Validation Lead

OBJECTIVES:

• Lead and manage validation projects. This role coordinates, supports and assists all aspects of a computerized systems validation project from original concept through the final implementation.

• Develops project budgets and manages performance against financial parameters

ACCOUNTABILITIES:

• The validation project manager will lead the overall validation activities on the project, and provide subject matter expertise in the area of computerized systems validation.

• Lead and manage the overall validation testing activities and the validation testers on the project.

• Support the development and execution of validation test scripts, user acceptance test scripts, IQs, OQs, and PQs.

• Develop the overall project validation plan, validation report, and other validation life cycle documents. Assures quality, timeliness and effectiveness of deliverables while providing accurate status information to customers and IS/IT Leadership.

• Assist in the development of computer systems validation policies and standards.

• Participate in risk assessment exercises in support of validation activities, and perform periodic reviews.

• Maintain knowledge and comprehensive understanding of relevant pharmaceutical regulations and current interpretations affecting computerized systems validation.

• Represent Client during FDA or other regulatory agency inspections involving computer validation, electronic record/electronic signature, and data integrity.

• Initiate process improvements to reduce software development, acquisition, and validation costs and cycle times.

• Participate in the development of an audit plan for internal computer systems and external vendors and sites focused on the quality of the electronic data, systems, or services. This can be accomplished independently, or in support of other functions.

• Participate in the development and implementation of strategies, processes, tools and techniques to identify areas for improvement within the electronic data, systems, and services environment, and implement action plans for implementing improvements.

• Ensure that comprehensive software vendor audit assessments are performed for newly identified or current, regulated software vendors.

• Assure projects / requests are appropriately prioritized and aligned with the strategy and direction of the organization and appropriate resources are allocated for their development.

• Manages relationships with multiple vendors.