Computerized Systems Quality Assurance Lead

3345 Takeda Manufacturing U.•Lexington, MA

5d•$116,000 - $182,270•Hybrid

About The Position

The Computerized Systems Quality Assurance (CS QA) Lead helps deliver Takeda’s commitments to patient safety, product quality, and data integrity. The role provides independent oversight of computerized system validation and operational activities to ensure that computerized systems and regulated data comply with applicable healthcare laws and regulations, as well as Takeda policies and procedures. The lead also drives and sustains improvements to computerized systems and the processes used to implement and support them. The position works with global system projects and operational teams, vendors, IT, Quality SMEs, and Business System Owners. It supports audit and inspection readiness, risk-based compliance solutions, corrective actions, and continuous improvement initiatives. The role is classified as hybrid and requires approximately 5–10% travel, including possible overnight and international trips.

Requirements

Bachelor’s degree in science, business, engineering, IT, or a related discipline, or five years of equivalent professional experience.
At least five years of experience with FDA regulations, ICH, EMA, and/or other international healthcare regulations.
At least five years of experience working with regulated IT systems and IT teams.
Experience making quality assurance and compliance decisions related 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 and negotiate with teams at all organizational levels and with external suppliers.
Ability to read, analyze, and interpret business plans, technical procedures, and government regulations.
Proven analytical and problem-resolution skills, including root-cause identification.
Excellent verbal and written communication skills at functional and technical levels.
Ability to understand complex business processes and recommend simplification where possible.
Documented experience working as part of a virtual team.
Proficiency in Microsoft Office products.
Willingness to travel to meetings or Takeda sites, including overnight trips; some international travel may be required. Approximately 5–10% travel.

Responsibilities

Provide independent oversight to ensure computerized systems are selected, implemented, and maintained in compliance with quality procedures, regulations, and guidelines.
Promote a culture focused on compliance, quality, and best practices for computerized systems.
Authorize validation deliverables for global computerized system projects, including operational and maintenance procedures and change requests.
Support the development of global CS QA procedures.
Participate in operational management activities for global systems, including demand management, Change Advisory Board activities, and quality metrics.
Support qualification of global computerized system vendors and third-party software providers, including cloud providers and SaaS solutions.
Provide expertise and support during Takeda audits and inspections.
Identify and report quality or compliance concerns and take corrective action as required.
Identify risks and issues proactively and drive pragmatic, compliant, risk-based solutions.
Lead assigned initiatives and improvement projects involving computerized systems and regulated data.
Identify and share emerging industry standards and trends related to regulated computerized systems and data with business partners.
Support responses to and remediation of corrective actions and internal audits.
Collaborate with IT, vendors, Quality SMEs, and Business System Owners to ensure activities meet Takeda procedures, regulatory requirements, and industry standards.