Posted to MedZilla on 9/18/2019


Takeda Pharmaceuticals

US-MA, Incident Management Lead, US SR0039753-MZ


 
 

OBJECTIVES/PURPOSE

  • Management of quality incidents to remediate risk
  • Ensure QAM and MAC forums occur in a timely manner with all required detail to facilitate decision making
  • Ensure appropriate, timely consistent decision making during the management of Quality Incidents
  • Ensure compliance with regulatory reporting requirements
  • Implementation of CAPA actions to remediate defect issues
  • Ensure required recall actions are capable of removing the maximum percentage of impacted product from the market

ACCOUNTABILITIES
Primarily responsible for managing the Global Incident Escalation Process and associated outputs.

  • Owns Quality Incident record from beginning to end
  • Assists sites / incident owners with information gathering and preliminary assessments
  • Reviews incoming incident forms for accuracy and content
  • Reviews and approves QAM and MAC slide decks
  • Oversees QAM and MAC meetings and coordinates actions
  • Assists with decision making before, during and after an incident is escalated and liaises with relevant functions to ensure that the incident is logged, actioned and closed within the required timelines.
  • Coordinates all actions coming out of the escalation meeting, including review and submission of regulatory notifications FAR, BPDRs, PDRs, Type C Meetings etc.
  • Acts as global lead for any Field Corrective Action resulting from the incident
  • Liaison with Investigations team to monitor implementation of CAPAs and other actions
  • Monitors performance of the Incident Escalation Process via periodic report-outs
  • Assists with compilation of APQRs and Quality Councils and provides data to audit teams

Responsible for global coordination of Field Corrective Actions, including recalls, DHPCs and market corrections.

  • Establishes FCA team and and ensures that FCA actions are carried out according to procedures.
  • Monitors effectiveness of recall and other actions and measures effectiveness via actual and mock recalls.

Responsible for Quality Management and Continuous Improvement of QIM process

  • Business Process Management of QIM , FCA, Defect Reporting, Product Hold and Drug Shortage Notification SOPs. Responsible for ensuring and monitoring business process effectiveness
  • Responsible for driving continuous improvement, through weekly team meetings, BPM effectiveness, Blue-belt projects and ad hoc CI initiatives

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS

  • Bachelor s degree in a relevant scientific/engineering discipline with at least 5 to 7 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing related experience.
  • Working knowledge of Regulations, US and EU Regulations, including GMPs and GDPs

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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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.