1 to 25 of 65 GxP Jobs

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 Hands-on SAP functional consulting … problem-solving capabilities, with a demonstrated ability to translate complex business requirements into efficient, integrated SAP solutions. 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. Bachelor's degree in Information Technology, Engineering, Business, or a related field. SAP certifications in PP, QM, or More ❯

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 Hands-on SAP functional consulting … problem-solving capabilities, with a demonstrated ability to translate complex business requirements into efficient, integrated SAP solutions. 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. Bachelor's degree in Information Technology, Engineering, Business, or a related field. SAP certifications in PP, QM, or More ❯

have strong experience in cleaning, process equipements. You have at least 5 years of experience in a pharmaceutical with a focus on delivering solution. You have excellent understanding of GxP regulations, 21 CFR Part 11, Eudralex Annex 11 or other international requirements. You are proficiency in French and English, both written and spoken. You have proven experience as Project and More ❯

of scientific computing software and frameworks Previous experience in biotech or pharmaceutical industries Experience with cloud platforms (AWS, Azure) ITIL certification Security certifications (CISSP, CISM, or similar) Experience with GxP compliance Experience with pharmaceutical industry regulations Previous experience managing technical debt in regulated environments AskBio Inc . click apply for full job details More ❯

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 ❯

strategies to meet stakeholder expectations. Key Accountabilities Strategic Partnership & Stakeholder Engagement: Build strong relationships across all levels; understand business needs; align IT strategy and solutions with company goals, compliance (GxP), and innovation opportunities. SAP S/4HANA Implementation & Project Management: Lead requirement gathering, support configuration/testing, bridge business and technical teams; manage project timelines and drive adoption of new … in a regulated industry. Broad IT technical understanding with troubleshooting skills. Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Project management and organisational skills. Awareness of GxP regulations and system validation. Financial acumen and budgeting skills. Demonstrable SAP S/4HANA knowledge. Familiarity with Prince2 & Agile methodologies (desirable). Good understanding of change management best practices (desirable More ❯

10+ years SAP integration experience with 3+ years hands-on SAP Integration Suite and S/4HANA integration patterns •? 5+ years life sciences industry experience with deep understanding of GxP regulations, FDA 21 CFR Part 11 compliance, and validation methodologies •? Design and develop complex integration flows connecting S/4HANA with LIMS, MES, QMS, and regulatory reporting systems using REST 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 ❯

and third-party partners, ensuring high-quality delivery and strong stakeholder engagement throughout the project lifecycle. Key Responsibilities Lead the delivery of IT and business system projects, particularly in GxP-regulated environments. Define project objectives, manage resources, and oversee execution to ensure successful outcomes. Collaborate with internal stakeholders and external consultants to meet project goals. Maintain clear and effective communication … Monday.com, JIRA, or Trello. What We’re Looking For Degree or equivalent qualification. Project Management certification (e.g., PRINCE2, PMP, Agile, Scrum Master). Proven experience managing IT projects in GxP or similarly regulated environments. Strong stakeholder management and communication skills. Familiarity with PMO governance and project delivery frameworks. Experience in pharmaceuticals, healthcare, aerospace, or energy sectors is a plus. What More ❯

and transforming lives. Role Objectives: The WEP Clinical Global Third-Party and Audit Manager is responsible for the qualification, oversight, and auditing of third-party suppliers and vendors supporting GxP activities, including pharmaceutical manufacturing, distribution, and clinical operations. This includes providers across GMP, GDP, GCP, GLP, and GVP domains. The role ensures partners meet regulatory requirements and internal standards to … framework through risk-based oversight and cross-functional collaboration. The Ideal Candidate: Analytical Collaborative Adaptable Proactive What You'll Do: Own and lead global compliance monitoring programs for all GxP third parties, ensuring timely qualification, requalification, or disqualification. Design and manage a global, risk-based GxP audit program covering GMP, GDP, GCP, GLP, and GVP audits, both remote and on … on CAPA completion. Maintain and assess approved supplier and vendor lists, including criticality ratings and compliance status. Ensure all qualification and requalification activities align with EU, UK, and FDA GxP expectations and internal SOPs. Monitor ongoing third-party performance using audits, KPIs, deviations, complaints, and quality metrics. Lead risk-based internal audit programs and delegate audits to appropriately qualified personnel. More ❯

root cause analysis and CAPA Promote a collaborative, quality-focused project culture through cross-functional engagement CSV Analyst - Requirements : Minimum of 3 years' experience in SAP validation within regulated (GxP) environments Strong understanding of CSV frameworks and regulatory requirements (GxP, FDA, EMA, GAMP 5) Familiarity with pharmaceutical manufacturing processes and SAP QM (Quality Management) modules Demonstrated expertise in authoring and 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. Preferably prior experience with project management. More ❯

alsohad: An active membership in aprofessional body. Experience using Siemens TIA Portal. Knowledge of IEC 61131 - 3 programming languages. Knowledge and experience of applying a GAMP 5 approach to GxP Computerised System Validation. Knowledge of functional safety systems within automated machinery. Chartered/registered status with arelevant professional institution. Have industrial experience within a GMP environment. What does CPI offeryou More ❯

OT security documentation. Assist in adjusting documents of OT firewalls and network security zones. Document security enhancements aligned with IEC 62443, NIST, and cybersecurity frameworks. Ensure procedural compliance across GxP and non-GxP environments. Coordinate with stakeholders to document OT security initiatives. Requirements: 5+ years of experience in OT Security project engineer roles. Bachelor's degree or higher in Cybersecurity … Cisco ASA). Understanding of OT protocols (Modbus, OPC UA, DNP3) and control systems (PLC, SCADA). Good understanding of compliance frameworks such as IEC 62443, ISO 27001, and GxP requirements. Experience in regulated manufacturing environments (pharma, biotech, etc.) Ability to work remotely with stakeholders across Europe or the US. Strong interpersonal skills. Fluent in English (written and spoken). More ❯

support regulated pharma environments, manage internal and external audits, and influence the company's quality strategy in collaboration with technical and customer-facing teams. If you are experienced in GxP, ISO, and EU regulatory frameworks, this is your opportunity to make a lasting impact in a high-growth, innovation-focused environment. Accountabilities: Maintain compliance across products and operations, particularly focusing … on EU regulations such as GxP, ISO 9001, and Annex 11. Work closely with Product, Engineering, Quality, and Customer Success teams to ensure the platform meets customer validation and compliance needs. Own and enhance the GxP Package to support clients in achieving faster regulatory approvals and validations. Lead internal audits and prepare the organization for external assessments (e.g., ISO … functional 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-functional collaboration skills. Proven More ❯

integration teams to ensure accurate implementation. Support ERP project delivery, including workshops, UAT, training, change management, and golive support. Collaborate with compliance and validation teams to ensure solutions meet GxP and audit requirements Required Skills & Experience Demonstrated track record in business analysis, with a strong focus on ERP systems— particularly Microsoft Dynamics 365 Finance & Operations (D365 F&O). Proven … expertise in Supply Chain and Manufacturing modules (inventory, procurement, production, demand planning). Experience in the pharmaceutical industry or a similarly regulated, GxP-compliant environment. Strong understanding of ERP best practices, master data management, and process transformation in global organizations. Skilled in gathering requirements, facilitating workshops, and producing high-quality documentation. Strong stakeholder management and communication skills across technical and More ❯

documentation Strong analytical and problem-solving skills Excellent communication and collaboration abilities Preferred Qualifications: Bachelor's degree in Computer Science, Information Technology, Engineering, or a related field Knowledge of GxP, 21 CFR Part 11, and industry-specific validation regulations Familiarity with validation tools and methodologies Interested? Send your CV to to discuss further More ❯

of Claims, DAM (Digital Asset Management), Modular Content, MLR review, and European regulatory requirements (e.g., ABPI, ANSM, AIFA) Understanding of life sciences compliance and computer systems validation requirements (e.g., GxP, GcP) Project management certification (e.g,. PRINCE2, PMP) Experience with product pre-sales, solution consulting, or engagement management Fluency in Italian, French, or German SaaS/Cloud experience Veeva's More ❯

with pharma production, engineering and relevant business stakeholders to deploy IT systems to a pharma manufacturing site Experience deploying and managing life cycle of an MES solution in an GxP environment with experience in Tulip platform an advantage Good knowledge blend of pharmaceutical manufacturing business and business processes and IT system components Knowledge of deviation management, change control management & computer … system validation in GxP environment Team leadership experience Advantage: Experience of application management & configuration management in ServiceNow Experience of general IT system lifecycle management Project management More ❯

Pharmaceutical manufacturing environments. About the Role: As an IS Support Analyst, you'll act as a vital link between the IT Helpdesk and end users working in highly regulated GxP environments. You will troubleshoot issues, maintain system integrity, and ensure minimal downtime of business-critical and validated systems. This role is key to supporting seamless operations in both laboratory and … and specialized 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 to enhance … and communication skills. Ability to prioritise tasks and manage time effectively under pressure. Desirable Experience: Previous experience working in pharmaceutical, biotech, or laboratory settings. Familiarity with validated systems and GxP environments. This is an excellent opportunity to join a collaborative, compliance-focused environment and make a meaningful impact supporting essential IT systems. If you're ready to bring your skills More ❯

validation procedures. You will stay informed on the latest regulatory requirements and support the IT department in Software and Hardware Validation compliance. As a subject matter expert (SME) for GxP systems, you will drive compliance strategies and manage GxP system life cycle activities, including change management and system integration projects. Who You Are: Bachelor's/Undergraduate Degree in a More ❯

General MasterControl administrative tasks are completed contemporaneously e.g. users are provided with access when applicable, documents are reviewed and approved in a timely manner to facilitate the progression of GxP activities All users are appropriately trained and supported when using the MasterControl Software. Documentation maintained outside of the MasterControl system is maintained in an easily retrievable state Any records overdue … limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state Job Background Minimum of 3 years experience working in a GxP environment IT literate, experience managing and operating an electronic QMS English language required Why us More ❯

effective communication with senior managers and directors. Project Management certification (e.g., PRINCE2, PMI PMP, Agile, Scrum Master) or equivalent. 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. More ❯

supply, demand, PPDS, inventory) Troubleshoot daily planning issues and drive root-cause resolution Deliver RICEFW objects and functional documentation Support testing, training, and go-live activities Ensure compliance with GxP and SOX requirements Required Experience: 10+ years in SAP supply chain planning, including S/4 ePPDS and IBP Deep knowledge of IBP modules: Response & Supply, Inventory, S&OP, Control 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 ❯