Posted to MedZilla on 3/25/2017


Takeda Pharmaceuticals

US-MA, GMP Quality Program Manager / Principal GMP Quality Program Manager Biologics 1700192-MZ


 
 

OBJECTIVES:
  • Actively Leads & manages strategic GMP QA activities associated with Takeda development programs
  • Ensures compliance with regulations & Takeda Quality Standards related to manufacturing testing, packaging & distribution of investigational drug product and investigational active pharmaceutical ingredients. Identifies compliance gaps and proposes solutions.
  • Independently manages projects & make sound decisions related to product quality issues
  • Mentors other members of the GIQ team

ACCOUNTABILITIES:

  • 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
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor Degree in Chemistry, Biology, Engineering or related field plus extensivepharma manufacturing, packaging or laboratory experience
  • Solid industry experience in GMP QA/QC/Compliance.
  • Comprehensive knowledge of international GMP regulations and subsequent applications to pharma drug development
  • Thorough understanding of creation/ review/approval of GMP documents such as specifications, test methods, stability protocols, batch records, and investigations Experience in QA of drug product through the lifecycle of pharmaceutical product development
  • Demonstrated teamwork, initiative and problem solving skills
  • Strong oral/written communication skills
  • High attention to detail
  • Demonstrated project management skills.
  • Proven ability to mentor and train other members of the GIQ team
  • Capable of analyzing a wide variety of information and data to make management decisions regarding potential risks associated with product quality or regulatory compliance.
  • Able to establish professional relationships and rapport with internal and external peers . Experience working on teams in a complex, matrixed and global environment.

TRAVEL REQUIREMENTS:

10% domestic and international



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