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Job Description: You will play a pivotal role in shaping and delivering high impact LIMS and CSV solutions for global life sciences and pharmaceutical clients Leveraging your deep expertise in GxP environments you will guide customers through their digital quality and laboratory transformation journeys ensuring systems are compliant efficient and future ready In this role you will collaborate closely with cross functional teams business stakeholders QA IT and vendors to design robust solutions that align with regulatory expectations and business goals As a senior member of the team you will mentor consultants drive best practices and bring structure and clarity to complex projects You will have the opportunity to influence strategy standardize methodologies and contribute to reusable frameworks and accelerators If you enjoy solving complex problems leading from the front and creating tangible value in regulated environments this role offers a platform to make a meaningful impact while working in a collaborative supportive culture Key Responsibilities: LIMS CSV Solution Leadership Lead end to end implementation enhancement and support of LIMS solutions for pharma biotech clients Define and execute Computer System Validation CSV strategies including validation plans test strategies and traceability matrices Ensure all LIMS and related systems are implemented in alignment with GxP 21 CFR Part 11 Annex 11 and relevant regulatory expectations Conduct impact assessments and risk based validation for system changes upgrades and new deployments Requirements Design Stakeholder Management Engage with business stakeholders to gather analyze and document requirements for laboratory and quality processes Translate business needs into functional and technical specifications for LIMS and associated systems Facilitate workshops walkthroughs and design sessions with cross functional teams and client SMEs Act as primary point of contact for client stakeholders managing expectations scope and priorities Project Delivery Management Plan track and manage LIMS CSV project activities timelines and deliverables in line with project management best practices Coordinate with internal teams vendors and client IT QA teams to ensure smooth execution and on time delivery Identify project risks and issues propose mitigation plans and drive resolution Ensure high quality documentation and adherence to SDLC and validation lifecycle processes Compliance Quality Governance Establish and maintain validation documentation URS FS DS IQ OQ PQ SOPs work instructions Support internal and external audits inspections and regulatory reviews related to LIMS and computerized systems Promote and enforce compliance with GxP data integrity and quality standards across project teams Drive continuous improvement in validation and compliance practices templates and methodologies Leadership Mentoring Best Practices Mentor and guide junior consultants and team members in LIMS CSV and GxP practices Contribute to building internal accelerators frameworks and reusable assets for LIMS and CSV projects Champion knowledge sharing training sessions and communities of practice within the organization Provide thought leadership on emerging trends in lab informatics validation and regulatory expectations Technical Requirements: Graduation in Life Sciences Pharmacy Biotechnology Chemistry Computer Science Engineering or a related discipline 9 18 years of total experience with substantial hands on exposure to LIMS implementations in regulated environments Strong demonstrable experience in Computer System Validation CSV across the full validation lifecycle Proven experience working in GxP compliant environments e g GMP GLP GCP with clear understanding of data integrity principles Ability to create and review key validation deliverables URS FS DS IQ OQ PQ test scripts traceability matrices Experience collaborating with business QA and IT stakeholders on system design testing and deployment Solid communication skills with the ability to explain complex regulatory and technical concepts to non technical stakeholders Preferred Skills: Domain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV),Foundational->Project_Management->PMP,Technology->Life Sciences->LIMS
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