Hybrid CS QA Lead: Regulated Systems & Data Quality

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

Benefits offered by this job

Hybrid work model

Job summary

Takeda is seeking a Computerized Systems Quality Assurance (CS QA) Lead in Lexington, MA to ensure patient safety, product quality, and data integrity for regulated systems. You’ll provide independent oversight across validation, change management, and vendor qualification, promoting a culture of quality and compliance.

The role requires at least a bachelor’s degree or 5 years of equivalent experience, plus 5+ years in FDA/ICH/EMA-regulated environments and experience with all phases of software

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 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.

Responsibilities

• 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.

Skills

FDA Regulations

Regulated IT systems

Software validation

System Development Lifecycle

Analytical thinking

Education

Bachelor’s degree in science, Business, Engineering, IT

Tools

Microsoft Office

Job description

Takeda is seeking a Computerized Systems Quality Assurance (CS QA) Lead in Lexington, MA to ensure patient safety, product quality, and data integrity for regulated systems. You’ll provide independent oversight across validation, change management, and vendor qualification, promoting a culture of quality and compliance.

The role requires at least a bachelor’s degree or 5 years of equivalent experience, plus 5+ years in FDA/ICH/EMA-regulated environments and experience with all phases of software