R&D Quality Laboratory Oversight (Associate Director) at Takeda Pharmaceutical Company Limited USA

Fujisawa, , Japan -

Full Time

Start Date

Immediate

Expiry Date

18 Jan, 26

Salary

0.0

Posted On

20 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GxP Regulations, Analytical Methods, Laboratory Operations, Data Integrity, Quality Risk Management, Deviation Handling, CAPA Effectiveness, Project Management, Problem-Solving, Interpersonal Skills, Leadership, Communication, Regulatory Compliance, Process Improvements, Digital Solutions, Quality Oversight

Industry

Pharmaceutical Manufacturing

Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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. Preffered 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 Employee Signature: Date: Manager Signature: Date: Takeda Compensation and Benefits Summary: Allowances: Commutation, Housing, Overtime Work etc. Salary Increase: Annually, Bonus Payment: Twice a year Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45 Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year) Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave. Flexible Work Styles: Flextime, Telework Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc. Important Notice concerning working conditions: It is possible the job scope may change at the company’s discretion. It is possible the department and workplace may change at the company’s discretion. Locations JPN - Kanagawa - Fujisawa Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

Provide global GxP Quality oversight of laboratory activities and ensure implementation of data integrity and quality system standards. Collaborate with cross-functional teams to support analytical lifecycle management and lead key quality initiatives related to laboratory operations.