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 Professional 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.
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
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 root cause and defines and implements corrective or preventive actions
Works closely with OncESSM Quality OpU leadership to support the forecast of future spend, 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.
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.
Support Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and help drive to closure.
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.
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).
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Bachelor's Degree in Engineering, Business, Chemistry, Biology, or related discipline.
5+ years experience in in the pharmaceutical industry and/or QA/QC laboratory environment.
Must have good understanding of a variety of analytical techniques such as HPLC, dissolution, GC, CE-SDS, bioassay and icIEF.
Experience in cell based assays and oral solid dosage is a plus.
Experience in analytical laboratory, method execution, qualification and/or validation of small molecule or biologics assays.
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).
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 trust of leadership and leverage relationships to provide best possible financial plans.
Fluent in written and spoken English
Core Competencies / Skills
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
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 the 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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Takeda Pharmaceutical Company Ltd