Regulatory and Quality Application Support Services Manager (Durban North) at Aspen Pharma Group

JOB PURPOSE:

• Operational role within the Group Digital Technology team responsible for the administration, configuration, and expert-level support of business applications across Regulatory, Quality, and Clinical domains. Some of the Regulatory Applications to include Veeva, Esko, Track wise Digital, TVT, and potentially any other regulatory application/s that Aspen may decide in investing in. The role ensures system stability, regulatory compliance, optimal platform performance, and high-quality service delivery. Additionally, the role contributes to licensing lifecycle support, financial recharge inputs for business units, mentoring junior team members, and cross-functional support in the Argus Pharmacovigilance (PV) environment. This role requires strong technical acumen, adherence to validated system processes, problem-solving skills, and the ability to collaborate across functional and business teams.

KEY PERFORMANCE AREAS:

Technical Responsibilities (Veeva Vault)

• Configure, maintain, and troubleshoot Veeva Vault applications across Regulatory, Quality, and Clinical domains.
• Act as SME for Vault configurations, workflows, lifecycles, roles, permissions, and integrations.
• Manage release cycles, participate in impact assessments, and execute testing activities.
• Support the rollout of new modules and enhancements, including integrations (e.g., Argus, SAP).
• Act as Level 3 escalation, ensuring timely resolution of incidents within SLAs.
• Ensure full adherence to ITIL processes and perform RCA for recurring issues.
• Maintain validated system state in line with GxP and CSV expectations.

Enterprise Administrative & Financial Oversight

• Support Veeva licensing lifecycle activities, including renewals and usage tracking.
• Provide license usage reports to support affiliate recharge processes.
• Maintain accurate and real-time reporting of license consumption.

Mentorship & Team Development

• Provide mentorship and training to junior staff and new team members.
• Conduct configuration reviews and enforce best practices.
• Promote knowledge-sharing and continuous improvement.
• Manage third-party service providers to ensure compliance with Aspen standards.

Cross-Functional Pharmacovigilance (PV) Support – Argus

• Provide support during Argus audits, upgrades, and high-demand cycles.
• Collaborate with the Argus team on interface and data flow management.
• Conduct system health checks and support PV troubleshooting.

Governance & Compliance

• Ensure Veeva Vault compliance with GxP, CSV, 21 CFR Part 11, and internal procedures.
• Participate in audits, CAPAs, and validation exercises.
• Ensure all related SOPs are up to date and that standardised ITIL processes are followed.

Stakeholder Engagement & Business Partnering

• Build and maintain strong relationships with Regulatory, Quality, Clinical, and PV business stakeholders. 
• Act as a trusted advisor on Veeva Vault capabilities, system implications, and best practices. 
• Facilitate alignment between business needs and platform functionality

Service Delivery & Operational Excellence

• Ensure operational excellence of supported platforms through proactive monitoring, service availability management, and performance oversight.
• Drive continuous improvement initiatives to enhance service quality, reduce incidents, and optimise support efficiency.
• Maintain high customer satisfaction by ensuring timely, high-quality resolution of issues.

Vendor / Service Provider Management

• Manage external vendors and service providers to ensure delivery within Aspen standards, SLAs, and quality parameters.
• Review vendor deliverables, monitor performance, and escalate issues when needed.
• Participate in commercial / renewal discussions relating to platform support services.

Documentation, SOP Management & Knowledge Management

• Ensure system documentation, SOPs, work instructions, and support artefacts are accurate, current, and audit-ready.
• Maintain configuration documentation, system logs, validation artefacts, and support playbooks.
• Drive knowledge-sharing initiatives within the support team and across functional teams.

Risk Management & Issue Prevention

• Identify platform risks, recurring incidents, and potential compliance gaps; implement mitigation activities.
• Conduct trend analysis on incidents and problems to prevent recurrence.
• Flag emerging risks related to system performance, user behaviour, or infrastructure dependencies.

Change Enablement & Release Readiness

• Coordinate and execute change management activities for Veeva Vault and related integrations.
• Ensure readiness for quarterly Veeva releases, including impact assessments, testing plans, and deployment communication.
• Support business change impacts through communication, training, and adoption support.

Reporting & Performance Metrics

• Produce regular reports on system performance, incidents, request volumes, SLA compliance, and platform usage.
• Provide management with insights and recommendations based on operational data and support trends.
• Track and report license usage and cost allocation metrics.

Requirements

• Bachelor’s degree in computer science, Information Technology, Life Sciences, or related field.
• Veeva Vault Administrator Certification (required).
• GxP / CSV (Computer System Validation) training or certification (preferred).
• ITIL Certification or formal ITIL training.
• Agile / Scrum experience (advantageous).
• 6–10 years’ experience in technical support, system administration, or application support with Veeva Vault.
• Experience supporting multiple Vault modules (e.g., QualityDocs, PromoMats, RIM, QMS, eTMF).
• Experience working in GxP-controlled environments with validation obligations.
• Exposure to integrations between Veeva Vault and systems such as Argus or SAP
• Strong knowledge of Veeva Vault data models, workflows, lifecycles, security, and configuration.
• Experience with release management processes and regression testing.
• Familiarity with 21 CFR Part 11, data integrity, and system validation requirements.
• Experience supporting system interfaces, troubleshooting, and issue resolution.
• Knowledge of Argus Safety processes and ability to support PV system activities.
• Veeva Vault configuration and administration.
• Incident, problem, change, and request management within ITIL frameworks.
• Structured problem-solving and RCA methodologies.
• Audit readiness, documentation discipline,
• Ability to collaborate with cross-functional teams, including Regulatory, Quality, Clinical, and PV.