Posted to MedZilla on 9/22/2019


Takeda Pharmaceuticals

US-MA, Director QI Investigation Management SR0039468-MZ


 
 

OBJECTIVES

  • Accountable for leading significant site/regional investigations, driving to determine root cause, product impact, CAPA and timely investigation closure.
  • Supporting the development of increased investigation capabilities across sites/regions network
  • Accountable for determination of product impact for significant events and triggering the incident escalation process in a timely manner when required.

SCOPE

  • Ensures effective investigation management for significant Quality Incidents which will potentially trigger the Takeda incident management process
  • Interacts with a broad range of internal stakeholders to ensure complex events/investigation are efficiently managed, escalated if required and progressed to closure in a timely manner
  • Develops and rolls out investigation training to build sustainable investigation capabilities across the Takeda site/regions

ACCOUNTABILITIES

  • Accountable for driving significant site/regional investigation to root cause, determination of product impact, scope definition, can CAPA effectiveness
  • Accountable for developing and delivering a comprehensive training program to build sustainable cross-functional investigation capabilities across sites/regions
  • Accountable for timely triggering of the incident escalation process for significant investigations which have potential product quality/patient safety impact.
  • Accountable for representing the Takeda investigation process during site regulatory inspection.
  • Responsible for leading/support site remediation where significant compliance deficiencies are identified.
  • Responsible for the execution of site complaint investigation in a timely manner (as needed).

Technical/Functional (Line) Expertise

  • Knowledge and understanding of Biologics, Plasma and Small Molecule manufacturing therapeutic areas as well as scientific advances and modalities for treating diseases.
  • Deep knowledge and understanding of international health authorities compliance requirements

Leadership

  • Ability to lead significant investigations related to Quality Incidents, drive to root cause, product impact, CAPA and timely investigation closure.
  • Ability to lead and engage in complex investigations and propose sound, scientific and compliant resolutions and ensure escalation to the incident management process as required
  • Ability to support increased organizational investigational capability across sites, regions and OpUs as required.

Decision-making and Autonomy

  • A member of the PQ&IM team contributing to the execution of strategic plans for the function and development of annual goals
  • Responsible for supporting the increased investigation capabilities across sites/regions and OpUs.

Interaction

  • Key interactions across all manufacturing and Quality regional and operating unit teams
  • Key interactions with Supply & Business Excellence to support increased investigation capabilities across the sites/regions/OpU
  • Key Interactions with the OpU and Region Compliance Leads
  • Key interactions with the incident management team to ensure timely escalation of significant events/incident and regulatory reporting if required

Innovation

  • A firm grasp of industry, scientific and regulatory trends, understands market conditions and leverages innovation to evolve Takeda s profile to become the model for the industry

Complexity

  • This is a global role with significant impact on Takeda s ability to investigate significant and complex manufacturing events and to facilitate timely escalation and decision making. The output from this role and the associated team is applied across the Takeda product portfolio.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Education / experience

  • Scientific degree (BSc, MSc)
  • 10+ years of experience in the pharmaceutical industry working within the Quality organization
  • Experience working in an international environment
  • Knowledge and experience of BioPharmaceutical Manufacturing and the management of complex investigations
  • Deep knowledge and understanding of international health authorities compliance requirements
  • Fluent in written and spoken English

Core Competencies / Skills

  • Critical Thinking
  • Current on local and global regulations
  • Digital and analytical skills
  • Problem-solving, fishbone, DMAIC
  • Strong communication skills engaging stakeholders: site, business, network, company, regulators
  • Risk identification, evaluation and management
  • Continuous improvement

Leadership Behaviors

  • Strategic enterprise thinking, finding innovative ways to serve patients, build reputation and trust
  • Creating an environment that inspires and enables people
  • Focusing on the few priorities and provide superior results
  • Elevating site/regional/OpU investigation capabilities for now and the future

Travel up to 25% (national and international)

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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