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Associate Director/Director Clinical Quality Assurance

Cambridge, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

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!

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Success

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

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Values-Led

    Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • People-First

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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Associate Director/Director Clinical Quality Assurance

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Job ID R0006591 Date posted 01/18/2019 Location Cambridge, Massachusetts

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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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