Senior CS QA Lead — Regulated Systems & Compliance

USA - 3345 Takeda Manufacturing U.S.A., Inc; Lexington (MA); Hybrid; USD 116,000 - 182,000; Full time

Job summary

Takeda in Lexington, MA is seeking a CS QA Lead to provide independent oversight of computerized system validation and regulated data, ensuring compliance with FDA, ICH, EMA and Takeda policies. This role drives quality improvements and risk-based solutions across global projects and partners.

You will collaborate with IT, vendors and business system owners, lead validation deliverables, support audits, and promote a culture of quality and compliance.

Qualifications

• 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 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.

Responsibilities

• Provides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.
• 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 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.
• Collaborate with IT, Vendors and Business System Owners to ensure activities are performed in line with Takeda procedures, regulatory requirements and industry standards.

Skills

FDA Regulations experience

IT/system validation

Quality Assurance decision-making

Cross-functional collaboration

Project management

Education

Bachelor’s degree or equivalent

Tools

Microsoft Office

Validation tools

Job description

Takeda in Lexington, MA is seeking a CS QA Lead to provide independent oversight of computerized system validation and regulated data, ensuring compliance with FDA, ICH, EMA and Takeda policies. This role drives quality improvements and risk-based solutions across global projects and partners.

You will collaborate with IT, vendors and business system owners, lead validation deliverables, support audits, and promote a culture of quality and compliance.