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

BioSpace; Lexington (MA); On-site; USD 111,800 - 175,670; Full time

Job summary

A leading biopharmaceutical company is seeking a Principal Manager for R&D GMP Pharmaceutical Sciences Quality. This role ensures quality oversight in drug development and compliance with cGMP regulations. With a focus on collaboration and independent decision-making, the ideal candidate will have a relevant degree and experience in the pharmaceutical industry. Strong problem-solving and communication skills are essential. This position is based in Lexington, MA and includes attractive compensation benefits.

Qualifications

• 5+ years of increasing responsibility in manufacturing, QC/QA, or compliance.
• Comprehensive understanding of international pharmaceutical regulations.
• Ability to mentor and guide team capabilities.

Responsibilities

• Oversee final release and disposition of Clinical Trial Material.
• Collaborate with partners to resolve quality events.
• Serve as GMP QA authority and provide strategic quality guidance.

Skills

Problem-solving skills

Communication skills

Attention to detail

Organizational skills

Education

Bachelor’s degree in a relevant scientific field

Advanced degree preferred

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

About the role

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.

How You Will Contribute

• 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.

What You Bring To Takeda

• 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.

More About Us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering Our People To Shine

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

Takeda Compensation And Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location

Lexington, MA

U.S. Base Salary Range

$111,800.00 - $175,670.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MACHE - Glattpark (Opfikon) - Zurich HQ

Worker Type

Employee

Worker Sub‑Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.