Job Description
The Project Manager will manage projects by analyzing information, developing and tracking project plans, providing expertise to resolve project difficulties and directing resources.
Qualifications
ESSENTIALS OF THE JOB:
- Project Leadership: Lead the planning, execution, monitoring, and closing of IT projects within scope, on time, and within budget.
- Stakeholder Management: Collaborate with cross-functional teams, including Quality Assurance, Regulatory, and Manufacturing, to align IT projects with business objectives.
- Risk Management: Identify project risks and develop mitigation strategies to ensure smooth project execution, especially concerning data integrity and regulatory compliance.
- Documentation: Maintain comprehensive project documentation, including project plans, status reports, and post-implementation reviews, in alignment with documentation standards.
- Vendor Coordination: Manage external vendors and service providers, ensuring that project deliverables meet contractual obligations and quality standards.
- System Implementation: Oversee the implementation of new IT systems and upgrades, ensuring that they meet the needs of the business and comply with industry standards, particularly in data integrity and validation.
- Compliance: Ensure all IT projects comply with relevant FDA regulations, including 21 CFR Part 11, and internal Standard Operating Procedures (SOPs).
- Resource Management: Allocate resources effectively, coordinating with department heads to ensure adequate staffing for project tasks.
- Continuous Improvement: Drive continuous improvement initiatives within the IT department, applying best practices in project management and agile methodologies.
- Training & Support: Provide training to end-users and IT staff on new systems and processes to ensure successful adoption and usage.
Education Requirements
Bachelor’s degree in science, engineering or business is required.
Experience Requirements
A minimum of five years of experience in a biopharmaceutical environment including: laboratory, manufacturing, engineering, quality assurance etc.
