SUMMARY DESCRIPTION

This position reports to the Manager, QA CSV and will be responsible for QA oversight of computer system validation (CSV) activities. This position will not have direct reports. Duties will include planning, organizing, QA oversight of CSV program development; validation of new computerized systems, and validation of upgrades/modifications to existing computerized systems. The position organizes and performs QA oversight of validation activities. Position will oversee validation in support of cGMP compliance and regulatory filings. Position will also interact with regulatory agencies and corporate partners during inspections and audits. May require minor travel for auditing vendors.

CSV oversight separated into two types:
1 IT based enterprise systems (LIMS, ERP, MES, CMMS, etc.).
2 Equipment based systems; these may be instruments that are PC based, SCADAs, PLCs, PCs etc.

The QA CSV role is dependant on the type of system being addressed.
Type 1 systems: QA CSV provides oversight for the IT CSV effort. This includes review and approval of various validation related documents.
Type 2 systems: QA CSV is responsible for the generation and execution of validation documents, as well as providing the QA oversight role.

RESPONSIBILITIES

• Represent QA on computer system related project team; primary responsibility is to ensure appropriate quality management procedures, measures, and activities are planned for and executed by the project team.
• Direct and assist in the development of Risk Management Plans and Risk Assessments as they relate to computer system validation projects.
• Work closely with Information Technology department and system owners to effectively and efficiently implement new systems, system upgrades, or system modifications.
• Develop validation master plans for type 2 computerized systems.
• Assist in development, implementation, and enforcement of computer validation policies and practices.
• Design validation studies for new systems, system modifications, and system upgrades, including writing and executing validation protocols and authoring final reports.
• Review and approve computerized system related documents.
• Coordinate validation studies through vendors
• Coordinate implementation projects and validation studies with internal departments.
• Assist in audits of computerized system vendors.
• Presentation of validation reports to state, federal, and international regulatory agencies.
• Assist in the development, analysis, and management of the annual budget for internal and external resources and expenses
• Participate in inspection preparation, train employees in inspection requirements and participate in regulatory inspections, defending validation functions and studies
• Support regulatory filings for all drug products
• Maintain current knowledge of industry standards and regulatory requirements for systems utilized by BioMarin for development, manufacturing, testing, release, clinical, and quality system activities related to BioMarin products.
• Represent Validation in multi-departmental meetings & project teams
• Strive toward constant improvement of validation systems in order to maintain compliance cGMP requirements for work performed
• Other duties as assigned

EDUCATION

Minimum BS in a technical discipline (computer science or engineering discipline preferred but not required). Equivalent experience may be considered.

EXPERIENCE

• 7+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency of industry standards for computerized system design, implementation, and validation.
• Organizational and management skills to coordinate multi-discipline project groups, with ability to effectively delegate work. Formal project management experience is desired, PMP or other certification is a plus.
• Knowledge and practical understanding of quantitative and qualitative risk assessment methodologies and their application to computer system validation activities.
• Ability to speak, present data, and defend approaches in front of audiences and inspectors.
• Ability to comprehend technical information related to equipment, controllers (PLC, micro-processor-based, SCADA, etc), computer software (operating systems, software applications), computer and network hardware, and the associated regulatory expectations relating to them.
• Knowledgeable in IT infrastructure and network qualifications. Practical knowledge of enterprise infrastructure required; NAS/SAN, TCP/IP, SSO/LDAP/NTLM, Backup and Recovery, Disaster Recovery. Knowledge and practical understanding of IT service management frameworks a plus (ITIL, COBIT, etc.)
• Ability to perform source code review is desired but not required.
• Experience and practical understanding of the development and validation of custom GAMP category 5 software, modules, interfaces, and reports is desired.
• Experience and proficiency with implementation of ERP, MES, MRP, LIMS, Trackwise, SQL Server, Oracle, LIMS applications, and eDMS applications is desired
• Practical understanding of GAMP and ERES standards and guidance.
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations. (Understanding of regulatory guidelines for other countries a plus), CFR 21 Part 11.
• Experience in participation in regulatory inspections, with experience in presenting or defending departmental functions in audits or regulatory inspections preferred, but not required