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Job Description

Job Title: Data Systems Quality Lead Sr. Manager

Location: Cambridge, MA

About the role:

As a Data Systems Quality & Compliance Leader, you will support Quality oversight in the Validation/Qualification of Computerized Systems used by Research & Development (R&D). You will partner with R&D Technology and Business stakeholders to ensure Computerized Systems used in R&D are designed, developed, validated/qualified and implemented in compliance with internal processes and agency regulations (GxP requirements, 21 CFR Part 11/Annex 11/GAMP 5) and maintained in a compliant state throughout the lifecycle. You will report to the Head of Data Systems Quality.

How you will contribute:

Provide oversight support in the development, implementation, and upkeep of Quality Assurance programs and activities for R&D computerized systems used in regulatory applications, ensuring compliance with domestic and international standards.

Collaborating with our internal teams and external entities, including Contract Research Organizations (CROs), expert consultants, and suppliers, to ensure Computerized Systems used to support Takeda services comply and maintained in compliance state throughout the lifecycle, with internal processes and agency regulations (GxP requirements, 21 CFR Part 11/Annex 11/GAMP 5).

Collaborate with Digital Data & Technology and R&D to promote best practices to implement and maintain Computerized Systems in a compliant state. Leading information sessions with Global R&D Technology and Business stakeholder to promote the discussion and evaluation of best practices for enhancing quality and compliance of Computerized Systems.

Lead investigations in Computerized Systems compliance issues, quality incidents and risks within the organization and external partners.

Participate in health authority inspections, partner audits and internal audits.

Work with R&D partners in preparing for regulatory inspections by ensuring that supplier assessments, validation packages, and periodic reviews are completed and documented. Be the primary company representative and Subject Matter Expert (SME during global R&D agency inspections.

Achieve compliance goals through influence, advise, and cultivation of working relationships with global R&D stakeholders.

Develop and/or review all regulatory agency inspection responses and corrective action commitments related to Computerized System Validation (CSV) requirements, ensuring accurate and complete responses.

Provide Quality Assurance oversight by participating in Computerized System Validation Projects that support R&D efforts.

Assess computerized system change controls and ensure comprehensive testing and documentation are maintained.

Contribute to the audit program for assessing computerized system suppliers and external hosting providers by participating in the description of the system’s intended use, classification, and identification of supplier services.

Implement and uphold a periodic review system to ensure computerized systems remain validated and compliant with Procedural Documents and domestic/international regulations.

Manage compliance measurement programs by establishing metrics for critical quality endpoints and provide periodic reports to management with recommendations for ongoing quality improvements.

Collaborate with DD&T and R&D to enhance and maintain processes and procedures supporting computerized system validation requirements.

Through information sessions and/or forums communicate Data Systems Quality goals to teams within R&D and throughout the Takeda organization (Corporate/Enterprise-wide).

What you bring to Takeda:

Bachelor's degree in life sciences or computer sciences required; a master's degree in management or scientific discipline is advantageous.

Minimum of 6 years in the pharmaceutical industry.

Experience in computerized system lifecycle development, validation and oversight for R&D.

Experience leading cross-functional teams, advising on compliance-related issues, and influencing senior leaders.

Knowledge of regulatory requirements and standards for using computerized systems (21 CFR Part 11, EU Annex 11, GAMP 5).

Familiarity with GCP/GLP/GVP/GDP regulations as applied by FDA, EMA, MHRA, HC and PMDA.

Good technical writing skills. Write quality positions, audit reports, and SOPs.

Knowledge of MS Word, Excel, PowerPoint, SharePoint, Outlook, and Power Apps.

Experience with the drug development processes; clinical, non-clinical, pharmacovigilance, and regulatory affairs would be ideal.

Proficiency in applying validation protocols, complex validation processes and advising partners.

Understand goals and processes across R&D and corporate functions and recognizing when escalation is necessary.

Requires 10-20% domestic and international travel. Must travel globally to locations where R&D functions and activities exist.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

Work in a cold, wet environment.

Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

#GMSGQ

#ZR1

#LI-MA1

#LI-Hybrid

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:

Boston, MA

U.S. Base Salary Range:

$133,000.00 - $209,000.00

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. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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.

LocationsBoston, MALexington, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

It 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.