Complaints Lead ROW

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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 Complaints Lead ROW.

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.

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:

• Lead a team of complaint specialists/managers in the management of complaints

• Serve aspoint of contact for commercial and clinical product complaints and post market product vigilant monitoring processes

• Receive, process, initiate and approve product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and 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 multiple departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance and the regional organization. Work with external team members 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.

What you bring to Takeda:

• Bachelor's degree with a minimum of 12 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 experience in managing team members to achieve high performance, while supporting their professional development and growth

• 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.

What Takeda can offer you:

• Competitive salary and performance-based bonus

• Employer retirement plan contributions

• Employee Stock Purchase Plan

• Revenue approved profit share scheme

• Employer funded income protection

• Employer funded private medical insurance with dependants’ cover

• Employer life insurance contributions

• Electric charging points available at parking locations

• Employee Assistance Program

• Wellbeing and engagement teams

• Takeda Resource Groups

• Flexible working arrangements, e.g., hybrid or shiftwork with shift allowance

• Family friendly policies

• 26 vacation days plus additional days for service milestones

• Coaching and mentoring

• Educational programs and formal training

• Development opportunities

• Humanitarian volunteering leave options

• On-Site Gym

• Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals

More about us:

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.

Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change, and innovation. Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years.

How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.

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