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Job Description

_OBJECTIVES/PURPOSE_

+ Provide global GxP Quality oversight of laboratory activities (method development, validation, release, stability) across modalities.

+ Ensure implementation and execution of data integrity and quality system standards in internal and external laboratories.

+ Partner with cross-functional teams to support analytical lifecycle management and regulatory submission readiness.

+ Lead key quality initiatives and investigations related to laboratory operations.

_ACCOUNTABILITIES_

+ Provide quality oversight for internal GxP and non-GxP laboratories performing analytical activities across the R&D pipeline.

+ Review and approve GMP/GLP documentation including method validation protocols/reports, deviations, CAPAs, and audit responses.

+ Ensure appropriate implementation of ALCOA+ principles and data integrity controls in laboratory systems and workflows.

+ Lead or support laboratory-related investigations and inspections, ensuring timely root cause analysis and sustainable CAPA.

+ Collaborate cross-functionally with Pharmaceutical Sciences, Regulatory Affairs, Manufacturing, and other Quality functions.

+ Participate in the preparation and review of analytical sections for regulatory filings (IND/CTA/NDA/BLA).

+ Contribute to the development and improvement of global procedures, standards, and quality frameworks for laboratory oversight.

+ Monitor quality performance trends and proactively escalate compliance risks or improvement opportunities.

_DIMENSIONS AND ASPECTS_

Technical/Functional (Line) Expertise

+ Strong understanding of GxP regulations, analytical methods, and laboratory operations across modalities (small molecules, biologics required; cell/gene therapy, plasma, or vaccines a plus).

+ Demonstrated application of data integrity principles and computerized system controls in laboratory environments.

+ Experience with internal and external laboratories, technical agreements, and audit preparation.

+ Proficiency in quality risk management, deviation handling, and CAPA effectiveness.

Leadership

+ Supports strategic goals of the R&D GMP Quality organization.

+ Coaches junior team members or cross-functional partners on quality principles.

+ Effectively communicates quality expectations and analytical requirements.

+ Influences decision-making in cross-functional settings and supports change management efforts.

Decision-making and Autonomy

+ Exercises judgment in resolving laboratory-related quality events and compliance issues.

+ Makes independent decisions within the scope of analytical QA responsibilities.

+ Provides recommendations for quality risk mitigation and system improvements.

Interaction

+ Collaborates with Analytical Development, QC, Manufacturing, Regulatory, and QA teams.

+ Interfaces with external laboratories and CMOs as required.

+ Participates in regulatory inspections, audits, and governance meetings.

Innovation

+ Contributes to process improvements and implementation of digital solutions.

+ Promotes knowledge sharing and continuous improvement culture within the team.

+ Identifies new tools or practices to enhance laboratory compliance and efficiency.

Complexity

+ Supports laboratory oversight across a range of modalities and global sites.

+ Navigates matrixed organizational structures and diverse cultural and regulatory landscapes.

+ Balances scientific, compliance, and business needs in decision-making.

• **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_**

+ Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field. Preferred advance degree (MS/PhD)

+ 7+ years of relevant industry experience in quality oversight of laboratory operations

+ Demonstrated experience in GMP/GLP, analytical testing, data integrity, and regulatory inspections

+ Strong interpersonal, project management, and problem-solving skills

+ Ability to operate in a global matrix environment and manage competing priorities

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

$153,600.00 - $241,340.00

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.

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, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full 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.