Director, Laboratory Architecture and Software

Our client is a premier CDMO with over 65 years of sterile injectable experience.

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As the Director of Laboratory Software and Systems, you will play a critical role in leading and implementing technologies to enhance our lab’s productivity, quality, and throughput through the utilization of software and the implementation of digital technologies. The role involves strong communication and collaboration with Quality, Regulatory, R&D, and production laboratory groups in a fast-paced biopharmaceutical environment to gather business and functional requirements and deliver applications and technology solutions that improve and support business processes and our laboratory’s growth. You will be accountable for architecting, testing and documenting system changes as required by GMP and ISO standards. Your ability to translate the requirements of our internal customers into robust solutions will be essential in this role.

Key Responsibilities

• Responsible for the design and support of the LIMS supporting laboratory operations, including systems analysis, process & procedure creation, customized reports, modifications, user account management, barcode / printer management, and upkeep of systems administration tasks.
• Lead and coordinate LIMS Super Users, LIMS Admins, offshore support, and Help Desk for all laboratory applications.
• Drive and support data integrity processes for all laboratory-related software applications.
• Collaborate with the QA department to support the GMP / ISO accreditation processes through validation activities; develop and / or execute test scripts as required.
• Lead and oversee the development of Standard Operating Procedures, User Guides, and other relevant documentation for the LIMS and related applications.
• Collaborate with management and other IT staff on business requirements to ensure adequate infrastructure support to lab systems, including all upgrades to hardware and software.
• Participate in internal and external audit reviews of the system and other lab IT-related topics.
• Lead laboratory systems upgrades and maintenance on a frequent and recurring basis while complying with GxP requirements.
• Provide vendor management support by working with vendors on implementation, future upgrades, modifications, and other laboratory business needs.
• Provide high-level project management for any LIMS projects using best practices for change control and security of systems.
• Manage effective data exchange between LIMS and all lab instruments and other associated systems.
• Direct and control the strategic software / informatics roadmap to balance regional, business unit, and corporate goals.
• Provide leadership in problem-solving, which requires consideration of the IT strategic plan and short-term goals, the means by which to solve the problem, and development of associated action plans.
• Create and maintain technical documentation and architecture diagrams as required.
• Assist in assessing the strategic direction of information technology and in developing strategic plans for the use of new technology and applications.

Key Requirements

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