Oversees IT Compliance testing of new or modified applications/systems across multiple computing e nvironments. Applies IT and Compliance knowledge and experience to analyze requirements against test cases, reviewing and approving test cases. Leads the IT Compliance activities within a project or multiple projects within a single client area. Prepares and approves documentation per policy and procedure to support the certification of an application/system. Primary support to project and IT staff related to SLC, validation and compliance process and procedures.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Develops the testing strategy and architecture for medium to large projects.
Participate in the development and or modification of automated test scripts. Develops, reviews and approves system documentation (test plans/strategies, other SLC documentation) in support of validation activities.
Leads the development and execution of test plans. Communicates project progress by producing project reports to provide timely and accurate status to Project team. Performs work using standard methodologies, processes and tools to ensure IT Compliance.
Resolve issues that may delay the project or otherwise subject the company to financial or regulatory risk.
Establishes project tasks and timelines and is held accountable to them. Capture and report on IT Compliance data and metrics for assigned project tasks and identify potential process improvements.
Ensures IT Compliance tasks stay within project budget and/or estimates. Assists in the establishment of regulated policies and procedures at the departmental level. Establishes and maintains productive relationships with all levels in the Divisional IT organization, and business function.
Acts as a liaison and IT Compliance expert to assure successful implementations. Serves as a source of information on the IT Compliance needs and regulatory environment.
Monitors and coordinates the IT Compliance efforts within a project. Guides the efforts of less experienced staff. Independently conceives and develops general approaches to the solution of systems problems which require application of basic IT compliance principles. Errors or failure to achieve expected results may result in project delays and/or the expenditure of more resources or impact projects costs than was planned.
Interacts with functional groups at various management levels to gain cooperation, foster collaboration and influence project outcomes.
Facilitates validation activities within the team and cross-functional groups.
Ensures project tasks stay within project budget and/or time estimates.
Bachelors Degree or equivalent certification or experience. No advanced degree required.
4-6 years experience in a quality systems environment, or equivalent combined work experience. Excellent analytical, judgment and consultative capabilities and communication skills and the ability to work with both IT management and staff.
Good documentation skills
Strong communication skills
Strong work ethic
Flexible and adaptable to change
Ability to work independently and in groups
Strong compliance knowledge associated with a cGMP environment
Working knowledge/Strong familiarity of 21 CFR Part 11 and Data Integrity requirements for computerized systems, General Principals of Software Validation, and Electronic Records/Signatures