Principal GMP Quality Manager


  • Boston, MA
  • Permanent
  • Full-time
  • 3 months ago
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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. Identify compliance gaps and propose solutions. Independently manage projects and make sound decisions related to product quality issues. Mentor other members of the GIQ team, and 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
  • 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
Empowering Our People to Shine

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Boston, MA

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Full time