CSV Team Lead Position Available In Chester, Pennsylvania

CSV Team Lead
US – Malvern, United States

JOB DESCRIPTION

Responsibilities Lead the global CSV team, providing guidance, training, and support to ensure the successful execution of validation activities.
Provides IT CSV oversight for GXP computerized systems and risk-based applications to validation/qualification efforts in compliance with 21 CFR Part 11, GMP Annex 11, OECD 17 and GAMP 5.
Provides IT CSV oversight of deviations, CAPAs, and change controls related to GXP computerized systems.
Review and create validation documentation – such as user requirements functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments and traceability matrices, and validation summary reports.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure the successful validation of computer systems and software applications.
Effectively identifies and resolves system issues and appropriately communicates gating items to senior management and stakeholders.
Supports the external audit program for vendors related to GXP computerized systems.
May support and interface with regulatory agencies as required in support of regulatory agency inspections.
Develop and implement CSV strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g., FDA, MHRA, NMPA and TGA).
Review and approve validation documentation, ensuring accuracy, completeness, and compliance with regulatory requirements.
Effectively resource, coordinate, monitor and track validation activities to ensure timely completion and adherence to project timelines.
Stay current with industry trends, regulatory changes, and best practices related to CSV.
Provide support during regulatory inspections and audits, including presenting validation strategies and justification of risk-based decisions taken. Continuously improving the CSV process by identifying areas for enhancement and implementing best practices.
Skills, Education & Qualifications
Direct experience of leading or managing CSV projects in GxP environments.
GLP/GCP experience necessary. GMP experience preferable.
Experience supporting regulatory inspections.
B.S. degree in Computer Science, Chemistry or relevant scientific field with substantial relevant progressive experience, within the pharmaceutical/biotech industry.
Extensive experience in federally regulated industries or CSV teams in Pharmaceutical / Biotech industry with comprehensive expertise and working knowledge of GxP, 21 CFR Part 11, OECD 17, and GMP Annex 11 compliance requirements.

ABOUT US

Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.
We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.
If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.

JOB INFO

Job Identification
289
Posting Date
06/17/2025, 12:11 PM
Job Schedule
Full time
Locations
17 Lee Blvd, MALVERN, US