific standards (e.g. GCP, 21 CFR Part 11, GDPR) is a major plus. Excellent communication skills with the ability to present technical topics to both technical and non-technical audiences. Comfortable More ❯

driving secure, scalable DevOps practices across the organization. This includes building and automating infrastructure, championing compliance-ready CI/CD pipelines, and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance, and leadership teams to deliver infrastructure that meets the highest More ❯

driving secure, scalable DevOps practices across the organization. This includes building and automating infrastructure, championing compliance-ready CI/CD pipelines, and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance, and leadership teams to deliver infrastructure that meets the highest More ❯

system platforms desirable e.g., Siemens, Rockwell, Unicorn etc. • Experience with PLC, HMI, and SCADA an advantage. • Knowledge and familiarity with regulated industry standards, including exposure to cGMP, GAMP and 21 CFR Part 11. • Excellent communication skills and interpersonal skills. and Ability to work effectively in a fast-paced project. • Willing to work shift and in a team More ❯

system platforms desirable e.g., Siemens, Rockwell, Unicorn etc. • Experience with PLC, HMI, and SCADA an advantage. • Knowledge and familiarity with regulated industry standards, including exposure to cGMP, GAMP and 21 CFR Part 11. • Excellent communication skills and interpersonal skills. and Ability to work effectively in a fast-paced project. • Willing to work shift and in a team More ❯