Our pharma client is seeking a Technical Systems Manager for Quality Systems Operations for a long term contract opportunity. . This is a 100% remote role operating on East Coast business hours. The successful candidate will have a strong background in pharma and will be Veeva certified.
This role will provide technical administration and general system support for projects. The systems that will be supported by the TSM include the following:

1. Vault QMS
2. Vault Quality Docs
3. Additional systems to be implemented

Essential Functions:

• Responsible for ensuring day-to-day operational support to meet business expectations and compliance requirements.
• Vital to the implementation of new systems and upgrades of existing systems. Provides technical leadership and subject matter expertise on projects to effectively manage business user expectations and timelines.
• Ability to coordinate with Managed Service technical support personnel where applicable.
• Works collaboratively with Corporate IT in the management of enterprise systems, the development and adherence of standards and governance, enterprise architecture and common infrastructure
• Understands Global Development Clinical Development business domain and technology well and can analyze business challenges and present technology solutions.
• Partners with vendors in keeping abreast of technology trends and applicability to business needs.
• Functions as point of contact for support with Vault QMS
• Works with System Owners, Business Process Owners and end users in understanding business needs and designing creative solutions.
• UAT testing support coordination
• Ensures compliant change control per GXP procedures
• Establishes best practices in the support of systems, by producing work practices, operating manuals, functional analysis and job aids, etc.
• Must have excellent understanding of related technology and its capabilities as it related to business processes for Quality Events, CAPA, Deviations, Audit, Serious Breach
• Must be able to take on multiple assignments and work independently, with minimal supervision on task implementation.
• Complies with all SOPs that support GDS Operations

Job Requirements:

• Minimum 10 years' experience managing complex high-impact IT projects from start to finish and supporting and administrating Global Development Solutions
• Bachelor's degree, or equivalent work experience
• Understanding of process and procedures, such as SOPs, Work Instructions, Job Aides, etc.
• Ability to effectively manage multiple priorities with a sense of urgency
• Attention to detail and accuracy of work
• Strong knowledge of business analysis, system design and producing quality documentation
• Strong problem solving, technical writing, facilitation, communication and presentation skills
• Must be motivated, independent and self-sufficient. Able to receive an assigned task and see it through to completion with minimal supervision
• Strong knowledge of SDLC methodologies
• Strong knowledge of Google Cloud Platform and 21 CFR Part 11 Compliance
• Expert in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio)
• Experience with ServiceNow and Jira Experience on core ITIL processes