Associate Director, Global Quality Compliance & Computer Systems
Scorpion Therapeutics, Parsippany, New Jersey, United States
Role Summary
Associate Director, Global Quality Compliance & Computer Systems is responsible for oversight, accountability, and associated activities for the Veeva Global GxP Quality Management / Electronic Document Management System (QMS/EDMS) program and other assigned Global Quality computer systems as a PMO lead. Location: Parsippany, NJ (hybrid role, 3 days onsite). This is a temporary assignment planned to go through 2028. Responsibilities
Manage defined implementation project schedule and activities related to the Veeva Global GxP program, including oversight for global and site communication plans, prioritization of key activities, issue escalation, and risk mitigation. Partner with Business and IT to resolve issues. Direct activities and priorities for external contractors assigned to the Veeva Global GxP program (e.g., Deployment Leads, Change Management and Training Lead). Support overall Teva Quality team with daily operational activities (e.g., meetings, trainings). Develop and implement guidance and templates to enhance business program management activities. Support business workstreams for the Veeva project, including:
Participate in design review sessions, document open questions, address follow-ups. Provide support to project SMEs during process reviews and testing activities. Assist with creation/review of work instructions, procedures, and training modules for the business workstream. Work with IT teams and support Deployment Leads with deployment and migration activities.
Provide updates in program and Quality Global/regional/leadership meetings. Serve as backup to the Head of Global Quality Computer Systems as assigned. Additional activities as assigned. Qualifications
Required: Bachelor’s in Science; advanced degree in science/regulatory/computer science/management preferred. Required: Minimum of 8 years in pharmaceutical or related industry. Required: In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices. Required: Knowledge of cGxP requirements, quality-related IT applications, and computer system validation. Required: Minimum 5 years of experience in project/program management leading complex GxP projects including implementation/deployment and data migration in the pharmaceutical industry. Required: Demonstrates resourcefulness and initiative; creates appropriate urgency to meet objectives and deadlines. Required: Experience in large, multinational companies leading cross-functional teams. Preferred: Prior experience with Veeva Quality Vault. Required: Excellent communication skills; English fluency; proficiency in MS Office tools including MS Project. Skills
Project/program management Veeva Quality Vault familiarity (preferred) Cross-functional leadership Communication and stakeholder management Process design and documentation Education
Bachelor of Science required; advanced degree preferred in science/regulatory/computer science/management.
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Associate Director, Global Quality Compliance & Computer Systems is responsible for oversight, accountability, and associated activities for the Veeva Global GxP Quality Management / Electronic Document Management System (QMS/EDMS) program and other assigned Global Quality computer systems as a PMO lead. Location: Parsippany, NJ (hybrid role, 3 days onsite). This is a temporary assignment planned to go through 2028. Responsibilities
Manage defined implementation project schedule and activities related to the Veeva Global GxP program, including oversight for global and site communication plans, prioritization of key activities, issue escalation, and risk mitigation. Partner with Business and IT to resolve issues. Direct activities and priorities for external contractors assigned to the Veeva Global GxP program (e.g., Deployment Leads, Change Management and Training Lead). Support overall Teva Quality team with daily operational activities (e.g., meetings, trainings). Develop and implement guidance and templates to enhance business program management activities. Support business workstreams for the Veeva project, including:
Participate in design review sessions, document open questions, address follow-ups. Provide support to project SMEs during process reviews and testing activities. Assist with creation/review of work instructions, procedures, and training modules for the business workstream. Work with IT teams and support Deployment Leads with deployment and migration activities.
Provide updates in program and Quality Global/regional/leadership meetings. Serve as backup to the Head of Global Quality Computer Systems as assigned. Additional activities as assigned. Qualifications
Required: Bachelor’s in Science; advanced degree in science/regulatory/computer science/management preferred. Required: Minimum of 8 years in pharmaceutical or related industry. Required: In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices. Required: Knowledge of cGxP requirements, quality-related IT applications, and computer system validation. Required: Minimum 5 years of experience in project/program management leading complex GxP projects including implementation/deployment and data migration in the pharmaceutical industry. Required: Demonstrates resourcefulness and initiative; creates appropriate urgency to meet objectives and deadlines. Required: Experience in large, multinational companies leading cross-functional teams. Preferred: Prior experience with Veeva Quality Vault. Required: Excellent communication skills; English fluency; proficiency in MS Office tools including MS Project. Skills
Project/program management Veeva Quality Vault familiarity (preferred) Cross-functional leadership Communication and stakeholder management Process design and documentation Education
Bachelor of Science required; advanced degree preferred in science/regulatory/computer science/management.
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