Posted to MedZilla on 10/13/2019


Takeda Pharmaceuticals

US-MA, Head, Good Pharmacovigilance Practices Quality Operations R0011910-MZ


 
 

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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 a Head, GVP Quality Operations in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director working on the Global Patient Safety Evaluation Quality Assurance team, you will be empowered to support global functions o in the implementation of Takeda Quality Management System (QMS) methodology, infrastructure and tools, and a typical day will include:

OBJECTIVES:

  • This role supports the global functions of GPSE, GMA and GRA (excluding CMC)
  • Define and implement strategies for maintaining compliance within stakeholder group; proactively engaging with stakeholders to build in and ensure compliance with GVPs
  • Provides risk-based rationale to enable decision-making, serves as the subject matter expert for integration of quality data and supports the development and execution of effective and comprehensive action plans to address quality and compliance risks.
  • Reports to the Head of GPSE QA and serve as a member of the GPSE QA Leadership Team (GPSE QA LT).

EDUCATION, EXPERIENCE AND SKILLS:

Education & Experience

  • Bachelor s Degree required; Advanced Degree preferred.
  • Minimum 12 years of increasing responsibility in pharmaceutical, GCP- and/or GVP related Quality environment.
  • Minimum 10 years of people and/or process management experience in GCP and/or GVP Quality Assurance including senior level project planning/budget management.
  • Minimum 8 years of progressive matrix management experience, and extensive experience leading a team dispersed in multiple, global locations.
  • Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives
  • Skilled in managing global, cross-functional projects

Skills/Knowledge:

  • Regulatory Knowledge - Expert knowledge of global GCP and GVP regulations and guidances; good working knowledge of global GMP and GLP regulations and guidances. Understands the regulatory environment for global pharmaceutical companies, as well as best practices in the Pharma industry to satisfy regulatory requirements.
  • Industry Knowledge Strong working knowledge of the pharmaceutical industry and the new drug development process; understands the phases, processes and techniques used to execute a clinical development program.
  • Demonstrates advanced knowledge in the conduct and reporting of audits and investigations, as well as the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
  • In-depth understanding of the good practices for the creation and management of a Quality Management System.
  • Scientific Knowledge - Possesses the necessary science education and knowledge to provide Quality Assurance oversight of 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, both verbally and in writing. Must demonstrate professional presentation skills.
  • Negotiation Skills - Demonstrates proficiency in negotiation and conflict resolution.
  • Personnel Management Knowledge Proficient in managing large teams, and in providing coaching and mentoring to employees.
  • Project Management - Demonstrates 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, and delegate to subordinates.
  • 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 or equivalent preferred.
  • Six Sigma Green Belt or Black Belt preferred.

PHYSICAL DEMANDS:

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

TRAVEL REQUIREMENTS:

  • Position is located in Boston.
  • Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel will be required.
  • Requires approximately 25 % travel.

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.

#LI-LC1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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