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Small Molecule & Oncology Complaints Lead, Associate Director

Dublin, Ireland


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Small Molecule & Oncology Complaints Lead, Associate Director

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Job ID SR0039041 Date posted 09/09/2019 Location Dublin, Ireland

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Small Molecule & Oncology Complaint Lead, Associate Director.

As our successful Small Molecule & Oncology Complaints Lead, Associate Director, you will be responsible for leading and managing the product complaints team and all related activities associated with the complaint handling program at Takeda per corporate procedure and regulatory standards, including goal setting in-line with corporate strategy and priorities and the GQ road map.

The scope of your responsibility will encompasse timely management of the complaint processes to comply with corporate procedures, EU and FDA regulations, ISO13485 and other regulatory requirements as applicable.

You will escalate and participate in resolution of potential product deficiencies for all applicable Takeda products originating from a market complaint.

You will liaise with internal stakeholders, Call Centres and service providers to ensure they support Takeda’s corporate policies and guidance while aligning with all the necessary regulations and standards.

You will serve as our 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.

Key Accountabilities

  • Leading a team of complaint specialists/managers in the management of complaints
  • Serve as point of contact for commercial & clinical product complaints and post market product vigilant monitoring processes
  • Receive, process, and initiate 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 Centres and vendors/contractors on product complaint issues.
  • Assure that all product complaints are investigated to the appropriate level within the required timeline.
  • Critically review and approve all investigations
  • Represent Takeda as the Subject Matter Expert (SME) for the product complaints process during Internal, External and Regulatory Body Inspections.
  • Drive continuous Improvement
  • Accountable and an empowered leader for all operational decisions relating to complaint management with sound and timely decision-making using available information and based on the complexity and impact of decisions, will consult or inform relevant stakeholders and escalate if necessary.
  • Interacts with senior Quality, GMS leadership, cross functional teams as well all external parties relevant to complaint management. Acts as primary liaison with regulatory agencies in terms of quality complaint management.
  • Builds strong collaborative working relations across the OpUs and regions.

Education, Behavioural Competencies  

  • Bachelor's degree with a minimum of 12 years of experience in Quality Assurance or a GMP related related field within Medical device, biotechnology or pharmaceutical manufacturing.
  • Must be QP Qualified and ideally named on a manufacturing licence releasing SM products.
  • 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.
  • Skill in writing investigation summaries and complaint responses.
  • 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.
  • Experience in managing teams at a site level and globally.
  • Subject Matter Expertise in assigned product platform (Small Molecule) and a strong working knowledge of the complaints process or multiple pharmaceutical quality management systems. 

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.

Job ID SR0039041

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