Senior External Site Lead (Burlington)


: $94,360.00 - $141,170.00 /year *

Employment Type

: Full-Time


: Government

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*Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info.

Every day, employees working in Takedas 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.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.


What makes a successful member of our team? Check out the traits were looking for and see if you have the right mix.

Job ID R0010512 Date posted 07/29/2019 Location Lexington, Massachusetts

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior External Site Leader in our Lexington, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.


Ensure the uninterruptedsupplyofdrug product andfinished goods from external suppliers which meet all quality requirements to support the small molecule market demands in theregionand countries being supplied from suppliers in theregion. Develop regional supplychain strategies, manage suppliermetrics and projects in the region. This will be accomplished throughplanning and on-time execution of strategic projects,commercialization plans, commercial CMC support,QA initiatives, anddeveloping/implementingsupplier managementstrategies. The scope of this role includes responsibility for the following activities:

  • External supplier management fordrug product and finished goods for thefull small moleculeportfolio,includingOncology,in partnership with Procurement
  • Coordinate team activities forlaunches forsmall moleculeand Oncologyfrom suppliersintheregion
  • Continuousimprovement strategy and executionforsuppliers in collaboration with the operating unit
  • Organizetechnicalservices supporting product improvements andtechnical/QA relatedissue resolutionat external suppliers for bulk product and finished goods.
  • Lead and manage the strategic and operational performance of external supplierswith direct responsibility foroperations andpartnership with theQuality and functionalbusiness partners to ensure the successful delivery of business strategy,keyperformanceindicators (KPIs) and objectives
  • Anticipate roadblocks, both intellectual and political, and proactively address issues before they impact business results
  • Use expertise to influence strategy, planning, manufacturing and supply chain processes
  • Establishaprocess for periodicreview and dissemination of informationthat represents the health of thesupplier and performance against KPIsto key leaders and stakeholders
  • Support site selection process to ensure consistency with commercial strategy
  • Maintain senior level communication lines with allsources of demand and supply
  • Lead the External Site Operations Team, accountable for commercial product supply,NPIs, technology transfers, CDMO management and strategy.
  • Acts independently or as a leader for a team ofTakedaKey Account Manager with CDMOs by serving as the primary point of contact.
  • Lead tactical and strategic sourcing studies, and provide our Operating Unit with structured analyses and strong business cases to support site selection decisions
  • Represent the voice of the CMOs in internal discussions.
  • Lead the cross-functionalExternalSite Operations Team (co-leadthe Joint Operations Team with CDMO) tomanagequalityperformance and end to endsupplyofTakedaproductsattheContractManufacturer(s)
  • Develop and execute Business Continuity Planning and any resulting Remediation/Risk Mitigation Plan for respective Contract Manufacturer(s)
  • Developbothshort-termand long-termplanswith theContractManufacturer(s) anddevelopbusinesscasestosupportand monitorexecutionthroughtheContinuousImprovementMaster Plan
  • Workingwith theExternalSite Operations Team,responsibleforproactiveidentificationofcontinuousimprovementopportunities(inclusive ofcostreductioninitiatives)
  • In partnership with Finance,responsibleforcreationandexecutionofapprovedstandardcostbudget forContractManufacturer(s)spend. Ensurecompliantexecutionof thefinancialworkflowthroughTakedaand CMsystems
  • RepresenttheExternalSite Operations Team andCDMOsasaleadcontributor to therespectiveOperating Unit and Technical Operations Product Teams fordevelopmentandimplementationofsourcingstrategiesandeffectivemanagement ofourCDMOs. Includes:
  • Maintain awareness of potential new sourcing opportunities and identify strategic sourcing partners
  • Maintainawarenessofchangingregulatorytrends in theindustrytoensureallmemberof the networkmeetorexceedcGMPsandTakedaQualityStandards
  • Provideday-to-dayoversightofCDMOstoensureoperationsremainincompliancewithsupplierperformance, SQI andprocesscapabilitymetrics. Establishkeymetricstomeasuresupplierperformance andreviewon aegularbasis
  • Provide support and oversight (if necessary) for product transfers, new product introductions and resolution of manufacturing issues
  • Responsible for both internal and external visibility to Contract Manufacturer(s) performance
  • Responsible for aligned and responsible communication of issue, including executive communication where required, through the designated communication and/or escalation channels
  • EnsureCMOalignmentwithTakedasGMSSupply ValuePropositionandannualobjectives
  • Developstrongrelationshipswith theCDMOstoenabletransparentcommunicationand strongpartnershipsbetweenthe teams
  • Lead meeting preparation and execution activities for Joint Steering Committee meetings, Business Review Meetings and internal Operation Review Meetings (CDMO dependent)
  • ResponsibletoperformannualHealthAssessment/ Voice ofCustomersurveys(internalandexternal) to monitorhealthof the teamrelationships. Createactionplanandremediatechallengesasnecessary
  • 12+ years pharmaceutical/biotechnology experience in at least two of the following cross-functional areas: manufacturing, supply chain, engineering, product development, project management, quality or procurement
  • 5+years experiencerelated to internationaloperations and/orsupply chain
  • Strong understanding of cGMP
  • Solid background in production, supply chain and regulatory requirements.
  • Experience in utility of outsourced goods and service providers
  • Held a position in which the ability to influence senior executives was demonstrated, as well as sound creative skills to utilize both traditionaland innovative solutions
  • Must have thorough knowledge of all aspects of product commercialization includingproduct development, manufacturing,project management, supply chain management, operations, outsourcing and post commercialization technical support
  • Must have experience managing teams for high performance. Must be able to present ideas with clarity, conviction and confidence. Must have a strong network among industry outsourcing/technical/business leaders.
  • Experience in two or more of the following areas:engineering,operations/productionmanager ormaterialsmanager,pharmacist/scientist.
  • Knowledge comprehensive understanding of the pharmaceutical industry or related processes from amanufacturing environment in a large multi-national prescription drug manufacturer or related organization
  • Communication ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner internally and externally
  • Strategic Implementation ability to implement and monitor the overall supply chain strategy through knowledge of companys operations,procurement expertise, industry knowledge and competitive analysis
  • Management leadership, project planning, status tracking, conflict resolution, building high performing teamsand partnering with other departments and across cultures
  • People Development ability to assess strengths and weaknesses of staff members and provide suggestions for improvement and opportunities to mentor staff
  • Analytical Skills ability toanalyzeawide variety of data including product data,freight, forecasted sales, historical demand, in-transit and potential stock-out figures to make daily management and production decisions
  • Supplier Relationship Management builds mutually beneficial relationships between company andthird partyvendors, fosters strong rapportwith local and global partners to maintain a highly reliable supply chain and high level of customer service
  • Takeda Operations comprehensive understanding of Takedas operations.
  • Willingnesstotraveltovariousmeetingsor clientsites,includingovernighttrips. Internationaltravelmayberequired.
  • Requires approximately 25% travel.
  • 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

Check out where you could be
working if you apply.

Job Seekers: Protect yourself against identity theft

Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.

At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: 2) file a complaint with the U.S. Federal Trade Commission: and/or 3) file a report with your local police department.

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Associated topics: clinician, drug, gs 610, health care, licensed practical nurse, medicaid, medicare, oncology, operating room, patient * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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