Computerized Systems Quality Assurance Lead

Takeda

6d•$116,000 - $182,270•Hybrid

About The Position

The Computerized Systems Quality Assurance (CS QA) Lead provides independent oversight of computerized system validation and operational activities to help ensure patient safety, product quality, and data integrity. The role ensures that computerized systems and regulated data comply with applicable healthcare laws and regulations, as well as Takeda policies and procedures. The lead also drives improvements to computerized systems and the processes used to implement and support them. The position oversees global computerized system projects and operations, including validation deliverables, procedures, change requests, vendor qualification, and operational management activities. It supports audits, inspections, corrective actions, and internal audits, while identifying risks and promoting pragmatic, risk-based compliance solutions. The role works with IT, vendors, Quality SMEs, and Business System Owners, and shares relevant industry standards and trends with business partners. This is a regular, full-time employee position classified as hybrid. It is based in Lexington, Massachusetts, with an additional location listed in Glattpark (Opfikon), Zurich, Switzerland. Travel of approximately 5–10% is required, including potential overnight trips and some international travel. The U.S. base salary range for Lexington is $116,000–$182,270.

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.
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 simplifications 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 is required.

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 development of global CS QA procedures.
Participate in operational management of 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 implementation of pragmatic, compliant, risk-based solutions.
Lead assigned initiatives and improvement projects related to computerized systems and regulated data.
Identify and share emerging industry standards and trends related to regulated computerized systems and regulated data.
Support responses to and remediation of corrective actions and internal audits.
Collaborate with IT, vendors, Quality SMEs, and Business System Owners to ensure work aligns with Takeda procedures, regulatory requirements, and industry standards.