The Position 

The purpose of this position within the Quality and Compliance department is to provide compliance oversight of GxP computer systems and validation.  A key function of the position will set the strategy and oversee Arrowhead approach to data integrity, data governance and computer systems validation.  

This position will report to the Vice President Quality and Compliance and work closely with members of the Information Technology and Systems, Quality, and Business Partners to promote awareness and understanding of CSV/CSA framework and controls with 21 CFR Part 11 / Annex 11, GAMP requirements and company’s goals.

Responsibilities 

• Serve as an internal subject matter expert in the field of CSV/CSA and 21 CFR Part11/Annex 11 /GAMPfor GxP regulated industry and advise internal stakeholders and management on matters related to regulatory compliance and R&D electronic data integrity
• Collaborate with business partners to ensure continuous and verifiable compliance and data integrity throughout the entire information systems ecosphere and lifecycle
• Coordinate Quality input in the development and revision of GxP computer system procedures, change control, investigations and CAPAs related to the computerized systems.
• Assess and ensure overall readiness of the CSV/CSA program and computer-related systems readiness for audits and regulatory inspections
• Work in collaboration with the ISI and system owners to prioritize, develop and implement necessary risk assessments and mitigation actions, aligned with evolving regulatory requirements, industry standards, and business initiatives and strategies through the system lifecycle -implementation, maintenance, change management, and decommissioning
• Coordinate Quality review and approval of validation strategy, plans, protocols, reports and other verification/validation related documentation for GxP computer systems
• Collaborate with ISI and business partners on development of robust policies and other guidance documents to ensure compliance with applicable laws and regulations, and industry standards
• Proactively drive culture of compliance by drafting and disseminating written materials and training that are aimed at increasing stakeholders’ awareness and understating of relevant regulatory requirements and industry standards.
• Prepare and present periodic reports and status of compliance to management, including the measures and activities to ensure compliance.
• Effectively manage priorities, multiple projects and ability to communicate with all levels of personnel
• Other duties as assigned

Requirements:

• At least 10 years of relevant experience
• Experience leading QA CSV in the pharmaceutical industry and quality organization
• Experience in EDMS, LMS, e-QMS and ERP implementation and lifecycle management
• Experience as an effective collaborator and leader
• Experience creating policies and procedures focused on data integrity and computer systems validation
• Experience creating and presenting project plans, trainings and other presentations for leadership
• Strong knowledge of 21CFRPart 11/Annex 11/GAMP regulations, associated guidances, and standards
• Competent knowledge of Microsoft Office, EDMS, eQMS, LMS, ERP suites

Preferred: 

• BS or Masters’ degree in relevant area