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Information Technology Project Manager

4 months ago

WinstonSalem, United States Scaleneworks Full time

Job Description:

Its a FTE role based in Winston Salem.

Description:

The Senior Manager, GMP Site Systems is responsible for the implementation and support of technology and informatics systems/tools and programs to support the development, implementation, operation, and continuous improvement of GMP Technical Operations including but not limited to manufacturing, quality assurance, quality control, supply chain, patient experience, facilities/engineering, and technical development.

The Senior Manager, GMP Site Systems will serve as overall business partner for day-to-day activities and support. The senior manager will support all facets of site support including identification of business needs, crafting solution, implementation of site digital capabilities, addressing issues, and provide status to site teams. The senior manager, GMP Site Systems, will report to Senior Director, GMP Systems. The senior manager will partner with other internal IT teams such as IT assurance and compliance, program management, and IT operations to meet business needs.

The systems in scope may include ERP, MES, Electronic Batch Record, Laboratory Systems, Quality Management, Document Management, Facilities management, GMP Labeling, Barcoding, Shop-Floor Systems, and data management and analytics. The Senior Management will collaborate with stakeholders to help drive digital transformation to support goals for clinical and commercial manufacturing. The position will provide oversight of contractors and external partners to provide the oversight.

The position requires a broad understanding of GMP regulatory frameworks and obligations. This is a highly integrated role touching many functions across the business and requires the ability to translate business problems into technology solutions, project plan, and project manage, to drive alignment and performance across the business. The position requires enthusiasm, passion, attention to detail and a desire to create new medicines for patients.

Responsibilities:

The position will perform the role of system administrator for site GMP systems. The responsibility will include support user account creation and system life cycle management.

Resolve issues related to GMP Systems, identifying root causes of problems, and providing technical support to users or other teams within the organization.

Ensuring that IT processes and procedures are well documented and followed for compliance.

Minimum Requirements:

Education/Training Bachelors degree in computer science or related discipline, or equivalent experience.

Experience 5-10 years of implementing and supporting IT within manufacturing/supply chain in biotechnology or life sciences companies.

Strong Working Experience in developing and driving Computer System Validation program initiatives including GxP systems and ensuring CFR part 11 compliance.

Experience leveraging digital systems to drive business workflows and processes in quality-manufacturing production environments.

Experience with shop floor automation, ERP, MES, Quality, Laboratory, Warehouse, Engineering/Facilities, Supply Chain, and Chain of Custody/Chain of Identity,

Experience with implementing and automation of warehouse.

Experience with Manufacturing Execution System/ Electronic Batch Record

Experience with commissioning and validation of shop-floor equipment and devices

Experience to articulate strategy and vision for Industry 4.0, and Internet of Things (IOT)

Previous experience working in GMP Environment is required.

Skills/Abilities:

Strong project and portfolio management skills. Ability to oversee multiple projects, activities and tasks simultaneously.

Ability to solve problems using structured methodology

Skilled in using continuous improvement frameworks (Kaizen, LEAN, Six Sigma)

Skilled with business process improvements and design

Strong technology background with manufacturing and supply chain across BioPharma/Cell Therapy Industry

Experience with Data and analytics platforms including ability to use AI/ML