IT Manager

Title: IT Manager
Location: Brooksville, FL
Industry: Pharmaceutical
Salary: 110k and up depending on experience
Employment Type: Direct Hire

Client Overview:
Our client is a US-based sterile injectable manufacturer of parenteral drugs with a world-class facility focused on ready-to-use pre-filled syringes and vials. The company's product line includes small molecule 505(b)(2) NDA and 505(j) ANDA syringe and vial products, and it serves as an outsourced contract manufacturing partner for strategic pharmaceutical companies.

Position Overview:
As an IT Manager at our pharmaceutical manufacturing company, you will be responsible for overseeing and managing all aspects of information technology infrastructure and systems. Your role will involve developing and implementing IT strategies, ensuring network security, managing software applications, and providing technical support to our employees. You will collaborate with cross-functional teams to align IT initiatives with business goals and regulatory requirements within the pharmaceutical industry adhering to safety and GMP regulations.

Responsibilities:

• Serve as the IT Operational Subject Matter Expert (SME) for Qualification/Validation for GxP equipment and computerized systems utilizing the Good Automated Manufacturing Practices (GAMP) life cycle methodology, FDA guides and current industry standards best practices to meet the requirements of internal policies, U.S. and International regulatory agencies.
• Oversee the installation, configuration, and maintenance of computer hardware, software, networks, and servers.
• Monitor and manage system performance, availability, and capacity.
• Ensure data backups, disaster recovery, and business continuity plans are in place and tested regularly.
• Oversee the installation, configuration, and maintenance of computer hardware, software, networks, and servers.
• Monitor and manage system performance, availability, and capacity.
• Ensure data backups, disaster recovery, and business continuity plans are in place and tested regularly.
• Conduct regular risk assessments and implement measures to protect sensitive data and systems.
• Provide technical support and troubleshooting assistance to end-users.
• Collaborate with external vendors, contractors, and service providers to ensure smooth operation of IT systems.
• Evaluate vendor proposals, negotiate contracts, and manage vendor relationships.
• Monitor vendor performance and enforce contractual obligations.
• Develop and implement a comprehensive IT strategy aligned with business objectives, including information security policies, procedures, and best practices.
• Identify and recommend technology solutions to enhance operational efficiency and competitiveness.
• Coordinate with internal stakeholders to develop corrective and preventative actions to address identified non-conformities
• Liaise with regulatory agencies to ensure compliance with relevant laws and regulations, and prepare for and participate in regulatory inspections.
• Ensure data integrity and security of electronic records, and monitor system usage to detect and prevent data manipulation or loss.
• Keep up-to-date with changes to regulatory requirements and industry best practices, and proactively identify areas for improvement within the quality management system.

• Experience with electronic document management systems and other IT systems used in a pharmaceutical manufacturing environment
• Strong analytical skills and attention to detail, with the ability to identify and address potential compliance issues
• Excellent communication and interpersonal skills, with the ability to effectively liaise with internal and external stakeholders
• Ability to work independently and as part of a team, with a strong sense of accountability and ownership of tasks and responsibilities
• Certification in IT, quality management or regulatory compliance (e.g. RAC, CQA) would be an advantage

• Bachelor's degree in Information Technology, Computer Science, or a related field (Master's degree preferred).
• Proven experience as an IT Manager or similar role in the pharmaceutical or healthcare industry, minimum 4 years direct experience.
• Solid understanding of pharmaceutical industry regulations, such as GMP and FDA guidelines.

• Employee may be required to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function.
• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents (including potent compounds).

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

EOE/ADA

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