1 to 25 of 30 Remote GxP Jobs

data analysis. Laboratory Experience: Hands-on experience performing or supporting data capture from instruments in a research laboratory or vivarium. Regulatory knowledge: Experience handling GxP data and system validation. Knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP). Scientific Software Expertise : Experience using More ❯

adherence to biotech-specific regulatory frameworks such as Food and Drug Administration (FDA), Health Insurance Portability and Accountability Act (HIPAA), and Good x Practice (GxP). Drive initiatives for cost optimization, automation, and modernization of infrastructure services. Oversee disaster recovery (DR) and business continuity plans (BCP), ensuring strong preparedness and More ❯

at least 5 years of experience in a pharmaceutical or regulated QC environment 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 More ❯

best automation solutions. Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards. Build the business processes to support the project scope in alignment with project More ❯

documents, risk management plans, and post-project reviews. Ensure all projects comply with industry regulations, particularly those related to pharmacovigilance and data privacy (e.g. GxP, GDPR). Coordinate and manage interactions with third-party vendors, consultants, and partners to ensure successful delivery and integration of external components or services. Support More ❯

computer systems validation requirements Ability to travel approx 30-50% Nice to Have Understanding of Computer Systems Validation Understanding of Learning Management Systems and GxP training needs and regulations Understanding of LIMS Proven track record leading high-impact global system implementation programs as a consultant, business or IT lead, and More ❯

standards and performance across the Lilly enterprise. This role will support implementation of technology solutions that are simplified, sustainable, and compliant throughout Lilly's GxP operations. The Sr. Principal Associate partners with organizations globally to deploy the solutions to achieve quality operational excellence and drive quality culture. Key Objectives/ More ❯

Lilly enterprise. As part of the transformation, this role will support implementation of technology solutions that are simplified, sustainable, and compliant throughout Lilly's GxP operations across the enterprise. The Sr. Principle Associate partners with organizations globally to deploy and maintain the solutions to achieve quality operational excellence and drive More ❯

effective performance of the team/individuals. Understand and adhere to corporate standards regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance, data security, and the software development lifecycle. This role will require 3 days in the Mettawa office.Candidates who are not local or within a More ❯

/ML engineering in an industrial setting within a global organization (technology company preferred) Experience in working within compliance (e.g. quality, regulatory - data privacy, GxP, SOX) and knowledge cybersecurity is a plus Experience in production model monitoring (e.g., model drift detection) and responsible AI application development is a huge plus More ❯

multiple organizational units. Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Ability to anticipate, evaluate and resolve project issues, delays, and problems by using technical, project management, and business expertise. Manage multiple initiatives and priorities. More ❯

in accordance with software/system development life cycle principles; Contribute to computer systems validation activities as they relate to 21 CFR Part 11 & GxP compliance (e.g. user requirements gathering & definition, authoring of technical specification documents, authoring user acceptance tests); Analyze user feedback to identify and remediate issues with the More ❯

stakeholder interests through sound analysis and persuasion Understand and adhere to corporate standards regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance, data security, and the software development cycle Qualifications Bachelors Degree with 6 years experience; masters degree with 5 years experience; PhD with 0 years More ❯

wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance. Sound knowledge of current GxP Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts Some experience in Project Management Communication & Leadership Skills: Experience in More ❯

3+ years of experience in Life Sciences, Healthcare, or an adjacent Safety industry Experience implementing, supporting, or administrating core business/IT operations with GxP software solutions Good knowledge of implementation methodologies for SaaS solution Proven ability to deliver on time and with a high degree of satisfaction Longstanding passion More ❯

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/ More ❯

a story in a clear and concise manner to technical and non-technical audiences is required Experience operating in a regulated environment, e.g. SOX, GxP Firm grasp of industry, digital, and artificial intelligence trends and market conditions Skilled in agile product development and use of Jira, Confluence, Miro Experience using More ❯

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 More ❯

to 10% Nice to Have Experience in the pharmaceutical and life sciences industry Experience with Clinical, Regulatory, Quality, or Safety business processes Experience with GxP regulations and software validation process Document/Data migration experience Experience with source code control systems Amazon Web Services (AWS) tools such as Lambda and More ❯

technological or innovation field, Biomedical Engineering, or related field plus 10 years of related experience. Prior experience must include: Lead the design & delivery of GxP Digital Health products & solutions across R&D Global Drug Development business functions; Manage cross-functional collaboration across business, technical & vendor groups to successfully deliver & manage More ❯

improve existing products, services and tools. Complete all mandatory company-wide compliance training and job-specific training required for the role, including QMS, ISMS, GxP, DocuSign, SDLC as applicable. About You (Skills and Experience): A Bachelor's or higher in Computer Science, Information Systems or another related field is essential. More ❯

Risk & Compliance: Support operational technology compliance with internal security and risk management policies and practices, as well as external regulatory and statutory requirements e.g. GxP and that Tech continuity plans are in place for all critical areas. People Management: Collaborate with internal owners of security technologies such as antivirus, IDS More ❯

Identify areas for improvement in existing processes to enhance the efficiency and performance of data analysis. o Ensure IT systems comply with regulatory requirements (GxP, FDA 21 CFR Part 11, Eudralex Annex 11, etc.). o Participate in risk assessments and define validation strategies tailored to each system. o Train … propose appropriate solutions. o You have knowledges of data management tools (advanced Excel, Power BI, SQL or equivalent). o You are familiar with GxP standards, FDA 21 CFR Part 11, and/or EU Annex 11 guidelines. o You have experience or high affinity with computer/software area. … oriented, open-minded, and flexible. o Which can be seen as a plus: • You have proven experience in Computer System Validation (CSV) in a GxP context. • You have experience in Pharmaceutical Manufacturing, R&D or Quality Control Environment. • You are familiar with the use of laboratory softwares and/or More ❯

Chromatography Data Systems (CDS) Product Team and will be responsible for driving Life Cycle Management of Empower, Chromeleon, Unicorn and other CDS applications, including GxP validation, testing, and compliance activities, remediation of software vulnerabilities, and managing backup and disaster recovery plans for CDS applications. As the technical Product Owner, you … technologies and frameworks that can enhance the capabilities and performance of the software solutions. Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion Apply machine learning and Gen AI techniques to accelerate … Have Skills: Demonstrated experience of owning business applications in a Life Sciences, Pharmaceutical, Biotech company or equivalent industry or knowledge of the pharmaceutical industry GxP system qualification and validation processes for computer related systems Strong knowledge of COTS (Commercial-off-the-shelf) Validations on HPLCs, UPLCs, CEs, GCs, and other More ❯

platforms systems as well as custom software projects Experience with Mettler Toledo LabX Experience with Aveva OSIsoft PI Historian Knowledge of both project and GxP change control procedures incl. experience with change impact assessments Demonstrated leadership in deploying new software packages in GxP manufacturing environments EDUCATION B.S. in an Engineering More ❯