Posted to MedZilla on 10/14/2019


Takeda Pharmaceuticals

US-MA, Head, Good Pharmacovigilance Practices Inspection Readiness R0011909-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 Inspection Readiness 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 lead inspection readiness activities, enabling proactive inspection readiness across the entire PV System and support inspections where GSPE is a stakeholder, and a typical day will include:

OBJECTIVE:

  • Drives the inspection strategy for the PV System, using the framework provided by R&D Quality Compliance and Systems and assures inspection planning across PV System enabling ongoing efforts to maintain a steady state of inspection readiness. Engages senior leadership to enable execution of the plan.
  • Identifies risks within the PV System and drives mitigation/remediation activities.
  • Develop strategy for hosting on site business partner audits, leveraging experiences to improve on inspection readiness activities.
  • Clear understanding of Takeda s inspection risk
  • Reports to the Head of GPSE QA and serve as a member of the GPSE QA Leadership Team (GPSE QA LT).

ACCOUNTABILITIES:

  • Provides leadership for the GPSE QA Inspection readiness organization, cascading messages and goals from senior management, managing & prioritizing team workload, managing team performance
  • Lead inspection response activities ensuring a Quality Contact is assigned for CAPAs owned by stakeholders
  • Develop strategy to understand health of the PV System, e.g. risk register, KPIs
  • Partner with R&D Quality Compliance and Systems and stakeholders for internal audits related to PV System
  • Host audits conducted on site from business partners
  • Take a leadership role during inspections to organize site departments, coach subject matter experts, or interface with inspectors.

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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