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

Role Summary

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, 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. Location: Lexington, MA; Hybrid work environment.

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.

Qualifications

• Required: 5+ years of increasing responsibility in manufacturing, QC/QA, or compliance.
• Required: Comprehensive understanding of international pharmaceutical regulations and their application to cGMP development activities.
• Required: Proven ability to critically review manufacturing documentation for compliance with procedures, regulations, and regulatory filings.
• Required: Strong problem-solving skills with the ability to anticipate issues and drive proactive, practical solutions.
• Required: Experience working effectively in global, matrixed environments with the ability to influence cross-functional stakeholders.
• Required: Excellent communication and interpersonal skills, with professional experience interacting with CMOs, suppliers, and testing labs.
• Required: Demonstrated ability to negotiate complex issues and reach constructive, compliant resolutions.
• Required: Ability to mentor, guide, and share expertise to strengthen team capabilities.
• Required: High attention to detail and solid organizational skills, with the ability to manage multiple priorities independently.

Education

• Bachelor’s degree in a relevant scientific field required; advanced degree preferred.

Skills

• Quality oversight and cGMP/compliance across R&D to manufacturing stages.
• Regulatory knowledge for international pharmaceutical regulations and regulatory filings support, including CMC.
• Documentation review and approval capabilities for batch records, specifications, analytical methods, and stability plans.
• CAPA management, deviation investigations, and corrective action planning.
• Audit readiness and SME contributions in external audits, PAI readiness, and supplier qualification.
• Collaboration with CMOs, suppliers, testing labs, and cross-functional teams to resolve quality events.
• Mentoring, coaching, and developing team capabilities; strong communication and negotiation skills.
• Strong problem-solving, organizational, and multitasking abilities with attention to detail.

Additional Requirements

• Willingness to travel approximately 10% domestically and internationally and to operate in both office and manufacturing/lab environments.