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Head of Pharmaceutical Sciences and Device Quality (Hybrid)

Company: Takeda
Location: Lexington
Posted on: February 12, 2024

Job Description:

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's Privacy Notice and 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

Job Title: Head of Pharmaceutical Sciences and Device Quality

Location: Lexington, MA

About the role:

  • Leads the global Pharmaceutical Sciences and Device Quality function, providing quality oversight of R&D Pharmaceutical Sciences, and ensuring compliance with regulatory requirements and Takeda expectations for the investigational medicinal products and devices across the enterprise.
  • This position is directly responsible for developing and aligning strategies that ensure products utilized in Takeda clinical studies are produced in compliance with applicable regulations and Takeda quality expectations and are dispositioned in a timely manner to meet clinical study and developmental timelines.
  • Serves as a senior strategic Clinical Good Manufacturing Practice and Device resource to Takeda. Subject matter expert role for the preparation, conduct, response, and follow-up to health authority inspections of Takeda's R&D activities.

    How you will contribute:

    • Leads the Pharmaceutical Sciences and Device Quality function in the development, implementation, and refinement of processes to ensure that Takeda maintains oversight of the quality of its clinical trial materials and enterprise-wide devices in compliance with applicable regulatory requirements.
    • Serves in a consultative role for compliance-related matters and supports R&D in implementing corrective and preventive actions (CAPAs). Develops strategic, pragmatic initiatives to promote compliance.
    • Sets the strategy and leads the development and execution of the master audit schedule for Contract Manufacturing Organizations (CMOs), working collaboratively with stakeholders to ensure that the audit program is robust. Ensures that appropriate CAPAs are implemented in a timely manner. Identifies potential systemic gaps and coordinates with the appropriate stakeholders to ensure a timely resolution. Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management. Analyzes results to identify actionable trends and to promote a state of compliance. Represents Takeda as a clinical GMP and device subject matter expert during health authority inspections. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda's good standing with regulatory agencies. Ensures that all inspection commitments are fulfilled on time.
    • Identifies and mitigates quality and compliance issues with potential significant impact, and ensure that lessons learned are applied across the network.
    • Maintains active interface with global Quality partners to ensure effective and efficient quality pro- grams to progress development products into commercialization.
    • Determines acceptability of CMOs for potential and/or ongoing use by Takeda, and provides on- going direction, guidance, and strategy for supplier oversight.
    • This position has overall responsibility for the ongoing development and operational success of the Pharmaceutical Sciences and Device Quality, including talent development and succession planning, resourcing, and budgeting, and alignment of Pharmaceutical Sciences and Device Quality initiatives with R&D Quality and Global Quality.
    • Leads talent management for Pharmaceutical Sciences and Device Quality employees across the globe, in partnership with the R&D Quality Leadership Team and Human Resources Business Partners. Engage in projects to ensure people development across the network
    • Serves as a member of the R&D Quality Leadership team, giving input to key strategic, portfolio, human resource and financial decisions.
    • Serves as a strategic thought partner to the Head of R&D Quality with regard to complex problems affecting development activities, with an eye to current and future initiatives, strategies, and budgets.
    • Ensure strong alignment with R&D Clinical Quality Assurance for the oversight of clinical trials.

      What you bring to Takeda:

      • BS/BA degree and advanced degree preferred.
      • Advanced knowledge of clinical Good Manufacturing Practices.
      • Minimum of 15 years of industry experience in Quality Assurance, Device and/or clinical trial materials with the majority in drug research, development, biotechnology, device, or related areas.
      • Quality Assurance professional certification/registration preferred.

        Technical/Functional (Line) Expertise
        • Expert knowledge of Good Manufacturing Practice requirements for clinical trials.
        • Advanced experience in auditing CMOs.
        • Good working knowledge of device requirements.
        • Proficient in analyzing data to identify performance trends.
        • Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues. Proven ability to proactively identify and lead the development and re-engineering of key processes and systems in support of the business's mission.

          • Highly effective communicator who is capable of establishing a compelling vision for Pharmaceutical Sciences and Device Quality.
          • Sets strategy for Pharmaceutical Sciences and Device Quality in alignment with the priorities of the Takeda Research and in alignment with the Head, R&D Quality.
          • Outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view.
          • Clear, concise, and consistent in written and verbal communications.
          • Ensures that every employee knows what is expected of their role and what it takes to be successful, and how they are progressing. Holds employees accountable to achieve results while demonstrating Takeda's values and strategic priorities of Patient, Trust, Reputation, and Business.
          • Helps employees grow through challenging opportunities so that they may realize their full potential.
          • Serves as a role model for being brave and taking appropriate risks, always in compliance with applicable regulations and Takeda requirements.

            Decision-making and Autonomy
            • Manages within the department budget established for Pharmaceutical Sciences and Device Quality, and empowered to make hiring decisions within allotted headcount.
            • Makes organizational design decisions in alignment with the Head of R&D Quality.

              • Experience working within complex organizations, working closely with senior staff and executive level colleagues. The ideal candidate will have the acumen to handle complex situations and multiple responsibilities simultaneously mixing long term projects with the urgency of immediate demands on the operations. S/he must also have the demonstrated ability to deal with highly confidential information and act as a liaison between Head of R&D Quality and other executives.
              • Demonstrated ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization.

                • Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal/regulatory documents.
                • Effectively presents information to senior management, internal groups, external stakeholders and customers.

                  • Leads Research quality oversight for the entire R&D pipeline around the globe, requiring effective cross-cultural working skills and expert knowledge of GLP requirements across health authorities.

                    What Takeda can offer you:

                    • Comprehensive Healthcare: Medical, Dental, and Vision
                    • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
                    • 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 and company match of charitable contributions
                    • Family Planning Support
                    • Professional training and development opportunities
                    • Tuition reimbursement

                      Important Considerations

                      At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
                      • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
                      • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
                      • Work in a cold, wet environment.
                      • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
                      • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

                        More about us:

                        At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

                        Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

                        This posting excludes Colorado applicants.

                        #GMSGQ #ZR1 #LI-MA1

                        EEO Statement

                        Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.


                        Lexington, MA

                        Boston, MA

                        Worker Type


                        Worker Sub-Type


                        Time Type

                        Full time

Keywords: Takeda, Boston , Head of Pharmaceutical Sciences and Device Quality (Hybrid), Healthcare , Lexington, Massachusetts

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