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Job Details

GMP Quality Program Manager

Company name
Takeda Pharmaceutical Company Limited.

Location
Boston, MA, United States

Employment Type
Full-Time

Industry
Manager, Quality, Chemistry, Engineering, Sciences

Posted on
Mar 24, 2020

Valid Through
Jul 07, 2020

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Job Description

OBJECTIVE:

This position ensures compliance with applicable regulations and Takeda Quality standards for GMP pharmaceutical operations related to manufacturing, testing, packaging, and distribution of investigational drug product and investigational active pharmaceutical ingredients (API).

The GMP Quality Manager is expected to independently manage projects and make sound decisions related to product quality issues.

ACCOUNTABILITIES:

Employ GMP QA expertise and principles during the development, manufacturing, testing, packaging and release of investigational API and drug product (collectively Clinical Trial

Material, CTM) to ensure product quality, solve project problems, significantly influence the compliance of projects/programs, and achieve business goals.

Provide strategic GMP quality/compliance guidance to internal stakeholders by serving as GMP QA authority on pharmaceutical development/CMC teams.

Provide strategic GMP guidance to third-party vendors to ensure quality and compliance of Takeda products.

Oversee and conduct final release and disposition of CTM for use in Takeda-sponsored studies.

Investigate product complaints through evaluation of batch record documentation and interactions with internal and external technical personnel.

Serve as GMP QA subject matter expert in the review and approval of stability protocols/reports, test method validations and specifications, as well as in the resolution of investigations, deviations, and out-of-specification investigations.

Lead comprehensive GMP Quality audits of current or new vendors in support of Takeda’s CTM supply chain. Make recommendations to management concerning the use of vendors based on audit findings.

Manage internal quality improvement initiatives: evaluate internal processes;

suggest/design/implement

improvements; create/revise relevant SOPs.

Support inspectional readiness activities at external vendors (e.g., manufacturers, packagers, and laboratories) related to Takeda regulatory submissions. Effectively interact with QA senior management and internal stakeholders to implement inspectional readiness strategies, assess potential risks, and determine necessary actions to mitigate risks.

Additional duties as assigned.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Education:

Bachelor’s Degree in Chemistry, Biology, Engineering or related field.

Experience may be substituted for Bachelor’s Degree: a) High School diploma/GED plus minimum of 10 years pharmaceutical manufacturing, packaging, or laboratory experience or b) Associate’s Degree plus minimum of 8 years pharmaceutical manufacturing, packaging, or laboratory experience.

Experience:

Minimum of 6 years pharmaceutical manufacturing, packaging, or laboratory experience

Including at least 4 years in GMP QA/QC/Compliance.

Experience with the pharmaceutical drug development process.

Track record of successfully working with third-party vendors.

Knowledge of the auditing process and experience conducting audits.

Behavioral Competencies and Skills:

Comprehensive knowledge of international GMP regulations and subsequent applications to pharmaceutical drug development.

Thorough understanding of

creation/review/approval

of GMP documents such as specifications, test methods, stability protocols, batch records, and investigations.

Demonstrated teamwork, initiative, and problem solving skills.

Strong oral/written communication skills.

Demonstrated project management skills.

LICENSES/CERTIFICATIONS:

Quality auditor certification preferred.

PHYSICAL DEMANDS:

Routine demands of an office based environment.

TRAVEL REQUIREMENTS:

Requires approximately 10% travel, both domestic and international.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID

R0017543

Company info

Takeda Pharmaceutical Company Limited.
Website : https://www.takeda.com

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