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Quality Control Associate Director, External Biologics

Lexington, Massachusetts


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Quality Control Associate Director, External Biologics

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Job ID R0032466 Date posted 05/13/2021 Location Lexington, Massachusetts

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Quality Control Associate Director, External Biologics in our Lexington, MA office.

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

In this role, you will contribute to Takeda’s mission by having the ability to lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy. As a Quality Control Associate Director on the External Biologics Quality Control & Microbiology team, you will:

  • Provide QC oversight and effective management of Takeda’s contract test laboratory (CTL) organizations for Drug Substance and Drug Product release and stability testing.
  • Initiate, manage and improve quality aspects of CTL relationships to enable supply of Takeda products to our patients which meet both the Takeda and Health Authorities GMP standards.
  • Provide interpretation of data trends for both release and stability, life cycle of methods and other technical support as required.
  • Lead investigations with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making.
  • Lead external critical reagents and reference standard management and coordination of shipping of reagent activities.
  • Responsible for Quality control & Microbiology related KPIs and continuous improvement.
  • Work closely with colleagues in external supply, technical services, planning, regulatory and other functions as required to meet the needs of patients and the business.
  • Mentor team members and colleagues to resolve complex problems; Support strategy and plans for the Quality Control Quality organization to meet the Quality Control, External Biologics Quality and OpU vision and where appropriate, support development and management of the finances expended by the team


  • This position is responsible for oversight of CMO’s / CTL’s within Technical Operations according to Takeda, GMP & GDP standards. This role leads a team to ensure that Shire’s CMO’s /CTL’s are working to the expectation of Takeda and the required regulations.
  • Leads and executes goals for the function that helps drive strategy execution to enhance and maintain Takeda CMO/ CTL QC oversight in compliance with Takeda global standards. Is responsible for finding solutions to effectively navigate and correct misalignment between different stakeholders both within and outside the operating unit.
  • Builds and maintains strong relationships with key internal and external partner organizations and will be expected to develop and deliver shared objectives with key partner groups.
  • Accountable for delivering on CMO/CTL Quality goals and key performance indicators
  • Lead timely resolution of critical issues by developing solutions to complex problems.
  • Analysis of CTL management processes, partners with operational excellence in the development of quality improvement plans and continuous improvement.
  • Responsible to work with the compliance lead to ensure CTL’s are inspection ready.
  • Responsible to support any technical transfers / projects/ validation/ launch activities related to CMO’s/ CTL’s as required
  • Support internal and regulatory agency inspections at Takeda
  • Support testing, executing method transfer projects and lab audits
  • Supporting the establishment and revision of product specifications
  • Expeditiously and objectively investigating laboratory exceptions and supporting manufacturing investigations
  • Timely trending of data and operational key performance indicators
  • Identifying and/or remediating technical, compliance, and efficiency gaps
  • Authoring/reviewing regulatory submissions
  • Establishing/improving technology solutions to support people and processes
  • Providing accurate and timely updates of group activities to Quality Control management with a focus on compliance, cycle times, cost management, and productivity

Education, Behavioral Competencies and Skills

  • Ph.D. in Biology, Chemistry, or other related fields with >6 years of relevant experience, MS. with >10 years of relevant experience or BS with >12 years of relevant experience.
  • Experience in CMO/CTL oversight
  • Thorough understanding of quality systems, global Health Authorities requirements in the GMP and GDP regulated area
  • Recognize the importance of meeting patient, compliance and business needs
  • Experience in a multinational organization effectively navigating differing regional expectations and regulations
  • Experience leading, training and/or implementing root cause analysis and effective investigation practices
  • High level of professional competence. Preferably demonstrated by objective certification.
  • Experience in interacting with health authorities including hosting/direct involvement with agency inspections.
  • Strong verbal and written communication (including presentation) and customer management skills
  • Demonstrated project management and process improvement experience.

Skills required:

  • Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
  • Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
  • Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
  • Regulatory Understanding – broad based knowledge of domestic and international regulations associated with manufacturing, testing and packaging
  • Fluent in written and spoken English
  • Excellent intercultural communication, negotiation, and practical problem-solving skills.
  • Cross functional and matrix management. Preferred experience in large, multi-national, matrixed organizations.
  • Experience with lean processes

Additional Information
Some business travel is required, including international travel 30%

What Takeda Can Offer You

  • Excellent conditions & benefits including generous holidays
  • Genuine career progression and development
  • Opportunity to work with a world class leader in the pharmaceutical sector
  • 401(k) with company match and Annual Retirement Contribution Plan
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Community Outreach Programs

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.

Empowering Our People to Shine

This job posting excludes CO applicants.


Lexington, MA

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0032466
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