Join us as a QI Investigation Management Lead in our offices in either Dublin, Ireland or Zurich - Opfikon, Switzerland.

OVERVIEW

The QI Investigation Management Lead is accountable for leading significant site/regional investigations, driving to determine root cause, product impact, CAPA and timely investigation closure.The QI Investigation Management Lead supports the development of increased investigation capabilities across sites/regions network.The QI Investigation Management Lead is accountable for determination of product impact for significant events and triggering the incident escalation process in a timely manner when required:The QI Investigation Management Lead ensures effective investigation management for significant Quality Incidents which will potentially trigger the Takeda incident management process.The QI Investigation Management Lead interacts with a broad range of internal stakeholders to ensure complex events/investigation are efficiently managed, escalated if required and progressed to closure in a timely manner.The QI Investigation Management Lead develops and rolls out investigation training to build sustainable investigation capabilities across the Takeda site/regions.

ACCOUNTABILITIES

The key accountabilities of the QI Investigation Management Lead include, but are not limited to:

Accountable for driving significant site/regional investigation to root cause, determination of product impact, scope definition, can CAPA effectiveness.Accountable for developing and delivering a comprehensive training program to build sustainable cross functional investigation capabilities across sites/regions.Accountable for timely triggering of the incident escalation process for significant investigations which have potential product quality/patient safety impact.Accountable for representing the Takeda investigation process during site regulatory inspection.  Responsible for leading/support site remediation where significant compliance deficiencies are identified.Responsible for the execution of site complaint investigation in a timely manner (as needed).

DIMENSIONS & ASPECTS

Technical/Functional (Line) Expertise

Knowledge and understanding of Biologics, Plasma and Small Molecule manufacturing therapeutic areas as well as scientific advances and modalities for treating diseases.Deep knowledge and understanding of international heath authorities’ compliance requirements

Leadership

Ability to lead significant investigations related to Quality Incidents, drive to root cause, product impact, CAPA and timely investigation closure.Ability to lead and engage in complex investigations and propose sound, scientific and compliant resolutions and ensure escalation to the incident management process as required.Ability to support increased organizational investigational capability across sites, regions and OpUs as required.  

Decision-making and Autonomy

A member of the PQ & IM team – contributing to the execution of strategic plans for the function and development of annual goals.Responsible for supporting the increased investigation capabilities across sites/regions and OpUs.

Interaction

Key interactions across all manufacturing and Quality regional and operating unit teamsKey interactions with Supply & Business Excellence to support increased investigation capabilities across the sites/regions/OpU.Key Interactions with the OpU and Region Compliance Leads.Key interactions with the incident management team to ensure timely escalation of significant events/incident and regulatory reporting if required.

Innovation  

A firm grasp of industry, scientific and regulatory trends, understands market conditions, and leverages innovation to evolve Takeda’s profile to become the model for the industry.

Complexity

This is a global role with significant impact on Takeda’s ability to investigate significant and complex manufacturing events and to facilitate timely escalation and decision making. The output from this role and the associated team is applied across the Takeda product portfolio. 

EDUCATION, BEHAVIOURAL COMPETENCIES & REQUIRED SKILLS

Education & Experience

Scientific degree (BSc, MSc)10+ years of experience in the pharmaceutical industry working within the Quality organizationExperience working in an international environmentKnowledge and experience of Bio-Pharmaceutical Manufacturing and the management of complex investigationsDeep knowledge and understanding of international heath authorities’ compliance requirementsFluent in written and spoken English

Core Competencies & Skills

Critical ThinkingCurrent on local and global regulationsDigital and analytical skillsProblem solving, fishbone, DMAICStrong communication skills engaging stakeholders: site, business, network, company, regulatorsRisk identification, evaluation and managementContinuous improvement

Leadership Behaviors

Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trustCreating the environment that inspires and enables peopleFocusing on the few priorities and provide superior resultsElevating site/regional/OpU investigation capabilities for now and the future

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.  

What Takeda Can Offer You

To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Long Term Incentive Plan, Contributory Pension Scheme, Private Health Cover and Life Assurance.

Empowering Our People to Shine

Learn more at takedajobs.com