Head of Quality Control Operations

vor 2 Wochen

Freiburg, Freiburg, Schweiz ARIAD Vollzeit
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization.

It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network.

When you're a part of our team, you'll do meaningful work that makes an impact on the lives of patients.

Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0122282
Date posted 05/03/2024
Location Neuchâtel, Canton of Neuchâtel
Job Title:Head of Quality Control Operations

Location:
Neuchâtel

About the
role:

Directs the Quality Control Laboratories (Microbiology, Biochemistry, Lab SupportandQualitySterilityAssurance)inalargesizeplantanddirectsalarge department to support Facility, Division and Corporate wide initiatives.

Responsibleforperformancesoflabprocesses,resultsintermsofproduct quality and conformance to regulations and Takeda policies.

How you
willcontribute**:

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, outof
- 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,crossfacilityglobal 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 integrit

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