Manager: Regulatory & Quality Applications

Aspen Pharma Group; Johannesburg; On-site; ZAR 900 000 - 1 200 000; Full time

Job summary

A leading pharmaceutical company is seeking a Manager: Regulatory & Quality Applications to lead a team in Johannesburg. The role involves oversight of Veeva and Oracle Argus systems, ensuring regulatory compliance, and managing team operations. Ideal candidates will have extensive IT experience in life sciences and strong leadership skills. This position offers an office-based environment and requires a proactive approach to problem-solving.

Qualifications

• 7-10+ years of IT experience in the life sciences or pharmaceutical industry.
• 3-5+ years in a leadership or team management role within IT application support.
• Strong understanding of GxP, FDA 21 CFR Part 11, and system validation (CSV).

Responsibilities

• Lead and mentor a team supporting Veeva and Argus PV systems.
• Ensure systems are maintained in a validated state per GxP and FDA compliance.
• Generate regular reports on system performance and SLA compliance.

Skills

Veeva (RIMS, QDocs, QMS)

Oracle Argus Safety (PV)

ITIL processes

regulatory compliance

budgeting

financial tracking

Education

Bachelor's degree in computer science, IT, Life Sciences

Tools

ServiceNow

JIRA

Job description

This role is office-based (on-site)

Company Description

Aspen TESS is Aspen's technology enabled shared services business, established to be a partner in unlocking business value through digital innovation and process efficiency. Aspen TESS will eliminate repetitive effort and use technology to optimize standardized processes, by delivering cost-effective services and innovative solutions to Aspen business units globally.

OBJECTIVE

We are seeking a highly motivated Manager: Regulatory & Quality Applications with a strong background in supporting life sciences/pharmaceutical systems, particularly Veeva (RIMS, QDocs, QMS, Safety) and Oracle Argus Safety (PV). The ideal candidate will lead a team responsible for the day-to-day support, incident and change management, SLA monitoring, and compliance oversight of validated GxP systems. This role requires a leader capable of both tactical oversight and hands-on operational support, with experience in budgeting, business unit recharging, and ensuring regulatory compliance.

Key Responsibilities

Team Leadership & Operational Oversight

• Lead and mentor a team supporting Veeva (RIMS, QDocs, QMS), Argus PV, and other validated systems.
• Ensure team adherence to ITIL processes for Incident, Request, Problem, and Change Management.
• Manage team workload and capacity, ensuring timely resolution of support tickets within defined SLAs.
• Provide technical and operational guidance to the team and act as the point of escalation.

System & Compliance Management

• Ensure all systems are maintained in a validated state per GxP and FDA compliance standards.
• Oversee periodic system audits, CAPAs, and ensure proper documentation for compliance and inspections.
• Coordinate with Quality and Compliance teams on periodic reviews and validation lifecycle activities.

Performance Monitoring & Reporting

• Generate regular reports on system performance, SLA compliance, incident trends, and support metrics.
• Track KPIs to identify areas of improvement and implement corrective measures.
• Communicate metrics and system health status to IT leadership and business stakeholders.

Project Involvement

• Provide oversight for system upgrades, enhancements, and implementation projects.
• Support project planning, resource allocation, and milestone tracking.
• Collaborate with vendors, internal teams, and project managers to deliver successful outcomes.

Financial Management

• Assist with IT budgeting, including annual budget planning for supported systems and services.
• Implement and manage cost recharging models for business units based on usage/support levels.
• Track operational spend and ensure alignment with forecasts and budget constraints.

Qualifications & Skills

Education

Bachelor’s degree in computer science, Information Technology, Life Sciences, or a related field preferred.

Experience

• 7-10+ years of IT experience in the life sciences or pharmaceutical industry.
• 3-5+ years in a leadership or team management role within IT application support.
• Experience with one or more of the following products:
• Veeva Vault Suite: RIMS, QDocs, QMS
• Oracle Argus Safety (PV)
• Knowledge of related pharma systems like TrackWise, MedDRA, etc., is a plus.
• Strong understanding of GxP, FDA 21 CFR Part 11, and system validation (CSV).
• Familiarity with ITIL framework and tools such as ServiceNow, JIRA, or equivalent.
• Proven experience with budgeting, financial tracking, and recharging models.
• Demonstrated ability to produce performance dashboards, service metrics, and SLA reports.
• Excellent communication, stakeholder management, and escalation handling skills.
• Ability to work in a fast-paced, regulated environment with multiple priorities.

Soft Skills

• Proactive problem-solver and strategic thinker.
• Strong leadership and interpersonal skills.
• High attention to detail, especially concerning regulatory compliance.
• Excellent verbal and written communication abilities.

Preferred Certifications

• ITIL Foundation Certification (Intermediate or Expert a plus).
• Veeva Vault or Argus Certification (preferred but not mandatory).
• Project Management experience or certification (PMP or Prince2 is a plus).