Director, Informational Technology

summary

Provide strategic and operational direction of the Company's IT initiatives in support of its business goals. Direct the planning and implementation of systems and technology in support of business operations to improve cost effectiveness, service quality, and productivity. Drive compliance within the IT department, coordinating efforts with system owners to ensure computer systems are delivered and maintained in a qualified state. Create and reinforce a service and compliance culture.

essential Duties and Responsibilities

• Provide comprehensive formal and informal leadership to promote a positive work environment and to communicate overall business expectations to all working groups.
• Define and champion support strategies and plans to deploy infrastructure, enterprise architecture and technology functions that are closely integrated with business applications and utilities ensuring they meet availability, scalability, and business continuity goals.
• Collaborate with senior leaders and executive management to ensure technology, policies, standards, and tools effectively support the achievement of strategic business goals and IT portfolio criteria.
• Direct IT department's operational and strategic planning, including business requirements, budget, project planning and organizing, and negotiating the allocation of resources.
• Provide technical guidance and oversight for major enterprise infrastructure projects that vary in scope and complexity.
• Lead the identification and selection of new technologies; develop and communicate roadmaps for these technologies as well as define and implement infrastructure solutions that directly address business requirements.
• Work with executive management to prepare and secure approvals for CapEx and OpEx IT budgets to support company objectives, projects, applications, infrastructure and support. Assess and communicate risks associated with technology-related investments and purchases.
• Develop and maintain computer operations production SOPs and documentation. Establish and oversee data integrity policies especially for Lab Computer software (stand-alone and enterprise systems) to comply with regulatory guidance and requirements (e.g., 21 CFR Part 11).
• Maintain regulatory compliance and monitor regulatory guidelines as they pertain to information technology, to determine impact to business processes, network and security functions.
• Oversee process to monitor information security controls within the IT department and the business functions for exceptions to established policy standards, security violations, and significant system changes, as well as risk mitigation initiatives.
• Oversee continuous delivery of IT services through oversight of service level agreements with end users and monitoring of IT systems performance.
• Evaluate, negotiate, develop, and manage vendor service provider relationships to deliver the highest value and quality IT services.
• Develop and monitor the organization's Disaster Recovery strategies/methodologies; serve as the key contact with Company's management; coordinate IT activities in the event of a disaster.
• Partner with senior leaders to forecast, secure and allocate personnel to approved and budgeted projects utilizing methods which strike the best balance between the priorities of the business and IT, project requirements and staff development.
• Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training.
• Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
• Serve as a Quality Council member and as an IT subject matter expert for Change Controls, CAPAs, and Deviations.
• Participate and support the organization during internal and external audits such as US FDA and other third party regulatory inspections.
• Keep current with trends and issues in the IT and pharmaceutical industry, including current technologies and policies. Advise, counsel, and educate management on their strategic business impact.
• Exhibit behaviors consistent with Company values at all times.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.
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KNOWLEDGE/SKILLS/ABILITIES

• Broad, yet deep knowledge across the full range of IT service domains including data center operations, telecommunications, cloud computing technologies, networking, server technologies, virtualization, storage area network, disaster recovery, backups & restore, service delivery and support process improvement.
• In-depth knowledge of regulations such as GAMP5 and 21 CFR Part 11 governing IT activities in highly regulated environments.
• Proven ability to manage ERP systems. Solid understanding of the ERP functional and technical landscapes of these systems.
• Proven skills to diagnose and resolve complex system problems.
• Proven leadership and interpersonal skills to effectively lead, influence, collaborate, and work with diverse teams and individuals at all levels throughout the organization, with the ability to coach and mentor personnel to consistently high standards.
• Highly organized with strong project management skills to effectively manage multiple priorities, projects and requirements in a fast paced, dynamic environment.
• Excellent communication skills to effectively communicate in a clear, concise manner whether in oral, written or presentation form.
• Ability to understand and interpret the needs of the end user and apply application and systems knowledge to identify appropriate solutions.

EDUCATION/EXPERIENCE

• Bachelor's degree in Computer Science required or the equivalent combination of education and pertinent, progressive experience with increasing levels of responsibility.
• Ten years' IT management experience.
• Experience with ERP systems such as ( Ross CDC ERP, SAP, JD Edwards ), Kronos, MS Project, UNIX, Business Objects, Crystal Reports
• Professional certifications in Project Management, Service Management and Security such as PMP, ITIL, and CISM preferred.
• Extensive experience managing medium and large infrastructure projects within pharmaceutical or other highly regulated industry.
• Experience negotiating contracts and agreements with IT vendors.
• Proven experience in a multi-computer platform environment required; cGMP environment preferred.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is:

1. Frequently required to sit and/or stand, walk, talk and hear.
2. Constantly required to use hands and fingers to operate office machines and equipment.
3. Frequently required to reach with hands and arms.
4. Occasionally required to stoop, kneel and crouch.
5. Required to have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
6. Required to exert a negligible amount of force continuously and/or up to five pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job.

1. Normal office conditions.

Personal Protective Equipment is required to be worn if assigned to perform work or tasks in specific production areas.

• Eye protection (safety glasses).
• Foot Protection (steel or composite toe safety shoes).

Current Openings for Director, Informational Technology Jobs at Nesher Pharmaceuticals (USA) LLC