Senior Manager, Computer System Validation
Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20290-AB1
Compensation : 130000.00 - 170000.00 USD/YEAR
Start Date : 09/01/2020
Hours : Full Time
Required Years of Experience : 8
Required Education : BS Science or Engineering
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for Senior Manager for Computer Systems Validation (CSV), for review and approval of system QA validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices.
- Oversee all GxP computerized system implementation projects for the company to ensure compliance with regulatory requirements.
- Work with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and improving the effectiveness of the computer system validation and data integrity program.
- Serve as SME providing guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements.
- Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
- Work closely and collaboratively with various business partners including IT and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications.
- Review and QA approve various types of system validation and infrastructure qualification documentation, including Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports.
- Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes.
- Perform gap analysis of validation documentation, systems and practices. Recommending and implementing corrective actions and improvements.
- Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes.
- Support internal, client, and regulatory audits and inspections.
- Generate, review and update computer system related policies, procedures, templates, forms, etc.
Required Qualifications :
- BS Science or Engineering
- Minimum 8 years experience of pharmaceutical / biotech manufacturing computerized system compliance/validation/qualification activities.
- Must have experience in implementation of Quality systems.
- Expertise in 21 CFR Part 11 to ensuring site compliance.
- Comprehensive knowledge in Software Validation and Data Integrity Principles.
- Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations.
- Expertise in Software validation practices and Software Development Life Cycle (SDLC) models.
- Working knowledge of Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.
- Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)
- Knowledge of Software Risk Management Principles, methodologies and tools.
- Comprehensive knowledge of GAMP5, 21 CFR Part 11, EU Annex 11, FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, and Eudralex Vol 4.
- Experience with application system validation and infrastructure qualification.
- Experience with vendor audit for computer systems (IT infrastructure, validation etc.) is preferred.
- Experience with writing and approving Standard Operating Procedures and Quality Standards.
- Requires about 10% travel.
Contact: Allan Berman