Senior Quality Complaints Specialist

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a Senior Quality Complaints Specialist.

You will be responsible for writing, investigating and approving product quality complaints 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.

Takeda's presence in Ireland was established in 1997 and our Irish operations have played a key role in our global leadership in rare diseases, oncology and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology.

This is a hybrid role located in our Baggot Street office, and you will report to the Head of Market Surveillance.

How you will contribute:

• Initiate, write, approve and manage the complaint investigation to completion.

• Be the point of contact for commercial product complaints and post market product vigilant monitoring processes.

• Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management mailbox and software.

• Coordinate all aspects of investigation through to 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.

• Work and collaborate with several departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organisation. Interface with external partners 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. Send customer response letters where required.

• Support the departmental complaint management process through attendance of meetings to ensure on time closure of complaints.

• Support line manager to meet business needs.

What you bring to Takeda:

• 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, or equivalent.

• 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.

• Experience with the manufacture of combination products and the linkage to customer complaints.

• Skill in writing investigation summaries or reports and complaint responses.

What Takeda can offer you:

• Competitive salary and performance-based bonus