Associate Director, IT Gxp Systems

Associate Director, IT GxP Systems

The Associate Director, IT GxP Systems will work to maintain a stable GxP systems environment to enhance performance, uptime, and compliance. This person will implement IT GxP policies, procedures, and best practices and serve as the organization's Associate Director, IT GxP Systems.

This is an onsite position, with 4 days in the office and 1 day being remote.

Responsibilities

• Build and Own IT GxP Compliance program.

• Partner with IT and business leadership to select, plan, design, install, and validate GxP Systems in alignment with industry best practices (e.g., GAMP 5), established Quality Directives and SOPs.

• Oversee application lifecycles for enterprise GxP IT systems, collaborating with business partners, to ensure effective change control, testing, validation, and communication.

• Lead or support deviation/incident investigations related to corporate GxP information systems and manage the implementation of identified Corrective Actions / Preventive Actions (CAPA) resulting from these investigations.

• Develop execution plans for IT GxP policies and procedures, including those for architecture, security, backups, disaster recovery, data integrity standards.

• Partner with QA to manage systems validation, periodic reviews, and vendor coordination.

• Ensure regulatory compliance is aligned with industry best practices and standards.

• Maintains adherence of GxP functional and applications administration. This is to ensure IT systems, data and processes meet required service levels and adherence with policies and procedures for compliance.

• Manage the deployment, monitoring, maintenance, development, upgrade, and support of all GxP IT systems, including servers, PCs, operating systems, networks, hardware, network, software, and peripherals.

• Actively works with internal teams and external vendors and partners on qualification, audit of GxP systems.

• Benchmark, analyze, report on, and make recommendations for the improvement and growth of the IT GxP infrastructure and IT GxP systems.

Qualifications

• Bachelor's degree in computer science, engineering, or similar STEM concentration.

• 8+ years of application administration, development, design, configuration, release, validation, operations, governance, production, and support expertise within a complex pharma\biotechnology setting.

• Extensive hands-on application support experience for Clinical & Quality/Regulatory Systems in Life Sciences industry.

• Knowledge of Current Good Manufacturing Practice (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), GAMP5, 21 CFR part 11 and ICH.

• Prior hands-on experience with GxP Management, including oversight of Administration, Enhancements, and Operations.

• Adherence to corporate policies and procedures with a detailed understanding of GxP regulations.

• Knowledge of systems software, operations, capacity management, mid-range servers, PCs, SAAS, and web services. Must have hands on experience in qualifying production systems to meet regulatory requirements.

• Knowledge and expertise with Software as a Service (SaaS) systems, automated process equipment, and clinical data management software in the biotechnology or pharmaceutical industry.

• Experienced in gap analysis, remediation plans, and corrective and preventive action (CAPA), and in reviewing, modifying, and writing standard operating procedures (SOPs).

• Experience in System Administration, Change Management, Data Integrity, ALCOA+, 21 CFR Part 11.

• Strong technical knowledge of current network hardware, protocols, and standards.

• Strong understanding of project management principles.

• Extensive experience working in a team-oriented, collaborative environment.

• System Administration Certification for Veeva is NICE TO HAVE.

• Experience in representing IT to auditors.

The base pay range for this position at commencement of employment is expected to be between $175,000 and $205,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and Janssen scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.