Manager, Computer System Validation (CSV)

Summary of Job:

The Manager of CSV will have responsibility for the management and compliance oversight of all GxP regulated computerized system validation activities within the scope of services provided to RegDev clients and internal GxP systems. He/she will be responsible for developing, implementing and maintaining CSV methodologies to ensure the CSV process is effective and in compliance with necessary regulations.  Coordinate with QA and Validation Managers and guide them on all appropriate levels of validation activities required, ensure they are performed and following best practices in alignment with regulation.  In addition, he or she will work closely with his/her counterpart in the GCP Quality area in the implementation of Inspection Readiness programs.

 Essential Duties and Responsibilities:

• Serve as the RegDev subject matter expert around CSV, 21 CFR Part11, Annex 11, and GAMP for all GxP regulated matters.
• Conduct 21 CFR Part 11 / CSV / Data Integrity / Data Governance Gap Assessments and Audits.
• Develop and grow the CSV department, establishing effective services for our clients and systems and procedures which are effective.
• Effectively schedule and project manage CSV activities with RegDev client’s internal and external teams to ensure validation priorities and timelines are met.  Act as a CSV lead for validation projects and be hands on as required.
• Develop validation plans, qualification protocols, traceability Review and approve qualification protocols and summary reports.
• Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specifications, Risk Assessments, Installation/Operational Qualifications, UAT Protocols, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Data Integrity among others.
• Execute and/or oversee the execution of validation plans and validation documents.
• Oversee and manage CSV vendors, team members, and consultants.
• Responsible for planning, organizing and providing regular updates regarding validation activities cross-functionally both internally and externally for clients.
• Must be able to evaluate System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, propose recommended validation activities and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs), protocols, and plans.
• Responsible for creating, reviewing, and updating SOPs, forms, templates, documentation, and files as needed.
• Coach project teams on effective CSV activities, identify areas for improvement, implement a continuous improvement system.  

Job Requirements:

        Education:  Bachelors degree preferably in life science, computer science, or engineering

        Experience:    

• 7+ or more years of CSV experience within the life sciences and/or regulated industry (biotechnology, pharmaceutical).
• 3+ years of direct management of validation full-time staff and/or consultants.
• Experience developing and maintaining Quality Systems for a development and commercial organization.
• Strong knowledge, understanding and experience of process development within the biotechnology and/or pharmaceutical industry.
• Strong knowledge and experience implementing and maintaining EDMS, LMS, e-QMS, and ERP solutions.
• Strong knowledge and experience of 21 CFR Part 11, Annex 11, GAMP, and associated guidance and standard from FDA and other global industry regulations.
• Working knowledge and experience in Microsoft Office, EDMS, eQMS, LMS, and ERP suites.

Other Skills and Abilities:

• Must have an in depth understanding of quality systems requirements and have a proven track record for successfully implementing these requirements.
• Strong leadership, interpersonal, communication and team building skills.
• Excellent project management skills including the ability to interact effectively with internal team and manage vendor/partners to produce effective results.
• Ability to multi-task and good adaptability to changing business requirements in a dynamic corporate environment.
• Proven ability to coach, motivate and develop staff as well as create opportunities to leverage talent to meet business objectives.
• Prefers to work in a fast paced, smaller service company environment managing multiple client projects.

ADA Notations:

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
• Regular communication (hearing/speaking).
• Approximately 10% domestic travel may be required; overnight travel required as needed.
• Lifting up to 25 lbs.
• Routine home and onsite office duties including computer keyboard use.
• Vision requirements include close vision and ability to focus.
• Noise conditions range from quiet to moderate – home office conditions variable.

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