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Manager Quality Control, Small Molecule-GMS

Lexington, Massachusetts

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Manager Quality Control, Small Molecule-GMS

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Job ID R0024025 Date posted 04/12/2021 Location Lexington, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Control Senior Manager 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.

POSITION OBJECTIVES:

  • This position has responsibility for operational, technical and compliance oversight for Global Oncology External Supply Small Molecule (OncESSM) Quality Operating Unit (OpU) Quality Control (QC) release and stability testing performed at external service provider (contract test labs and manufacturing organizations; CTLs and CMOs) for small molecule, recombinant biologics and cell therapy products as part of the global QC function
  • Create, maintain analytical documentation, e.g. protocols, reports, specifications, methods, etc.
  • Directly liaises with, and manages, relationships with external testing partners to ensure continuity of testing, investigation, and resolution of unexpected results and represents Takeda in interactions with providers
  • Develops, compiles, and monitors performance metrics and drives continuous improvement of activities within QC organization
  • Lead or support analytical and manufacturing investigations of unexpected results to identify the root cause and defines and implements corrective or preventive actions
  • Works closely with OncESSM Quality OpU leadership to support the forecast of future spending, monitoring variances, and drive improvements with financial benefit.
  • Provides support to data analysis, data entry, purchase order creation/reconciliation and financial oversight of third-party labs in the US and other regions as required by the third-party lab locations.
  • Supports compliance of testing network through participation in external provider audits, data review and data integrity verification, development of quality agreements and assures execution to requirements.
  • Support regulatory filing and product APQR.

POSITION ACCOUNTABILITIES:

Primary duties of the position are focused around non-laboratory support of the QC functions. Primary activities would generally include but not limited to data analysis, data trending, project and testing coordination, product and material specification management, inspection support, investigation leads, operational excellence leads, document revisions, initiating/completing quality systems, method/equipment validation and method projects activities.

  • Act as deviation/Lab investigation owners, support Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and help drive closure in a timely manner.
  • Collates and reports out third party lab performance metrics
  • Provides financial oversight of third-party labs to assure budget requirements are met and is accountable for the CTL financial processes execution (ie. PO generation, invoice processing, etc.) of the Global OncESSM Quality Control unit.
  • Work with the head of OncESSM QC, QC Business Operations Lead and QC  Strategy and Business Operations to provide input on financial estimates and assumptions.
  • Develops testing plans and support method transfers as needed
  • Manage stability study protocol development, execution, data analysis, and reporting for OpU products as designated
  • Develop explanations for financial variances that occur on a monthly basis and make recommendations.
  • Develop data summary and communication tools such as dashboards, reports, and product quality review.
  • Evaluate business processes and propose and carry through continued improvement opportunities.
  • Cultivate and maintain relationships with key internal and external customers.
  • Initiate Change Controls to support change of vendor/TPIC specification documents, vendor test methods, stability protocols, and relevant site batch records.
  • Be a valued partner by providing actionable decision support (e.g. what-if scenarios for decision making).
  • Provide technical support to other QC activities as business needs arise.
  • Maintain training records current and GMP compliance when conducting Takeda business.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelor’s Degree or post-graduate degree in Chemistry, Biology, or related scientific discipline.
    • 10 + years experience in the pharmaceutical industry and/or QA/QC laboratory environment.
    • Must have a good understanding of a variety of analytical techniques such as HPLC, dissolution, GC, FTIR, wet chemistry and other analytical techniques. Must have experience in analytical investigations, handling of OOS, OOT investigations.
    • Experience in API and oral solid dosage is a plus.
    • Experience in analytical laboratory, method execution, qualification, and/or validation of small molecule or biologics assays.
    • Experience in regulatory support, authoring dossier sections, respond to regulatory inquires.
    • Strong communication and technical writing skills.

Cross-functional and matrix management experience.
• Awareness of financial processes.
• Project management experience
• General understanding of applicable regulations and guidance.
• Strong proficiency in Microsoft tools, especially Excel.
• Knowledge of Laboratory Information Systems (LIMs).


Skills required:
• Communication – strong verbal and written communication skills with the ability to communicate ideas and data in a persuasive, organized, and appropriate manner.
• Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions.
• Teamwork – ability to establish professional relationships and rapport with internal and external peers and higher-level management.
• Proactiveness – ability to anticipate potential problems and taking the initiative to address these issues.

• Regulatory Understanding – general knowledge of regulations associated with manufacturing and packaging
• Customer Service Orientation - ability to gain the trust of leadership and leverage relationships to provide the best possible financial plans.
• Fluent in written and spoken English
Core Competencies / Skills
• Critical thinking
• Problem solving
• Digital and analytical skills
• Continuous improvement mindset
• Current on local and global regulations
• Business-oriented with a good business understanding
• Strong communication skills engaging stakeholders
Leadership Behaviors
• Enterprise thinking, finding innovative ways to serve patients build reputation and trust.
• Drive for results, meeting customer expectations, and able to influence relevant internal and external stakeholders.
• Proactive and self-motivated, with a hands-on attitude and approach.
• Excellent intercultural communication, negotiation, and influencing.
• Open-mindedness towards change, and a desire to learn.
• Focusing on a few priorities and provide superior results.
• Elevating capabilities for now and the future.

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

Empowering Our People to Shine

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This job posting excludes CO applicants.

No Phone Calls or Recruiters Please.

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Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0024025
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