Senior CS QA Lead: Drive Safe, Compliant Regulated Systems

Regulatory Jobs; Lexington (MA); Híbrido; USD 116.000 - 182.000; Jornada completa

Descripción de la vacante

Takeda is seeking a Computerized Systems Quality Assurance Lead in Lexington, MA. You will provide independent oversight to ensure computerised systems stay compliant with FDA/ICH/EMA requirements and Takeda policies, driving quality improvements and risk-based actions across global projects.

You will collaborate with IT, vendors, and stakeholders to authorize validation deliverables, support global CS QA procedures, and lead initiatives while traveling up to 5-10% as needed.

Formación

• Bachelor’s degree in science, business, engineering, IT 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 with regulated IT systems and IT teams.
• Experience making quality assurance and compliance decisions in 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 levels and external suppliers.
• Ability to read, analyze and interpret business plans, technical procedures, and government regulations.
• Analytical and problem resolution skills; ability to identify root causes.
• Excellent verbal and written communication at functional and technical levels.
• Ability to simplify complex business processes where possible.
• Experience working as part of a virtual team.
• Proficient in Microsoft Office products.

Responsabilidades

• Provides independent oversight to assure compliance of computerized systems with quality procedures and regulations.
• Promote a culture of compliance and best-practice in computerized systems.
• Authorize validation deliverables for global projects including procedures and change requests.
• Support the development of global CS QA related procedures.
• Participate in ongoing operational management activities for global systems.
• Support qualification activities for global vendors and 3rd party providers.
• Provide expertise during audits and inspections of Takeda.
• Identify and report quality or compliance concerns and take corrective actions.
• Identify risks and drive pragmatic, compliant risk-based solutions.
• Lead initiatives in areas related to computerized systems and data.
• Share emerging industry standards with business partners.
• Support remediation of corrective actions and internal audits.
• Collaborate with IT, Vendors, Quality SMEs and Owners to ensure activities align with Takeda procedures.

Conocimientos

Quality Assurance

Regulatory compliance

Project management

Influence & negotiation

Analytical thinking

Educación

Bachelor’s degree in science, engineering, IT or related

Herramientas

Microsoft Office

Descripción del empleo

Takeda is seeking a Computerized Systems Quality Assurance Lead in Lexington, MA. You will provide independent oversight to ensure computerised systems stay compliant with FDA/ICH/EMA requirements and Takeda policies, driving quality improvements and risk-based actions across global projects.

You will collaborate with IT, vendors, and stakeholders to authorize validation deliverables, support global CS QA procedures, and lead initiatives while traveling up to 5-10% as needed.