Takeda · 18 hours ago
Principal Manager, R&D GMP Pharmaceutical Sciences Quality EU & US (hybrid)
Lexington, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$112K/yr - $176K/yr
5+ years expTakeda is a patient-focused company transforming patient care through the development of novel specialty pharmaceuticals. The Principal Manager, R&D GMP Pharmaceutical Sciences Quality will provide Quality oversight across investigational medicinal product development, ensuring compliance, product integrity, and collaboration with various stakeholders.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Oversee final release and disposition of Clinical Trial Material across multiple modalities and complex development programs
Review and approve batch documentation, master/executed records, labels, specifications, analytical methods, protocols, and stability plans
Ensure deviations, Out of Specification/Out of Trend, complaints, and other quality issues are fully investigated and addressed with effective CAPAs
Collaborate closely with Pharmaceutical Sciences, Global Clinical Supply Chain, and other partners to resolve quality events
Identify applicable regulations, assess compliance gaps, and propose solutions to maintain cGMP compliance
Serve as GMP QA authority for Pharm Science Teams and provide strategic quality guidance internally and to CMOs/partners
Support or lead continuous improvement initiatives that enhance R&D GMP Quality processes and operational efficiency
Contribute technical quality content to regulatory filings and collaborate with CMC submission teams
Participate as SME in external audits, support PAI readiness, and contribute to supplier qualification and Quality Technical Agreements
Build strong cross-functional relationships to enable agile pharmaceutical development and high-quality outcomes
Qualification
Required
Bachelor's degree in a relevant scientific field required; advanced degree preferred, with 5+ years of increasing responsibility in manufacturing, QC/QA, or compliance
Comprehensive understanding of international pharmaceutical regulations and their application to cGMP development activities
Proven ability to critically review manufacturing documentation for compliance with procedures, regulations, and regulatory filings
Strong problem-solving skills with the ability to anticipate issues and drive proactive, practical solutions
Experience working effectively in global, matrixed environments with the ability to influence cross-functional stakeholders
Excellent communication and interpersonal skills, with professional experience interacting with CMOs, suppliers, and testing labs
Demonstrated ability to negotiate complex issues and reach constructive, compliant resolutions
Ability to mentor, guide, and share expertise to strengthen team capabilities
High attention to detail and solid organizational skills, with the ability to manage multiple priorities independently
Willingness to travel approximately 10% domestically and internationally and to operate in both office and manufacturing/lab environments
Benefits
Short-term and/ or long-term incentives
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
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
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
2026-01-09
2026-01-08
Company data provided by crunchbase