IT Administrator - Eckert & Ziegler Radiopharma Inc

Job Title: GMP IT Consultant

Job Description:

We are seeking a highly skilled and experienced GMP IT Consultant to join our team and provide expert guidance on IT infrastructure and compliance within the pharmaceutical industry. The ideal candidate will have a deep understanding of GMP regulations, particularly in the context of radiopharmaceutical products, and can effectively bridge the gap between IT and business operations.

This person will work in the context of a remotely-managed IT infrastructure in the foreseeable future.

Key Responsibilities:

• GMP Compliance Assessment: Conduct comprehensive audits and assessments to ensure IT systems and processes align with GMP regulations, including FDA 21 CFR Part 11.
• IT Infrastructure Design and Implementation: Develop and implement IT infrastructure solutions that meet the specific needs of GMP-regulated environments, considering factors such as data integrity, security, and regulatory compliance.
• Risk Assessment and Mitigation: Identify potential risks to IT systems and processes and implement effective mitigation strategies to protect data and ensure compliance.
• Regulatory Guidance: Provide expert advice on regulatory requirements, including FDA guidance, and assist in developing compliance strategies.
• IT Project Management: Oversee IT projects related to GMP compliance, ensuring timely delivery and adherence to quality standards.
• Vendor Management: Evaluate and select IT vendors and service providers that can meet the company's GMP compliance needs.
• Documentation and Training: Develop and maintain comprehensive documentation related to GMP compliance, including standard operating procedures (SOPs) and training materials.
• Continuous Improvement: Identify opportunities for process improvement and implement changes to enhance efficiency and compliance.

Qualifications:

• Bachelor's degree in Computer Science, Information Systems, or a related field.
• Minimum of 5 years of experience in IT consulting, with a focus on GMP-regulated industries.
• Strong understanding of GMP regulations, particularly for radiopharmaceutical products.
• Experience with IT infrastructure design, implementation, and maintenance.
• Knowledge of IT security best practices and risk management.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.

Expectations:

Year 1:

• Conduct a comprehensive assessment of the company's IT infrastructure and compliance posture.
• Develop a roadmap for achieving and maintaining GMP compliance.
• Provide guidance on IT projects and initiatives related to compliance.

Year 2:

• Implement recommended IT infrastructure improvements to enhance compliance and efficiency.
• Develop and deliver training programs on GMP compliance for IT and business staff.
• Monitor and report on compliance metrics.

Year 3:

• Serve as a subject matter expert on GMP compliance within the organization.
• Assist in the development of long-term IT strategy aligned with compliance goals.
• Stay up-to-date on industry trends and regulatory changes.