About us Our Business Unit Lighting and Imaging offers smart solutions for light delivery and image transmission in demanding environments — from medical devices, industrial, and safety applications to aviation and automotive. With manufacturing sites in Europe and North America, and supported by SCHOTT’s global sales network, we are a leading supplier of high-quality fiber optic and LED components.
Purpose As a Therapeutic Strategy Lead, you’ll develop and implement effective delivery strategies tailored to customer needs during the RFP/Bid Defense cycle. You’ll bridge the gap between sales, medical, and operational teams to ensure seamless project execution and support sales teams throughout the Business Development process.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
About us Your Contribution Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholdersLead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global EngineeringManage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accurals; deliver fiscal year plan on time and on budgetPrepare and maintain audit ready documentation aligned to US cGMPOperate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control StrategyOwn change controls (local and global)- initiaiton, risk assessment, execution plan, verification of effectivensss and closure Lead/support validation and qualification for equipment, products, processes, etc.Integrate into operations; plan trials and downtime, coordinate line readiness/tech transfer, create/update SOPs, define PM requirements and maintenance plans, ensure spares/training are in placeSupport quality investigationsDrive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle times Mentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where needed Promote safety and EHS and adhere to all Company policies, procedures and guidelines Your Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach
Mitwirkung bei verschiedenen Projekte der Bereiche Qualitätssicherung und GMP direkt bei unseren Kunden vor Ort mit Unterstützung namhafte Hersteller im GMP-regulierten Umfeld (Pharma, Biotechnologie, Life Sciences, Medical Devices, Chemie) bei der Erfüllung ihrer Qualitätsansprüche und Entwicklung neuer Lösungsansätze Qualifizierung von Anlagen und Validierung von Prozesse nach den neuesten Methoden und messtechnischen Standards als Projektkoordinator:in oder -leiter:in auch Verantwortung Projekten Durchführung des Hygienemonitoring im Rahmen des Hygienemanagements Sie sind Betreuer:in und Berater:in für die vielfältigen Fragestellungen in der Qualitätssicherung und GMP-Compliance Ihr Profil: abgeschlossenes Ingenieurstudium (Master, Bachelor, Promotion) der Fachrichtungen Chemie, Pharmatechnik, Biotechnologie, Verfahrenstechnik oder einer vergleichbaren naturwissenschaftlichen Fachrichtung sowie Erfahrung mit dem Schwerpunkt von Prozessvalidierungen im Bereich Medizinprodukte, biologische Produkte oder Pharmazeutika Reisebereitschaft (40 %), sehr gute Deutsch- und Englischkenntnisse Sicherer Umgang mit den gängigen SAP und MS Office-Programmen als ein:e Macher:in oder ein:e ‚Anpacker:in‘ und haben Sie ein freundliches und Service orientiertes Auftreten hohes Maß an Selbstständigkeit, Engagement und Teamspirit sowie Bereitschaft Verantwortung zu übernehmen Freude Haben wir Ihr Interesse geweckt?
About us Your Contribution Lead, coach, and motivate employees within respective area of responsibility, while providing direction to achieve department goals and objectivesAssist in developing department budget and investment plan(s) according to strategic goalsCultivate employee talent through training and coaching measures, while also conducting employee performance reviewsSupport the development and updating of Quality Assurance programs, policies, processes, procedures and controlsReview, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepanciesManage the review of batch records and avoid impacting shipment datesManage Department Training Coordinator activities and projectsManage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documentsLead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirementsMeasure and analyze Quality System trendsOversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)Maintain the Archive Room and document retention requirementsWrite and revise Standard Operating Procedures (SOPs) and provide training, as requiredManage the CAPA and Change-Control process to include, issuing, reviewing and approving stepsSupport all customer or registrar quality related audits and/or evaluationsUtilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business UnitManage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findingsHelp promote and implement safety/EHS directives and maintain a clean and safe workspaceAssure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines Your Profile Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, requiredMinimum three years of experience in Quality leadership roleSolid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISOExposure to the glass forming industry and/or pharmaceutical industry, preferredThorough MS Office applications, SAP and electronic QMS systemsMulti-tasking abilitiesDecision makingDetail oriented approachForward/creative thinkingService orientedEffective communication skillsAbility to read, write and speak English language Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Bachelor’s Degree in Chemistry, Biology, Engineering or science related field, requiredMinimum three years of experience in Quality leadership roleSolid knowledge of ISO 9001, 14001, 15378, along with cGMP and ISOExposure to the glass forming industry and/or pharmaceutical industry, preferredThorough MS Office applications, SAP and electronic QMS systemsMulti-tasking abilitiesDecision makingDetail oriented approachForward/creative thinkingService orientedEffective communication skillsAbility to read, write and speak English language
Strong analytical and problem-solving skills. Ability to travel up to 30%. Benefits Medical, Dental, and Vision insurance available after 30 days of employment. Generous Educational Reimbursement program. Company-sponsored Life and Disability Insurance.
Strong analytical and problem-solving skills. Ability to travel up to 30%. Benefits Medical, Dental, and Vision insurance available after 30 days of employment. Generous Educational Reimbursement program. Company-sponsored Life and Disability Insurance.
We know: motivated and committed employees are the precondition for the success of our company. Further training and education; Free Parking; Medical, Dental and Vision coverage; Talent development; Team Events; paid vacation days, holidays and sick time Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future.
We will consider all qualified applicants without regard to race, color, creed, religion, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity and expression (including transgender status), sexual orientation, marital status or status as a victim of domestic violence, national origin, ancestry, citizenship status, age, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, military service or veteran status, or any other classification protected by applicable local, state, and federal laws.
ERP experience required, SAP experience preferred Ability to communicate and collaborate with all managerial levels of a global organization. Benefits Medical, Dental, Vision insurance offered at 30 days of employment Generous Educational Reimbursement program Company sponsored Life and Disability Insurance Paid Time Off Ten (10) Paid Holidays per year 401K with Company Match Location: Waukesha ǀ Wisconsin ǀ USA
We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma.
ERP experience required, SAP experience preferred Ability to communicate and collaborate with all managerial levels of a global organization. Benefits Medical, Dental, Vision insurance offered at 30 days of employment Generous Educational Reimbursement program Company sponsored Life and Disability Insurance Paid Time Off Ten (10) Paid Holidays per year 401K with Company Match Location: Waukesha ǀ Wisconsin ǀ USA
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.