Manager: Regulatory

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).