Senior Manager Data Quality Assurance, Data & Analytics
Otsuka Pharmaceutical

Job Info

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Position Summary

The Senior Manager Data Quality Assurance role in Data & Analytics (D&A) will have end-to-end accountability to the testing & qualification for GxP and Non GxP system validations in support of the Data Technologies & Analytics Enablement (DT&AE) function within D&A.

The Data Quality Assurance Senior Manager will have the responsibility to establish and implement quality management practices and operating model in support of Data Technologies & Analytics Enablement products. This role will be accountable to execute and monitor the testing and qualification activities in compliance with all associated validation requirements per Otsuka Global Standard Operation Procedures (GSOP) in CSV (Computer System Validation). This role will establish and provide oversight to a vendor-based team, setting expectations by providing objectives and requirements as well as managing performance through SLAs.

This role will represent DT&AE in internal and external audits, addressing any gaps and follow through the CAPA process. This will be a dynamic role involving testing management, collaborating with internal D&A teams and external partners, developing testing roadmaps, establishing best practices, and incorporating agility in ST (System Testing), SIT (System Integration Testing) & OQ (Operation Qualification) testing process.

Key Job Responsibilities

• End-to-End ownership of testing & qualification; test automation; functional and non-functional testing; and validation compliance requirement across Data and Analytics groups.
• Testing & Qualification: Manage testing & qualification across all Data & Analytics by identifying the demand, estimation/resource management, delivering the services with the defined metrics.
• Test automation & process management: Manage the test automation capability by identifying appropriate candidates for test automation, planning, delivering, and monitoring quality of deliverables. Also continue to improve the automation framework and necessary tool sets. Author and Manage Data Technologies Job aid specific to Testing & Qualification across all Otsuka Job aids according to Global SOP
• Functional Testing Services: Acquiring domain-based knowledge for inhouse application(s), verifying quality of the product, perform positive/negative testing and verifying edge/boundary conditions to avoid unknown scenarios in production version.
• Non-Functional Testing Services: Identify opportunity to implement & delivery the Non-Functional testing services like performance testing, test data management, accessibility testing services and mobile test lab/automation.
• Ability to develop and drive implementation of plans within budgets and timelines.
• Responsible for developing and maintaining strong relationships within D&A and other functions as well as with external partners. Able to manage vendor performance while maintaining a productive and effective relationship achieving desired outcomes.
• Effectively communicates in a remote/virtual environment; Communicates in an open, balanced and objective manner.
• Demonstrates flexibility and approaches process changes, technology and new responsibilities with an open curious mind.
• Models positive behaviors such as re-examining how things are done and challenging assumptions about what is possible.
• Demonstrates a balance of innovation and curiosity with discipline and structure. Is a champion of value-add change and evolution.
• Balances a focus on both, execution methods as well as outcomes.
• Works creatively within predefined standards.

Knowledge, Skills, Competencies, Education, and Experience

• Bachelor's degree in Computer Science or equivalent is required.
• Minimum 10+ years of Testing related experience is required.
• Strong understanding of GxP and Non-GxP processes of CSV systems.
• Minimum of 3+ years of experience in pharmaceutical industry.
• STLC (Software Testing Life Cycle) methodologies including Agile Testing & Validation in Pharma Industry
• Strong knowledge is Test Automation & Testing metrics
• Experience in managing FSP/MSPs (Managed Service providers) and/or contract workers for the outcome-based testing services
• Experience in representing in Internal & External: System Audit - JSOX
• Proficiency using collaboration tools, like Office 365 or similar
• Ability to communicate effectively with all levels of the organization.
• Strong negotiation and collaboration skills
• CAPA Management

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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