[Remote] R&D Quality Laboratory Oversight (Associate Director)

Note: The job is a remote job and is open to candidates in USA. Takeda is a global biopharmaceutical company focused on transforming the lives of patients. The Associate Director will provide global GxP Quality oversight of laboratory activities, ensuring compliance with quality standards and leading key quality initiatives across the R&D pipeline.

Responsibilities

• 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

Skills

• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Advanced degree (MS/PhD)

Benefits

• Allowances Commutation, Housing, Overtime Work etc.
• Salary Increase Annually, Bonus Payment Twice a year
• 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.

Company Overview

• Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs. It was founded in 1781, and is headquartered in Tokyo, Tokyo, JPN, with a workforce of 10001+ employees. Its website is http://www.takeda.com.

Company H1B Sponsorship

• Takeda has a track record of offering H1B sponsorships, with 45 in 2025, 39 in 2024, 38 in 2023, 34 in 2022, 44 in 2021, 18 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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