Hybrid CS QA Lead: Regulated Systems & Compliance

Takeda Pharmaceutical Company Limited; Lexington (MA); Hybrid; USD 116,000 - 182,000; Full time

Job summary

Takeda Pharmaceutical Company Limited is seeking a Computerized Systems Quality Assurance (CS QA) Lead in Lexington, MA. The role ensures patient safety, product quality and data integrity by supervising validation and operational activities for computerized systems in compliance with healthcare laws and Takeda policies.

The CS QA Lead drives improvements, supports global CS QA procedures, and collaborates with IT, vendors, and business owners to meet regulatory requirements.

Qualifications

• Experience with FDA Regulations, ICH, EMA or other international healthcare regulations.
• Experience working with regulated IT systems and IT teams.
• Ability to influence and negotiate with teams across the organization.

Responsibilities

• Provide independent oversight to ensure computerized systems comply with quality procedures and regulations.
• Promote compliance and best-practice culture for computerized systems.
• Authorize validation deliverables for global CS projects and maintenance procedures.

Education

Bachelor's degree in science, Business, Engineering, IT or related discipline

5 years of equivalent professional experience

Tools

Microsoft Office

Job description

Takeda Pharmaceutical Company Limited is seeking a Computerized Systems Quality Assurance (CS QA) Lead in Lexington, MA. The role ensures patient safety, product quality and data integrity by supervising validation and operational activities for computerized systems in compliance with healthcare laws and Takeda policies.

The CS QA Lead drives improvements, supports global CS QA procedures, and collaborates with IT, vendors, and business owners to meet regulatory requirements.