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Principal GMP Quality Manager

Boston, Massachusetts

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Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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Principal GMP Quality Manager

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Job ID R0023051 Date posted 02/25/2021 Location Boston, Massachusetts

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as a Principal GMP Quality Manager in our Boston office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Principal GMP Quality Manager working on the R&D Quality team, you will be empowered to actively lead and manage strategic GMP QA activities with Takeda development programs, ensure compliance with regulations & Takeda Quality Standards related to manufacturing testing, packaging, & distribution of investigational drug product and investigational active pharmaceutical ingredients. You will also be accountable to Identify compliance gaps and propose solutions, independently manage projects and make sound decisions related to product quality issues, and mentor other members of the GIQ team. A typical day will include: 

  • QA lead on the CMC teams who Independently manages product projects , as assigned or initiated.
  • Provides support to CMC teams (or other development-related teams) as GMP QA authority, where needed – and may serve as SME on these teams.
  • Will execute and lead other staff to implement robust Phase-Appropriate QA guidance/review/approval for Product Development projects in Phase 1, 2 and 3.
  • Provide QA expertise or guidance to local or regional QA counterparts.  Monitors and evaluates industry regulations  on a regular basis for impact to CMCC GMP QA, and communicates to local/regional GMP QA.
  • Support process to transfer compound-specific quality knowledge gained during the drug development process to the appropriate Takeda commercial-product QA organization(s).
  • Inputs and ensures all relevant information from related programs are up to date
  • Identifies any trends related to development compounds, operations, etc.
  • Ensures timely submission of GMP-related documentation and archival
  • May lead comprehensive GMP quality audits of vendors as necessary.  Make recommendations to management concerning use of vendors based on audit findings.
  • Identifies any relevant trends with the vendor and communicates to management
  • Provides project specific input for Periodic Business Reviews with Vendor and may represent GMP Operations in PBR meetings
  • Oversees and may conduct final release and disposition of CTM for use in Takeda sponsored studies
  • Significantly leads Key initiatives, either as SME team member, or as team leader and/or project management leader
  • May co-lead initiatives to support and develop more junior peers
  • Manage internal initiatives, evaluate processes & make recommendations for improvements; create/revise SOPs
  • Evaluates, ensures execution and implementation, or facilitates regional or global  communication of any initiatives, or changes for impact. 
  • Ensures all relevant project information is accessible and prepared for audit review
  • Support inspection readiness activities at external vendors related to Takeda submissions.  Effectively interact with GIQ Senior Management and internal stakeholders to implement inspectional readiness strategies, assess potential risks, and determine necessary actions to mitigate risks
  • Provides QA support for regulatory filings, as necessary
  • Strategic lead  on more complex regional or global QA investigations
  • Evaluates, ensures execution and implementation, or facilitates regional or global  communication of any initiatives, or changes for impact.
  •  GMP QA SME in review & approval of stability protocols/reports, test method validations and specifications, as well as resolution of investigations, deviations and out-of-spec

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Education:

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

Experience:

  • Minimum of 5 - 8 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.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

This job posting excludes CO applicants.

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0023051
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