K2 Partnering Solutions is seeking a Site IT Operations Lead (Manufacturing) to work with a Medical Device client for 10+ months. This is an onsite position based in Houston, TX.
Temporary IT Lead Site IT Operations
As the temporary IT Lead you will assist the Site IT Head with all IT operations, providing both strategic and tactical operational leadership for information technology systems & services. This includes oversight of IT Operations, End User Support & Service Delivery (Help Desk Operations), and Local Application Support & Delivery. The role will also serve as a Delegate to the Site IT Head and will be a business relationship partner to Site Manufacturing, Engineering, Materials & Supply Chain, Quality, HR and Finance departments ensuring alignment, governance and prioritization of IT initiatives.
As delegated by the Site IT Head, will be responsible for ensuring the delivery of IT services to support day-to-day manufacturing operations.
Lead, direct and motivate the IT Department, ensuring that the structure, skills and competencies required are applied correctly to the appropriate business needs.
Prioritize, oversee, and manage IT service requests and portfolio of IT projects in support of strategic business goals. Ensure delivery of services within determined time and budgetary constraints
Serve as a senior point of contact for IT Department on operational and strategic issues.
Communicate to site leadership team (SLT), monthly performance through project reporting and key metrics to create awareness and highlight challenges and risks.
Conduct business relationship management meetings with Site leadership to keep the business partners informed of key IT activities.
Interpret business requirements, identify & report back any demand requests for IT services.
Interpret business requirements, identify & report back any IT improvement opportunities.
Provide operational support and drive improvements for IT services.
Ensure plans are in place for business continuity for all IT systems.
Develops strategic plans and budgets that meet the growth, scale and changing needs of the business
Working with Quality Assurance Validation, use risk-based approaches to assess compliance impacts & build computer systems validation processes into system implementation & change control activities where appropriate
Support and develop standard operating procedures for computer systems operating in a regulated environment ensuring 21 CFR Part 11 compliance.
Position Requirements & Experience:
5+ years in IT Leadership roles
8-12 years business/industry work experience including extensive knowledge and expertise in supporting Manufacturing operations.
Bachelor's or Master's degree in Computer Science, Information Systems, or other related field
Deep expertise in project/program management, systems lifecycle management and enterprise application planning.
Previous experience in the biotechnology / pharmaceutical industries and GMP Quality Systems.
Experience with key business solutions such as Kronos, SharePoint, MES, ERP, QMS, LIMS, and PLM.
Experience with negotiating and managing vendor relationships and agreements, specifically for manufacturing solutions.
Strong project and portfolio management skills; Ability to oversee multiple projects, activities and tasks simultaneously
Effective risk analysis, prioritization and stakeholder facilitation to reach timely decisions.
Excellent management skills with demonstrated organizational, administrative, interpersonal, communication and supervisory skills with the demonstrated ability to work with a wide variety of people including both internal and external resources.
Ability to influence across levels and functions, develop strategic plans and communicate strategy in a way that is easy to understand.