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

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Job Description

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

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. 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. 

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, MA

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.