Takeda · 1 day ago
R&D Quality Laboratory Oversight (Associate Director)
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
7+ years expTakeda 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.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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
Qualification
Required
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
Preferred
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
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase