the Cambridge, MA area. This Program manager role would engage cross functionally working with customer SMEs, Business Owners, Informatics Solution Owners, IT Teams, external customer groups ( eg. Validation and GXP process groups) and 3rd party vendor partner teams. Responsibilities: You will partner with the Business Systems owner in executing a slew of development projects involving Benchling ELN and Signals platforms More ❯
levels. Results-driven with a focus on innovation and continuous improvement. Proficiency in business intelligence and analytics tools (e.g., Tableau, Power BI). Knowledge of regulatory frameworks such as GxP, GDPR, SOX, or other compliance standards. Expertise in enterprise architecture, system integration, and process optimization. Deep understanding of financial management, supply chain, and other core ERP-supported business processes. Proficiency More ❯
collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of More ❯
collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of More ❯
Manchester, Lancashire, United Kingdom Hybrid / WFH Options
Azenta US, Inc
make a broad application of principles, theories, concepts, and techniques used in the applicable technical or business discipline and working knowledge of interrelated fields. Support validation of ISO/GxP regulations to ensure standards are achieved. Exercises judgment using generally defined practices and policies in selecting methods and techniques for arriving at solutions. Frequent inter-organizational and external customer contacts. More ❯
senior leadership roles aligning clinical system operations with business goals and driving innovation. Vast leadership experience in people management and large matrixed environments. Experience and vast working knowledge of GxP, CSV, data security, and IT infrastructure. Experience in leading organizational change initiatives, including the adoption of new technologies, process improvements, and system upgrades. Experience in and strong grasp of emerging More ❯
experience in sales and solutioning for Digital (Information) Technology or Computer Science management. Extensive client-facing experience and ability to engage at the C-suite level Preferred experience in GxP, life sciences and lab instrumentation services and technology, regulatory compliance standards and processes. Excellent written and verbal communication skills. Strong organizational and analytical skills. Ability to provide efficient, timely, reliable More ❯
solutions. The ideal candidate will have strong technical skills, as the point person accountable for designing and approving solutions, while ensuring compliance to validation activities in a heavily regulated GxP environment. A key function of this role is the ability to partner successfully with 3rd party vendors, system integrators, SaaS vendors and internal team leads to ensure appropriate integration of More ❯
digital technology market. Experience with SAP is required. Expertise in team dynamics, organizational and project management skills, balancing multiple complex projects with outstanding (senior) stakeholder engagement skills. Experience in GxP, privacy regulations, data integrity and (Agile) systems lifecycle development. Strong influencing skills, with the ability to understand issues from multiple viewpoints. A bias for transformational change, experience in change management More ❯
the pharmaceuticals industry. Strong experience in a Scrum Master role. Proven experience in both Agile and traditional project delivery environments. Excellent organizational, facilitation, and communication skills. Strong understanding of GxP (Good Practice) guidelines. More ❯
System Validation training desirable. Knowledge, Skills, and Abilities Proven experience working with ETQ, MasterControl, or similar eQMS platforms - configuration, administration, and user training. Strong working knowledge with CSV and GxP system implementations in a regulated pharmaceutical or life sciences environment. Hands-on experience with CSV activities relating to Empower CDS, including: Validation of new Empower installations and version upgrades Data More ❯
to work from home or in the office, so you can thrive in your ideal environment. Tired of working with old technology? Looking for an opportunity to change how GxP documents, quality processes, and regulatory compliance are managed in Life Sciences? Veeva's Vault Quality suite is the industry's only complete quality solution for managing quality processes with regulated More ❯
Pharmaceutical, Computer Science, IT, Engineering, or a related field. 10+ years of experience in Computer System Validation (CSV) in the pharmaceutical, biotech, or medical device industry. Strong knowledge of GxP, 21 CFR Part 11, GAMP 5, Data Integrity, and Annex 11. Experience in validating SaaS applications used in the pharmaceutical industry. Familiarity with Veeva Vault RIMS, QualityDocs, or Submissions Archive More ❯
For: Master's degree or PhD in Life Sciences, Behavioral or Educational Sciences, with expertise in training needs assessment and curriculum development. Minimum of 5 years' experience in a GxP-regulated environment, with solid knowledge of pharmaceutical operations and production methods. Strong background in Quality systems, Operational Excellence (OpEx), TPM, and HSE systems. Demonstrated ability to think strategically and manage More ❯
5+ years of customer-facing technical consulting experience Proven track record meeting with management and executives as the subject matter expert Experience with the Life Science Industry/with GxP and software validation regulations Experience leading and mentoring team members Ability to travel up to 20% Nice to Have Experience with Clinical, Regulatory, Quality, or Safety business processes Experience with More ❯
Hatfield, England, United Kingdom Hybrid / WFH Options
Cpl Life Sciences
a strong emphasis on stakeholder management and effective communication with senior managers and directors. What are we looking for? Experience delivering business changes or IT business system projects to GxP environment, either in a pharma site or equivalent a must have Demonstrated experience in IT Project Management. Demonstrated experience in stakeholder management and presenting to senior managers and directors. Experience More ❯
teams and external vendors Support installation/configuration of validated and non-validated systems Assist in patching, updates, and system maintenance Ensure adherence to validation standards such as CSV, GxP, and 21 CFR Part 11 Maintain accurate support records via the helpdesk system Provide onboarding and training to end users Identify and propose improvements in IT services and system performance More ❯
Stevenage, Hertfordshire, South East, United Kingdom
Infoplus Technologies UK Ltd
model and how to troubleshoot different network layers. Knowledge and understanding of Active Directory required. AGILE ways of working necessary. Background with computer security Previous experience with validated systems (GxP) a plus. Familiar with ticketing systems such as Service-Now a plus. Microsoft Excel skills a plus. Business Analyst experience would be a bonus Personal Skills: Must have outstanding communication More ❯
London, South East, England, United Kingdom Hybrid / WFH Options
Opus Recruitment Solutions Ltd
working with open-source bioinformatics tools and APIs Comfortable building end-to-end ML pipelines in cloud environments Familiarity with regulatory considerations in clinical or research settings (e.g., HIPAA, GxPMore ❯
with our AMS 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+ years … capabilities, with a demonstrated ability to translate complex business requirements into efficient, integrated SAP solutions. Industry Insight: Experience working within pharmaceutical, biotech, or similarly regulated manufacturing environments. Familiarity with GxP protocols, FDA regulatory compliance, ISO standards, and other pertinent quality assurance standards. Educational Background & Certifications: Bachelor's degree in Information Technology, Engineering, Business, or a related field. SAP certifications in More ❯
Are you an experienced ERP Project Manager with a strong background in GxP-compliant systems? We’re recruiting for a dynamic contract opportunity to lead a high-impact ERP implementation project within a regulated environment. As the ERP Project Manager, you’ll be responsible for overseeing the end-to-end delivery of a major ERP system implementation. This includes managing … timelines, budgets, stakeholders, and ensuring compliance with GxP standards throughout the project lifecycle. This position is offered outside IR35 on a day rate contract for 12 months. Key Responsibilities: Lead the planning and execution of ERP implementation projects Ensure alignment with GxP regulatory requirements and validation protocols Manage cross-functional teams including IT, QA, supply chain, and finance Develop and … third-party partners Drive stakeholder engagement and communication across all levels Experience Required: Proven track record of successfully delivering ERP projects (e.g., SAP, Oracle, NetSuite, etc.) Strong understanding of GxP compliance and validation in regulated industries (e.g., pharma, biotech, medical devices) Excellent project management skills with experience in Agile and/or Waterfall methodologies Exceptional communication and stakeholder management abilities More ❯
E-WorkBook software, IDBS has extended its flexible, scalable solutions to the IDBS Polar and PIMS cloud platforms to help scientists make smarter decisions with assured confidence in both GxP and non-GxP environments. Do you want to work in a dynamic, fast paced, high performing, safe to fail and fun environment which is founded on trust, empowerment and autonomy More ❯
IT, and quality teams to deliver robust compliance in a regulated environment. Key Responsibilities: Lead governance, risk, and compliance for SAP Finance & Non-Finance systems. Ensure adherence to SOX, GxP, GDPR, and related regulatory requirements. Oversee implementation and maintenance of IT Quality Management Systems (QMS). Provide governance oversight during SAP S/4HANA implementations, upgrades, and integrations. Review and … Collaborate with cross-functional teams to ensure alignment with corporate and regulatory frameworks. Skills, Experience, and Abilities Required: 10+ years' GRC experience in senior roles. Proven experience with SOX, GxP, GDPR, and QMS documentation. Strong SAP expertise minimum SAP, with S/4HANA preferred. Deep understanding of SAP roles, critical objects, and tables. Excellent stakeholder engagement and business analysis skills. More ❯
align with Orchard's strategic goals. The role focuses on process improvement, digital transformation, and cross-functional collaboration, ensuring seamless integration of ERP and patient orchestration platforms within a GxP-regulated environment. Key Responsibilities Business Process Optimization: Analyze, design, and improve SCM business processes across logistics, distribution, manufacturing, and warehousing. Lead process improvement projects, ensuring alignment with operational goals. Define … knowledge of SCM ERP modules (procurement, logistics, manufacturing, warehousing). Experience with patient orchestration platforms for Cell and Gene Therapy. Proficient in business process mapping, Lean Six Sigma, and GxP compliance. Familiar with IT and quality change control processes. Skills & Competencies: Certified Business Analysis Professional (CBAP) or equivalent preferred. Strong leadership, problem-solving, and project management skills. Excellent communication, organizational More ❯
E-WorkBook software, IDBS has extended its flexible, scalable solutions to the IDBS Polar and PIMS cloud platforms to help scientists make smarter decisions with assured confidence in both GxP and non-GxP environments. Do you want to work in a dynamic, fast paced, high performing, safe to fail and fun environment which is founded on trust, empowerment and autonomy … the technical implementation plan and backlog refinement. Provide technical perspective to products enhancements & new requirements activities. Optimize Spark-based workflows for performance, scalability, and data integrity, ensuring alignment with GxP and other regulatory standards. Research, and promote new technologies, design patterns, approaches, tools and methodologies that could optimise and accelerate development. Apply strong software engineering practices including version control (Git … pipelines that process clinical and pharmaceutical data efficiently, reducing data latency and improving time-to-insight for research and regulatory teams. Enabled regulatory compliance by implementing secure, auditable, and GxP-aligned data workflows with robust access controls. Improved system performance and cost-efficiency by optimizing Spark jobs and Databricks clusters, leading to measurable reductions in compute costs and processing times. More ❯