Title:  Project Manager, IT Applications - QRLS

2. JOB PURPOSE

Lead and manage the implementation, enhancement, and rollout of Quality, Regulatory, and Laboratory Systems (QRLS) across multiple sites while ensuring alignment with business objectives and regulatory compliance. The role focuses primarily on delivering high-impact quality system projects, coordinating cross-functional teams, and maintaining strong stakeholder relationships to drive successful project outcomes. Additionally, provide operational support and system management for existing QRLS applications to ensure continuous system effectiveness in the pharmaceutical industry.

3. KEY ACCOUNTABILITIES

ACCOUNTABILITIES:

• Lead end-to-end project management of QMS, LIMS, and RIM implementations, upgrades, and enhancements, including planning, execution, monitoring, and closure phases while adhering to established project management methodologies.
• Develop and maintain comprehensive project plans, including resource allocation, timeline management, budget control, and risk mitigation strategies for quality system implementations.
• Coordinate and facilitate communication between various stakeholders including IT teams, Quality departments, vendors, regulatory bodies, and business units to ensure project alignment and successful delivery.
• Monitor and report project progress, risks, and issues to key stakeholders through structured governance frameworks, ensuring transparency and timely decision-making.
• Manage project scope, changes, and dependencies while maintaining focus on business objectives and regulatory compliance requirements.
• Lead project steering committee meetings, status updates, and stakeholder communications to maintain project momentum and stakeholder engagement.
• Develop and maintain project documentation including project charters, requirements documents, status reports, and closure reports in compliance with GxP regulations.
• Oversee vendor management activities including contract negotiations, SLA monitoring, and performance management for QRLS-related services and solutions.
• Drive continuous improvement initiatives in project delivery methodologies and quality system implementation approaches.
• Provide operational support for existing QRLS applications, including troubleshooting issues and coordinating with technical teams for resolution
• Assist in system maintenance activities and periodic reviews to ensure optimal performance
• Support system security administration and access management according to SOPs
• Contribute to system enhancement discussions and provide input for continuous improvement initiatives
• Participate in system validation activities and documentation updates as needed

4. COMMUNICATIONS & WORKING RELATIONSHIPS

Internal

• Function Heads
• Business SMEs
• End users
• IT SMEs

External:

• IT Vendors

5. QUALIFICATIONS, EXPERIENCE, & SKILLS

QUALIFICATIONS

• Bachelor's degree in Computer Science, Information Technology, Engineering, or related field
• Additional certifications in quality management or pharmaceutical regulations preferred

EXPERIENCE

• Minimum of 7 years of project management experience, with at least 4 years specifically managing quality system implementations in the pharmaceutical industry
• Proven track record of successfully delivering large-scale IT projects in a GxP-regulated environment
• Experience in managing quality system implementations such as QMS, LIMS, or Document Management Systems
• Strong background in pharmaceutical industry regulations and compliance requirements
• Required: Experience with quality system validation processes and documentation
• Required: Working knowledge of system support and maintenance in a GxP environment
• Preferred: Experience with Veeva, Labware LIMS, or similar quality systems
• Preferred: PMP certification or equivalent project management qualification

SKILLS

• Expert-level project management skills including risk management, stakeholder management, and change management
• Strong understanding of pharmaceutical industry regulations (GxP, FDA, EMA) and their impact on IT systems
• Excellent leadership abilities with demonstrated experience in managing cross-functional teams
• Advanced financial management skills including budgeting, forecasting, and cost control
• Strong negotiation and conflict resolution skills
• Exceptional communication skills with ability to present complex information to various stakeholder levels
• Proficient in project management tools (MS Project, Jira, etc.) and Microsoft Office Suite
• Strong analytical and problem-solving capabilities
• Understanding of computer system validation principles and requirements
• Knowledge of quality management processes and systems in the pharmaceutical industry
• Basic technical troubleshooting and system administration capabilities