Computerized Systems Quality Assurance Lead

Objectives

Computerized Systems Quality Assurance (CS QA) Lead helps deliver on Takeda's commitments for patient Safety, Product quality and data integrity by ensuring the quality and regulatory compliance of computerized systems and regulated data. This is accomplished by providing independent oversight of computerized system validation and operational activities to confirm that computerized systems and regulated data are maintained in compliance with applicable Healthcare Laws and regulations, and Takeda policies and procedures. The CS QA Lead also drives and sustains improvements to computerized systems and the processes for implementing and supporting them.

Accountabilities

• Provides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.
• Promote and champion support of compliance, quality and best practice-oriented culture regarding Computerized systems.
• Authorize validation deliverables produced for global computerized system projects, including operational procedures, maintenance procedures and change requests
• Support the development of global CS QA related procedures
• Participate in ongoing operational management activities for global systems including, but not limited to demand management, Change Advisory Board and Quality Metrics
• Support qualification activities for global computerized system vendors and 3rd party software providers including Cloud providers and SaaS solutions.
• Provide expertise and support during audits and inspections of Takeda
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Proactively identify risks and issues. Drive implementation of pragmatic, Compliant, risk-based solutions
• Lead on-going initiatives and improvement projects in areas related to computerized systems and regulated data, as assigned
• Proactively identify and share emerging industry standards/trends with business partners in the area of regulated computerized systems and regulated data
• Support the response and remediation of corrective actions and internal audits.
• Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with Takeda procedures, regulatory requirements and industry standards.

Education, Experience, Knowledge and Skills

• Bachelor's degree in science, Business, Engineering, IT or related discipline or 5 years of equivalent professional experience.
• Minimum 5 years of experience with FDA Regulations, ICH, EMA and/or other international healthcare regulations.
• Minimum 5 years of experience working with regulated IT systems and IT teams
• Experience making quality assurance and compliance decisions in regard to software development, validation and support.
• Experience with all phases of software validation and infrastructure qualification.
• Experience with all phases of System Development Lifecycle principles, Processes and procedures.
• Demonstrated multitasking project management and execution skills
• Ability to influence & negotiate with teams from all levels of the organization and external suppliers.
• Ability to read, analyze and interpret business plans technical procedures, and government regulations
• Proven analytical and problem resolution skills; ability to identify root cause of problems
• Excellent verbal and written communication skills at the functional and technical level.
• Ability to understand complex business processes and recommend simplification where possible.
• Documented experience in working as part of a virtual team.
• Proficient in Microsoft Office products
• Willingness to travel to various meetings or Takeda sites, including overnight trips. Some international travel may be required. Requires approximately 5-10% travel.