Computerized Systems Quality Assurance Lead

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

Job summary

Takeda in Lexington, MA is seeking a Computerized Systems Quality Assurance (CS QA) Lead to ensure the quality and regulatory compliance of computerized systems and regulated data. You will provide independent oversight of validation activities and drive improvements across global projects.

The role requires 5+ years of experience with FDA/ICH/EMA regulations, experience with regulated IT systems, and strong communication skills. Some international travel is expected up to 5-10%.

Qualifications

• Bachelor’s degree in science, business, engineering, IT or related field (or 5 years equivalent professional experience).
• Minimum 5 years of FDA/ICH/EMA regulatory experience.
• Experience with regulated IT systems and IT teams.
• Experience with software validation and lifecycle.
• Ability to read and interpret regulations.
• Strong communication and documentation skills.
• Willingness to travel 5–10%.

Responsibilities

• Provide independent oversight to assure CS are compliant with quality procedures and regulations.
• Champion a culture of quality and compliance for computerized systems.
• Authorize validation deliverables for global CS projects.
• Support development of global CS QA procedures.
• Participate in Change Advisory Board and Quality Metrics activities.
• Support qualification of global CS vendors and SaaS providers.
• Provide expertise during audits and inspections.
• Identify and report quality/compliance concerns and take corrective action.

Skills

Quality Assurance

Regulatory Compliance

Software Validation

Risk Management

Project Management

Communication

Education

Bachelor’s degree or 5 years experience

Tools

Cloud Providers

SaaS Solutions

MS Office

Job description

Job Description

OBJECTIVES:

Computerized Systems Quality Assurance (CS QA) Lead helps deliver on Takeda´s commitments for patient Safety, Product quality and data integrity by ensuring the quality and regulatory compliance of computerized systems and regulated data. This is accomplished by providing independent oversight of computerized system validation and operational activities to confirm that computerized systems and regulated data are maintained in compliance with applicable Healthcare Laws and regulations, and Takeda policies and procedures. The CS QA Lead also drives and sustains improvements to computerized systems and the processes for implementing and supporting them.

ACCOUNTABILITIES:

• 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.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

• 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.


• Demonstrated multitasking project management and execution skills


• Ability to influence & negotiate with teams from all levels of the organization and external suppliers.


• Ability to read, analyze and interpret business plans technical procedures, and government regulations


• Proven analytical and problem resolution skills; ability to identify root cause of problems


• Excellent verbal and written communication skills at the functional and technical level.


• Ability to understand complex business processes and recommend simplification where possible.


• Documented experience in working as part of a virtual team.


• Proficient in Microsoft Office products

Willingness to travel to various meetings or Takeda sites, including overnight trips.

Some international travel may be required.

Requires approximately 5-10% travel.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as \"hybrid\" in accordance with Takeda's Hybrid and Remote Work policy.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$116,000.00 - $182,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MACHE - Glattpark (Opfikon) - Zurich HQ, Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.