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
