• Performing computer system validation activities according to regulatory requirements and relevant local procedures• Developing and executing validation documentations for new and updated systems• Conducting risk assessments to identify and mitigate potential compliance risks associated with GMP systems• Facilitating cross-functional team collaborations, including Quality Assurance, Business System Owners, Technical System Owners, to ensure alignment of validation activities with project timelines and objectives

• A program manager in Right-to-Operate and Operation Excellence within the organization to oversee quality record (DEV/CAPA) investigation and assessment, and leading the team in continuous improvements• Leading the team in establishment of validation standards for qualification and data integrity remediation of analytical instrument and controlling computer systems, such as Waters UPLC, and BioTek Multi-Mode Plate Reader and Gen5 Software, Perkin Elmers EnVision Plate Reader and Softmax Pro Analysis Software, BD FACSCanto Flow Cytometer and DIVA Software, etc.• Develop and execute qualification testing protocols for cGMP critical equipment/system validation with qualification document in respect to GAMP5 principles and data integrity requirements• Responsible for facilitating User Requirements Specification development process related to compliance and applicable regulations and guidelines• Highly skilled and experienced in developing and executing chamber temperature mapping using data logger• Responsible in day-to-day coordination of facility expansion projects for GMP operation• Communicate with project managers regarding specific study development activities• Provide project status information of the ongoing qualification activities and data to project council and managements • Responsible for project specific quality documents management, such as standard operation procedures (SOPs), work plans, training guides, etc. related to the validation testing activities

•Verification of punch list completion post-System Installation Completion•Coordination of client, contractor, vendor and verification project team resources required to support verification execution activities•Verification Protocol and Report geneation •Execution of Site Verification Protocols at the Bothell site•Documenting and resolving deviations during Site Verification•Completing, and facilitating the review and approval of each Release-For-Use (RFU) form

•Day-to-day management of clinical projects.•Participate in the design and review of study protocols, case report forms (CRFs), associated study documents, monitoring plans, and regulatory submissions and reports in collaboration with clinical management. •Coordinate clinical data monitoring and database activities via a key relationship with the Clinical Data Manager. •Serve as an operational resource for internal team members for expedited problem identification and resolution, provision of site-specific updates and investigator activities, and CRO interactions and deadlines. •Provide regular clinical status information and to team members, including attending required meetings and following-up on action items. •Ensure adherence to protocols, procedures, and project plans. •Participate in identification, evaluation, and selection of investigative sites. •Assists and/or manage activities and interactions with CROs and/or vendors. •Maintains all relevant documentation and communications as part of study files. •Performs other job related duties as assigned. •Coordinates clinical site monitoring activities, and may participate in site monitoring associated with initiation, interim, close out, and audit visits as required. •Adhere and assists with clinical operations and project specific quality documents (for example: SOPs, work plans/practices, training guides). •Reviews study data and resolution of queries, compile data for data review, create tables and graphs under appropriate guidance, and assist with the preparation and review of clinical study reports.

•Held key responsibilities in Day-to-day coordination of clinical and pre-clinical projects•Assisted in timeline management, contacting CROs and third vendors and coordinating clinical project team meeting and other project related activities•Worked with contracts and budgets for clinical and pre-clinical projects from project development through study close-out•Assisted clinical project team members in the development of the clinical and pre-clinical research protocols and in the evaluation of results•Conferred with clinical project team leader regarding individual aspects of the specific project management•Assisted with clinical operations and project specific quality documents (for example: SOPs, work plans/practices, training guides)