Posted to MedZilla on 9/16/2019


Takeda Pharmaceuticals

US-MA, Small Molecule & Oncology Complaints Professional SR0039043-MZ


 
 

OBJECTIVES/PURPOSE

Responsible for writing, investigating and managing the product complaints related to Oncology and Small Molecule and all related activities associated with the complaint handling program at Takeda per corporate procedure and regulatory standards.

The scope of responsibility encompasses timely management of the complaint processes to comply with corporate procedures, EU and FDA regulations, ISO13485 and other regulatory requirements as applicable. Escalate and participate in resolution of potential product deficiencies for all applicable Takeda products originating from a market complaint. Liaise with Internal Stakeholders, Call Centers and service providers to ensure they support Takeda's corporate policies and guidance while aligning with all of the necessary regulations and standards. Serve as the Quality liaison between individuals and business units within or outside the organization regarding matters related to product complaint activities, including risk management, regulatory inspections and complaint handling processes for all applicable products.

ACCOUNTABILITIES

  • Initiating, writing and managing the complaint investigation to completion.
  • Serve as point of contact for commercial & clinical product complaints and post market product vigilant monitoring processes
  • Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and/or provide oversight for complaint handling process.
  • Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
  • Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
  • Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organisation. Interface with external stakeholders such as CMO, Call Centers and vendors/contractors on product complaint issues.
  • Assure that all product complaints are investigated to the appropriate level within the required timeline.
  • Represent Takeda as the Subject Matter Expert (SME) for the product complaints process during Internal, External and Regulatory Body Inspections.
  • Drive continuous Improvement

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Minimum of a Bachelor's degree with a minimum of 5 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing.
  • Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
  • Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
  • Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
  • Good understanding of the manufacture of combination products and the linkage to customer complaints.
  • Strong attention to detail, good organizational skills and well-structured.
  • Has a systematic way of working, prioritizing tasks based on risk or criticality - seeking effective solutions within the complexity that surrounds product complaints.
  • Excellent troubleshooting and problem-solving skills.
  • Skill in writing investigation summaries and complaint responses.
  • Independent, organized and able to schedule work without supervision to meet schedule deadlines.
  • Ability to work independently as well be an effective team member and leader.
  • Approachable and possess the ability to forge solid working relationships with colleagues across all functions, its partners and contractors.

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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