Job Description

Job Description

Job Description

Job Purpose:
Lead the implementation, enhancement, and deployment of Quality, Regulatory, and Laboratory Systems (QRLS) across multiple sites, ensuring alignment with business objectives and regulatory compliance. This role focuses on managing high-impact quality system projects, coordinating cross-functional teams, and maintaining strong stakeholder relationships to ensure successful project delivery.

Key Responsibilities:

• Manage the end-to-end project lifecycle for QMS, LIMS, and RIM systems, including planning, execution, monitoring, and completion, while adhering to established project management best practices.
• Develop and maintain detailed project plans, including resource allocation, timelines, budgets, and risk management strategies for system implementations.
• Serve as the primary point of contact for all project stakeholders, including IT teams, Quality departments, vendors, regulatory bodies, and business units, ensuring alignment and smooth execution.
• Track and report on project progress, risks, and issues through structured governance processes, ensuring transparency and timely decision-making.
• Oversee scope management, change control, and dependencies while ensuring the project remains focused on business goals and regulatory compliance.
• Lead project steering committee meetings, provide regular status updates, and ensure ongoing stakeholder engagement throughout the project lifecycle.
• Maintain project documentation, including project charters, requirements documents, status reports, and closure reports, in accordance with GxP guidelines.
• Manage vendor relationships, including contract negotiations, SLA monitoring, and performance evaluation for QRLS-related services and solutions.
• Champion continuous improvement initiatives to enhance project delivery and quality system implementation practices.

Communication & Working Relationships:

• Internal: Function Heads, Business SMEs, End Users, IT SMEs
• External: IT Vendors

Qualifications:

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

Experience:

• Minimum 7 years of project management experience, with at least 4 years in managing quality system implementations within the pharmaceutical industry.
• Proven track record of delivering large-scale IT projects within a GxP-regulated environment.
• Experience with the implementation of quality systems such as QMS, LIMS, or Document Management Systems.
• Strong background in pharmaceutical industry regulations and compliance standards.
• Required: Experience with quality system validation processes and associated 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 project management skills, including risk management, stakeholder engagement, and change management.
• In-depth knowledge of pharmaceutical industry regulations (GxP, FDA, EMA) and their impact on IT systems.
• Proven leadership capabilities with experience in managing cross-functional teams.
• Advanced financial management skills, including budgeting, forecasting, and cost control.
• Strong negotiation and conflict resolution skills.
• Excellent communication skills with the ability to translate complex information to diverse stakeholder groups.
• Proficient in project management tools (e.g., MS Project) and Microsoft Office Suite.
• Strong analytical and problem-solving abilities.
• Solid understanding of computer system validation principles and practices.
• Knowledge of quality management systems and processes within the pharmaceutical industry.
• Basic technical troubleshooting and system administration skills.

The ambition of RennerBrown is to provide the resources and opportunities necessary to attract, train, and retain our associates to ensure they fulfill our quality commitment to our clients. We provide IT solutions in NYC, NJ, Pa and beyond, and valuing quality above quantity will continue to make RennerBrown the premium choice for resources and opportunities: “our people deliver quality to our clients.”

Company Description

The ambition of RennerBrown is to provide the resources and opportunities necessary to attract, train, and retain our associates to ensure they fulfill our quality commitment to our clients. We provide IT solutions in NYC, NJ, Pa and beyond, and valuing quality above quantity will continue to make RennerBrown the premium choice for resources and opportunities: “our people deliver quality to our clients.”

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