The Senior Manager, Computerized Systems Validation & Quality Assurance is responsible for validation oversight to ensure the compliance, integrity, and reliability of computerized systems within the organization. This encompasses day-to-day operational management and project leadership with a focus on authoring, review, approval of system validation, infrastructure qualification documentation, and execution of protocols where applicable, in accordance with pharmaceutical industry regulations, guidelines, GAMP, latest industry practices and Shionogi processes.
The senior manager collaborates with cross functional teams to facilitate successful system implementations, supports, or drives continuous improvement initiatives, ensures regulatory compliance, and fosters a culture of innovation and efficiency. Working in tandem with the CSV leadership team this role contributes to the broader organizational strategy, influencing decisions at the operational level and supporting the development of the overall validation and quality strategy. Ultimately, the senior manager is responsible for maintaining and advancing the quality and compliance standards of computerized systems across assigned projects.
The following job duties are not all-inclusive and additional responsibilities may be added to the role as needed. The duties and responsibilities listed are intended to provide a general overview of the position and may change over time based on the needs of the organization.
Minimum Job Requirements
Essential Physical Requirements
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
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