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Job Description

About the role:

We're excited to offer a unique opportunity for a Head of Quality Control Operations at our biological site in Neuchâtel. This role entails overseeing the Quality Control Laboratories (Microbiology, Biochemistry, Lab Support, and Quality Sterility Assurance) within a large-scale plant. Additionally, you'll lead a substantial department to drive support for Facility, Division, and Corporate-wide initiatives.

Your responsibilities will include ensuring the efficiency and effectiveness of laboratory processes, as well as delivering results that uphold product quality and compliance with regulations and Takeda policies.

This is a 2 year Contract role (full time).

How youwillcontribute:

Leadership

• LeadstheQClaboratoryfromabudget,organizational,labstrategyandteam development point of view.

• EstablishesaserviceorientedorganizationsupportingglobalpipelineProducts as well as local capacity expansion.

• Develops operational budget for quality control organization. Completesbudgetandadherestobudget/forecast.Continuestoimprove lab efficiency to decrease costs.

• Interactsfrequentlywithalllevelsofinternalmanagementas wellasacross functions and business units.

• Directsorganizationof4to5directreports(Managers)andapproximately70 indirect headcount. Manages overall coaching, training, development and succession plans for the team.

• Createsanenvironmentthatfosterslifelonglearningandagrowthmindset enabling employees to thrive.

• Promotes innovations, digitalization. Foster initiatives that would reduce environmental impact.

• Actively participates in the Global lab strategy.

• Cascades and spreads out the vision, values of Takeda within the QC lab organization.

Operational

• Develops and deploys the quality systems (e.g. laboratory investigations, out-of- specification investigations, assay validation, management review, CAPA, and process control) that ensure products conform to defined requirements.

• Understands and deploys processes to assure conformance to regulations. Actively leads or presents in regulatory inspections.

• Manages interactions with customers and regulators concerning the quality of products, systems and processes.

• Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.

• Oversees the development and implementation of standards, methods, procedures and sampling for inspection testing and evaluating the precision, accuracy and reliability of the product.

• Member of the Quality Lead Team.

• Ensures that products tested on behalf of other Takeda facilities meet with the agreed customer timelines and aligned with OTIF requirements.

• Promotes all actions that make lab operations safe, reliable, compliant and aligned with the standard times.

• Ensures that all Out Of specification or significant atypical trends are investigated and any confirmed out of specification result, or significant negative trend, affecting product batches released on the market are reported to escalate accordingly.

• Owns personal accountability for all EHS aspects, ensuring his team is operating in a safe workplace.

ContinuousImprovement

• Identifies and manages continuous improvement projects that may span multiple sectionsordepartmentswiththeobjectiveofachievingquality,reliabilityandcost improvements.

• EscalatescriticalissuestotheSeniorLeadershipTeam (SLT).

What you bring to Takeda:

• Indepthknowledgeoftheregulatoryenvironmentformanufactureofbiological products. Includes strong knowledge of FDA, EMA, and ICH regulations and USP, EP, JP and ChP requirements.

• Master’sdegreeinScience(MicrobiologyandChemistry).

• Morethe15years experience in Pharmaceutical industry with 10 years in Quality Control and 2 years in Production.

• 15 years management experience.

• Experience with Lims, Lean, Green Belt.

• Strongdriveforcontinuousimprovementactivitieswithinthe lab

• Strong leadership skills and demonstrated success in managing a large team.

• Abilitytobuildlayersofsuccessionwithintheorganizationandatalentpipeline.

• Strong analytical and problem solving skills.

• Excellent verbal and written communicationskills.

• Successworkingwithmultifunctional,cross-facilityglobal teams.

• Excellent interpersonal/communication/influencing/negotiation skills required.

• Demonstrated problem solving skills.

• Musthavethefollowingpersonalattributes:integrityandtrust,workethic,sound judgment, intellectual honesty, pragmatism, courage and conviction.

• Musthavepassiontoinnovateanddriveforsolutions,mustdisplaypersonal accountability for results and integrity.

• Mustdisplayeagernesstolearnandcontinuouslyimprove,musthave uncompromising dedication to quality.

• Musthaverelentlessfocusonrapidanddisciplinedaction,Musthaverespectfor individuals and the diverse contributions of all.

• Criticalthinkinganddemonstratedproblemsolving/rootcauseinvestigation skills.

• Stronganalyticalskills andabilitytosimplifythe complex.

• Strongorganizationalskillsandcontinuousimprovementmind.

• Abilitytothinkoutofthebox,expressthingsorsituationsclearlyand simply.

• Proficiencyinaskingquestions,reformulatingandreconsideringissues.

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