Position: Position: Digital Transformation Project Manager

Location: North Carolina
Employment Type: Full-Time
Schedule: Standard business hours, Monday–Friday
Salary Range: $150,000 – $165,000 Annually

Role Summary

The Digital Transformation Project Manager will oversee the planning, coordination, and execution of digital initiatives to optimize processes and ensure compliance with regulatory standards. This role requires a strong background in IT systems, operational excellence, and pharmaceutical manufacturing practices, with a focus on integrating advanced digital tools across production and quality functions.

Key Responsibilities

• Lead the design, planning, and execution of digitalization projects that align with business objectives and compliance requirements.
• Prepare and manage detailed project plans, including schedules, milestones, budgets, and resource allocation.
• Oversee progress, identify risks, and implement mitigation strategies to ensure timely delivery of project goals.
• Collaborate with cross-functional teams—IT, operations, quality, and regulatory—to ensure seamless project integration.
• Provide expertise in areas such as electronic batch records, automation solutions, and other advanced digital platforms.
• Support validation and compliance processes to meet FDA, EMA, and other regulatory standards.
• Conduct system testing and ensure successful implementation of digital solutions.
• Deliver training and provide ongoing support to ensure smooth adoption of new processes and technologies.
• Maintain effective communication with stakeholders, providing updates on progress, outcomes, and key deliverables.
• Assist with incident management and first-level support for implemented systems.
• Ensure adherence to internal standards related to health, safety, environment, energy, and quality management.

Qualifications

• Bachelor’s or Master’s degree in computer science, engineering, or related field.
• 5+ years of relevant experience, with at least 3 years in IT implementation projects and production environments (pharmaceutical industry preferred).
• Proven track record of managing digital transformation initiatives and implementing systems such as MES, LIMS, or ERP.
• Strong knowledge of GMP, Computer System Validation (CSV), and GAMP practices.
• Excellent communication, presentation, and problem-solving skills.
• Ability to work independently and collaboratively in a dynamic, fast-paced environment.
• Proficiency in English; additional language skills (e.g., German) are advantageous.