JOB TITLE : Manager, Quality Assurance (small molecule)

Requisition Number	7496BR
Department Name	Investigational QA
Location	Cambridge, MA
Job Description	• The GMP Quality Manager leads and manages strategic GMP QA activities associated with Takeda’s pharmaceutical product development programs. • 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. The individual in this role will • 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. 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 Quality, Manufacturing, 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