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Associate Director/Director Clinical Quality Assurance

Success Profile

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

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Engage Others Motivates and influences others to gain support for ideas, strategies and actions in service to providing superior pharmaceutical products to patients; provides appropriate background so that messages are meaningful with audiences.

Collaboration Establishes productive relationships and partners with others across the organization to ensure common understanding of objectives and achieve shared goals.

Drive for Results Holds self and others accountable for delivering on commitments that align with our short- and long-term goals, never forgetting the end result is to help patients through innovation in medicine.

Strategic Approach Makes sound decisions that are consistent with our mission, values and organizational objectives.

Lead Change Proactively evaluates, promotes, and initiates change that creates value for patients, the organization, and our shareholders.

Self Awareness Seeks feedback from others, modifies self-perceptions and actions based on this feedback, and actively develops skills and behaviors to enhance contribution.

Develop Capabilities Seeks opportunities to develop oneself and others so that we can continue to achieve sustained growth.

Rewards

  • Teamwork

    Takeda builds strong, borderless and empowered teams through fairness and promoting shared goals. By working together, we optimize energy and can lead the change for a better world.

  • Innovation

    Takeda implements bold initiatives on a daily basis by striving for continuous improvement and encouraging enthusiasm and creativity. This value speaks to attracting the best minds in the industry that are committed to delivering novel therapies to patients worldwide.

  • Diversity

    Takeda respects and includes a broad range of people and ideas in its daily operations. Our organization encourages each individual to act with empathy and to apply their unique skills to realize the company’s true potential.

  • Passion

    Takeda's drive comes from perseverance, urgency and a strong desire to contribute to patients. We put this passion to work in everything we do and demonstrate courage to fight for ideas and objectives to raise the quality of our solutions, create stronger ties with our stakeholders, and deliver results.

  • Commitment

    Takeda works to meet its responsibilities to stakeholders on a daily basis. We provide adequate support and challenge to ensure we deliver high-quality solutions that help more people around the world.

  • Transparency

    Takeda appropriately shares information and promotes honest, sincere dialogue with stakeholders to build trust. This trust enables us to strengthen our relationships with employees and external communities.

Videos

  • Medicine for the World

  • Inspired by Patients

  • Corporate Citizenship Activities

News and Events

  • Moving Mountains

    Moving Mountains My Story and Why I’m Climbing.
    I oversee Corporate Communications at Takeda Oncology. We're committed to discovering and developing treatments for patients with cancers.

  • One Vision: We aspire to cure cancer.

    Takeda completes acquisition of ARIAD Pharmaceuticals, Inc., significantly enhancing our global oncology portfolio and reinforcing our commitment to develop medicines for patients living with cancer.

  • Our communities

    Rushing Toward a Cure (RTC) launched in 2006 in partnership with the Patriots Radio Network (WBZ 98.5) and our local chapter of the Leukemia & Lymphoma Society (LLS). With RTC, Takeda Oncology contributes a set financial donation to the LLS for every 100 rushing yards gained by New England during the pre, regular and post-seasons. This money helps fund vital blood cancer research, patient services and education programs.

Overview

Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

Our US Offices are in Cambridge, MA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.

While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

Responsibilities

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.  Join us as an Associate Director/Director Clinical Quality Assurance in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director/Director working on the R&D Quality team, you will be empowered to provide strategic leadership to the Takeda Clinical Quality Assurance Program Managers and partner with key stakeholders that are integral to clinical development activities, and a typical day will include: 

OBJECTIVES: 

  • Contribute to the design and implementation of Takeda’s risk-based GCP audit and compliance oversight activities. 
  • Monitor effectiveness of GCP processes through risk-based audits and GCP compliance activities, and provide actionable data to Senior Management based on identified compliance issues and trends.
  • Oversee and provide necessary support for the GCP components of Regulatory Inspections.

ACCOUNTABILITIES: 

Leadership & Partnership

  • Provides leadership and guidance to the Takeda Research and Development Clinical Compound Support Quality Assurance Program Managers to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required are maintained in compliance with applicable regulations, as applicable. 
  • Provides ongoing development of the Clinical Quality Assurance (CQA) Program Managers, including staff selection, work assignments, goal completion, development plan review, and performance management, as applicable. 
  • Establishes strong partnership/relationship with business stakeholders
  • Recognized as a senior strategic GCP and bioanalytical quality resource

    Design & Implementation of Audit & Compliance Monitoring Programs

  • Develops and implements a strategic audit plan in collaboration with R&D Global Compound Support Leaders.
  • Maximizes effectiveness and efficiency in the use of internal and external Compound Support resources.
  • Ensures audit observation, report, and rating consistency for assigned area of responsibility.
  • Ensures activities are conducted and reports written according to applicable SOPs and regulations.
  • Provide quality assurance leadership and influence to drug development teams.
  • Acts as a quality resource with expertise in regulations relating to GCP, ICH guidelines, and Clinical Operations SOPS.
  • Responsible for the QA due diligence for new compounds/alliances for Quality, in collaboration with senior management in QA.
  • Manage Therapeutic Area Programs of a highly complex nature and/or high risk programs including, multiple indications, data safety monitoring boards, endpoint review committees as well as those  requiring the coordination of multiple “nitch” vendors

    Interpret the GCP State of Compliance

  • Supervises and oversee the analysis of audit program results, quality issues and investigations in order to optimize regional operations and global state of compliance. 
  • Generates and interprets data for Quality Council and global compliance reports.
  • Works in collaboration with Takeda R&D Global Compound Support QA and Quality Systems QA to identify and mitigate GCP quality and compliance issues with potential systemic impact.
  • In collaboration with Supplier Quality QA, determines acceptability of vendors for potential use by Takeda R&D as well ongoing evaluation of the vendors overall compliance performance.
  • Monitors and interprets compliance issues identified across clinical programs and elevates systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution across Takeda R&D.
  • Provides appropriate risk analysis for key stakeholders to make critical decisions.

    Regulatory Inspection Support

  • Represents Takeda R&D during GCP regulatory inspections assuring management that responses are timely and appropriate to maintain good standing with regulatory agencies.
  • Coaches and educates external sites and cross functional Takeda R&D staff in regulatory inspection readiness activities. 
  • Represents CQA during regulatory inspections.  Assures that responses are timely and appropriate to maintain Takeda good standing with global regulatory agencies.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

Education:

  • Bachelor’s Degree required; Advanced Degree preferred.

Experience:

  • Minimum 8 years of experience in the pharmaceutical or biotechnology industry with 6 years of GCP QA experience
  • Minimum 5 years managing teams in a matrix team environment or managing people.

Knowledge and Skills:

  • Advanced knowledge and demonstrated experience in  the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, Global Drug Development  Regulations and Guidances and Computer System Validation
  • In-depth knowledge of drug development processes and GCP regulations
  • Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject protection and data integrity.
  • Demonstrated ability to effectively organize and execute tasks
  • Strong verbal and written communication (including presentation) and customer management skills.
  • Demonstrates proficiency in negotiation and conflict resolution.
  • Computer proficiency 

LICENSES/CERTIFICATIONS:

  • ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.   

PHYSICAL DEMANDS: 

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).   
  • Carrying, handling and reaching for objects.

TRAVEL REQUIREMENTS:

  • Takeda is a global company.  Travel is a requirement of the position.

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

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0006591

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