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Job Description

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Director Clinical Compound Support Quality Assurance

Job Location: Deerfield, IL

OBJECTIVES:



  • Provides leadership to the TGRD Clinical Compound Support QA function, and plays a leadership role in ensuring that investigator, vendor, facility and system audits are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented.
  • Serves as a senior strategic GCP/PV quality resource to TGRD for its drug development activities, and takes a lead role for the preparation, conduct, and responses to regulatory agency (e.g. FDA) audits of TGRD’s Clinical Research effort.
  • This position provides regional leadership and strategy in line with global strategic objectives. Collaborates with PDD Global Clinical Compound Support QA and with all TGRD functional areas to ensure global clinical trial activities sponsored by TGRD (US) are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda Policies and Procedures.
  • Provides strategic direction and oversight to the Pharmacovigilance QA function.


ACCOUNTABILITIES:


  • Provides direction to the US Clinical Compound Support Quality Assurance function to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance to applicable regulations.
  • Dotted line reporting relationship to PDD Global Clinical Compound Support QA. Responsible for collaborating with PDD Global Clinical Compound Support QA to develop and implement a strategic audit plan for the development of all TGRD US compounds,
  • Analyze audit program results, quality issues and investigations in order to optimize regional operations and overall regional state of compliance. Ensure that activities are conducted and reports written according to applicable SOPs and regulations.
  • Represents TGRD and may serve as Inspection Administrator during regulatory inspections. Provides strategic organizational direction to assure that responses are timely and appropriate to maintain TGRD’s (US) good standing with regulatory agencies.
  • Oversees all US GCP QA, PVQA, and GLP QA activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity.
  • Works in collaboration with PDD Global Compound Compliance and PDD Quality Systems to to identify and mitigate GCP/PV/GLP quality and compliance issues with potential impact across multiple compounds, sites, or functional groups within or outside of TGRD including TGRD EU, TGRD Asia, and JDC (Japan Development Center).
  • Collaborates with the PDD Global Compound Compliance, PDD Quality Systems, and other global Takeda entities to provide a consistent quality approach, including:


    • Develops and presents periodic reports describing TGRD compliance trends and identifying areas of potential risk to TGRD senior management.
    • Ensures that US GCP//PV/GLP QA audit strategy is harmonized with other PDD regions..
    • Identify processes and procedures to incorporate Quality Control assessments at the TGRD functional group level.
    • Develops and maintains curriculum and standards for GCP Auditor qualification.

  • Determines acceptability of vendors for potential use by TGRD US and provides direction, guidance and strategy for TGRD Quality.
  • This position has overall responsibility for the ongoing development and operational success of the Clinical Compound Support Quality Assurance (CCSQA) function. This includes talent development and succession planning, resourcing and budgeting, and alignment of CCSQA initiatives, goals and activities with PDD, TGRD and TPC goals.
Qualifications
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:


Education:


  • B.S. in Biology, Nursing, Pharmacy, or related scientific field. MS preferred.


Experience:


  • Minimum of 10 years of increasing responsibility in pharmaceutical, GCP-related Quality environment.
  • Minimum 7 years direct and indirect management level experience in GCP Quality Assurance including senior level project planning/budget management.


Knowledge and Skills:


In-depth knowledge of the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidances and Computer System Validation



  • Auditing Knowledge: Demonstrates 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 safety and data integrity.
  • Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
  • Product Knowledge: Understands the medical/therapeutic impact of products.
  • Science Knowledge: Possess the necessary science education and knowledge to manage related clinical trials and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states.
  • Communication skills: Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents. Must also be able to demonstrate professional presentation skills deliver fair balanced presentations and, when applicable, facilitate resolution of differing opinions.
  • Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution.
  • Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
  • Organizational skills: Must be able to prioritize work effectively to meet timelines.
  • Interpersonal: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
  • Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.


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:


  • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Requires approximately 25% travel.



We are driven to improve people's lives.




We are an equal opportunity employer.

No Phone Calls or Recruiters Please.

Schedule
Regular Full-time

Job ID: 1100659
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About Research and Development

Takeda is a research-based pharmaceutical company dedicated to delivering innovative medicines to patients. Our current focus is on the research and development of new treatments for metabolic diseases, cardiovascular disease, central nervous system disorders, chronic kidney disease, gastroenterology, oncology, and other diseases. In the United States, Takeda has drug discovery sites in California (Takeda San Diego and Takeda San Francisco), as well as a development center in Illinois (Takeda Global Research & Development). We have excellent career opportunities including Medical Directors, Clinical Scientists, Research Scientists, Medical Writers, Pharmaceutical Scientists, Statisticians, Project Managers, Quality Assurance jobs and more. Read on and discover your place at Takeda.

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Location Info

Deerfield, IL
USA
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