CSV Lead

JOB DESCRIPTION    

We are a mid-sized BioPharma organization looking for a Computer Systems Validation specialist with:

·        A minimum of 10 years hands on CSV experience that is an expert in assuring compliant computer systems throughout the software development lifecycle, validation, maintenance, and decommissioning.

·        Hands on skills and experience of data migration planning, testing and reporting.

·        Strong working knowledge of data integrity requirements, controls, execution, evidence and reporting.

·        Comfortable and knowledgeable in the execution of infrastructure qualification.

·        A minimum of 10 years supporting regulatory inspections such as FDA, EMA inspections

·        Experienced in leading CSV approaches for individual projects.

·        Experienced in leading technical conversations re the CSV approach and content for specific validation deliverables.

·        Educating and mentoring IT staff with minimal GxP knowledge and experience.

The Role:

·        To own and lead CSV thinking and specific execution approaches in all software areas, ERP, data warehousing, laboratories and manufacturing areas.

·        To own and lead CSV CoE, (Centre of Excellence) and CoP (Community of Practice). The purpose of these forums being:

o   CoE: Deliver and maintain a world class QMS for CSV & Data Integrity. Policies, Standards, SOP, templates, risk-based approach, CSA, etc.

o   CoP: Create and maintain a world class team of various SMEs that use or rely on CSV practices, educating and supporting CoP team members from the CIO to the Lab SME or manufacturing supervisor.

·        Provide CSV SME leadership as required to project implementation teams or IT staff maintaining GxP applications.

·        Develop and build compliance framework and dashboard to proactively monitor compliance and act as required to assure compliance.

Role Details:

o   Frequent visit to sites shall be required.

o   Reports to Director of CSV and QMS.

o   Technical leadership role requiring strong general GMP and QMS knowledge.

o   Supporting CSV projects, communication and building of teams will be primary aspects of the role.

Required Skillset   

•   CSV Expert 10 years 

Proven Technical Leadership Skills

•   Recent Biopharmaceutical Industry Experience

•   FDA / EMA Inspection Readiness