Principal Manager, R&D GMP Pharmaceutical Sciences Quality EU & US (hybrid)

Takeda • Lexington, MA

8d • Hybrid

About The Position

The Principal Manager, R&D GMP Pharmaceutical Sciences Quality EU & US provides Quality oversight across Takeda’s investigational medicinal product development lifecycle, from early clinical development through commercialization. You will support diverse and often complex programs, including biologics, synthetic molecules, plasma-derived therapies, cross-modality conjugates, combination products, and new modalities. The role requires independent decision-making, strong cross-functional collaboration, and the ability to work with multiple CMOs and partnership organizations to ensure cGMP compliance, product integrity, and timely progression of development programs.

Requirements

• 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.

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.

Benefits

• U.S. based employees may be eligible to participate in 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, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees