Änderungen in Termin, Kosten und Qualität Sie unterstützen das Customer Management bei der termingerechten Bereitstellung technischer und kommerzieller Grundlagen Sie erfüllen interne sowie Kundenanforderungen unter Berücksichtigung spezifischer Unternehmensvorgaben Sie halten Prozesse, Abläufe und gesetzliche Regelungen ein Sie führen und coachen das Projektteam Sie planen, koordinieren und führen Projekte gemäß Vorgaben durch Sie verantworten die technische und organisatorische Projektabwicklung Sie erstellen Projektdokumentationen und halten Eskalationsstufen ein Mitarbeit an diversen Projekten Ihr Profil: Abgeschlossenes Studium als Ingenieur, Techniker, Betriebswirtschaftler Mehrjährige Erfahrungen als Projektleiter im Projektmanagement Erfahrung in Werkstofftechnik, Verarbeitungstechniken Kunststoff Sehr gute MS-Office Anwendungen, SAP Kenntnisse in Vertragsrecht Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift Gewissenhafte, selbstständige sowie strukturierte Arbeitsweise Durchsetzungsvermögen Teamfähigkeit, Kommunikationsfähigkeit Bereitschaft zur Reisetätigkeit Führerschein B Vorteile für Mitarbeiter: Arbeitskonten mit Gleitzeit Betriebliche Altersvorsorge Vermögenswirksame Leistungen Weiterbildungsmöglichkeiten in der Akademie Moderne Arbeitsmittel Zahlreiche Sonderleistungen von einem attraktiven Vergütungssystem Weihnachts- und Urlaubsgeld Kantine Die advanced engineering GmbH ist seit vielen Jahren erfolgreich darin, Fach- und Führungskräfte an mittelständische Unternehmen und Großkonzerne in den Bereichen Automobiltechnik und Fahrzeugtechnik sowie anderen technischen Branchen in München und Bayern zu vermitteln.
Formulate initial ideas for improvement by leveraging experience and knowledge of processes and systems Produce and validate accurate process map (incl. those generated by team members) Apply advance Lean/Six Sigma/DPDHL First Choice methodologies to focus processes, identifying improvement potential Verifying improvement potential with wider CoD team and process stakeholders Support coordination and coaching of a team of Process Analysts for a specific GBS function (availability dependent)Support the coordination of project engagements for team members Support and coach team members, i.e. review work results and provide feedbackSupport people development activities (e.g. observe team members, identify improvement potentials and support shaping training programs and career development)Support standard setting and shaping best practicesFurther develop standards for process documentation, optimization & redesign, stakeholder management, incorporation of new methodologies and processes into our operating modelContinually monitor for improvement opportunities (e.g. efficiency or quality) in management of the DBPD team and the operating procedures the team adheres toSupport Automation analysts in understanding and assessing potential of processes Brief all aspects of the process to analyst/designer teams where necessary and ensure appropriate touchpoints/updates throughout optimization/redesign processSynthesize business requirements for analyst & designer teamsResponsibility to verify that automation design adheres to business requirementsReview automation design prior and post development to ensure that stakeholder requirements are fulfilled Take ownership of change management activitiesEnsure that BPO team is equipped/trained adequately to communicate process changes in an understandable wayManage relationship with business owners through change management activities as primary contactFacilitate knowledge sharing within CoD & digitization communityShare experience and document lessons learnedHelp further improving our methodology and align on best practices Skills/Qualifications Degree in business management or related discipline with focus on project management/operations management/process design At least four years of relevant project management and or process optimization experience At least four years’ of professional experience in business or related discipline, ideally with a focus on operations management, IT, project management, process improvement or similarExperience in the area of Business Process Optimization, including documentation, analysis, improvement Significant experience in use of recognized project management methodology (e.g.
Your responsibilities: Ensure smooth warehouse operations during assigned shifts Lead, coach, and develop the logistics team Coordinate communication between inbound, outbound, and production departments Maintain quality and safety compliance Plan staff schedules and manage vacation requests Your profile: Initial leadership experience in logistics or warehouse management Experience in a fast-paced warehouse or production setting Willingness to work rotating shifts German or English required (Russian is a plus) Strong organizational skills and hands-on mindset We look forward to receiving your application and will put you in direct contact with your new employer.
Lead and continuously improve the GMP self-inspection program, including annual planning and execution Coach SMEs and audit teams to ensure strong inspection and self-inspection readiness Perform gap assessments on global procedures and drive alignment across site functions Coordinate cross-functional activities and ensure effective communication with all departments Support internal, external, and mock audit preparation, including document review and QA input Act as backroom/ACC or scribe team member during audits and inspections Serve as Data Integrity Champion and ensure consistent DI implementation across the site Prepare and present compliance topics to the Quality Council and site leadership Support continuous improvement initiatives and coordinate operational activities within the compliance team Act as back-up for the Quality Compliance & Systems Expert when required University degree in biochemistry, chemistry, engineering, or another relevant scientific/technical discipline Solid experience in biotechnology and/or pharmaceutical industry Strong knowledge of GMP requirements and Quality Systems Understanding of manufacturing, QC laboratory, and warehouse processes for biological products Solid knowledge of Good Documentation Practices (GDDP) and Data Integrity principles Experience supporting audits and regulatory inspections Skilled in writing, reviewing, and updating SOPs and technical documentation Familiarity with risk management tools (FMEA, RCA, etc.)
Essential Functions Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.Develop contract language, payment language and budget templates as required as applicable to the positionUtilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreementsReport contracting performance metrics and out of scope contracting activities as required.Work with Quality Management to ensure appropriate contract management and quality standards. Mentor and coach colleagues as required including the delivery of training materials as required. Qualifications Bachelor's Degree Related field OR 5-year relevant sponsor or clinical research organization clinical site contracting experienceGood negotiating and communication skills with ability to challenge.Strong legal, financial and/or technical writing skills.Strong understanding of regulated clinical trial environment and knowledge of drug development process.Good understanding of clinical trial contract management.Fluent in English and German language IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Support coordination and coaching of (junior) automation designers Help with the coordination of project engagements for the different team membersSupport and coach team members, i.e. review the work results and provide feedbackSupport people development activities (e.g. observe team members, identify improvement potentials and support shaping individual career development) Independently take on the technical implementation of process automations with UiPath, Bizagi and the use of other digitization tools (Smart OCR, ML, etc.)
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
Support coordination and coaching of a team of automation process analysts for a certain GBS business function (no guarantee, depends on availability) Help with the coordination of project engagements for the different team membersSupport and coach team members, i.e. review the work results and provide feedbackSupport people development activities (e.g. observe team members, identify improvement potentials and support shaping individual career development)Support standard setting and shaping best practicesFurther develop standards for process documentation, optimization & digitization, automation potential estimation, incorporation of new technologies into our technology stack, etc.Observe the software market for process automation, analyze new potential, and define use casesSupport or fully manage digitization projects according to agile methodology depending on size and complexity (for larger and more complex projects there will be a dedicated project manager)Be an advocate for agile project management methodology (empower business functions to fulfil their roles; e.g. product owner)Define initial product backlog in collaboration with the product owner and process expertsWrite user stories for all project activities and estimate efforts in collaboration with process experts and automation designer(s)Define sprint cycles and plan sprintsPlan, host, manage and document sprint review meetings (derive backlog for next sprint)Manage a reasonable scope considering cost & benefitsPrepare status reporting & presentation in team meetingsFacilitate daily stand-ups for project teamIndependently design digital processes of medium to high complexityIndependently check existing process documents and revise/provide details together with process experts, considering best practices (BPMN 2.0)Independently analyze processes with regard to their automation potentialIndependently optimize processes at task level and develop a digital target process in close coordination with automation designersPresent process design to senior stakeholdersEnsure buy-in of key stakeholders (automation designer, process experts, process owner)Support the automation designers intechnical implementationProvide instructions to automation designer and assist during technical implementationSupport integration and user acceptance testIndependently define and perform test cases with process expertsSupport test coordination and create test documentationSupport go-live and hypercare phase (e.g. conduct trainings and provide coaching)Support change management activitiesPresent and communicate process changes in an understandable wayEnsure that users understand and take account of technical process changesFacilitate knowledge sharing within CoD & digitization communityShare experience and document lessons learnedHelp further improving our methodology and align on best practicesSupport special CoD-relevant projects (i.e. technology exploration)In parallel to your project engagement, you may be involved into special projectsSpecial projects vary (i.e. exploring new technologies, certain methodology improvement initiatives, internal or external auditing, etc.)
Independently manage a team of cross-function automation process analystsYearly target setting and reviewCoordinate project engagements according to defined digitization roadmapSupport and coach team members, i.e. review the work results and provide feedbackSupport people development activities (e.g. observe team members, identify improvement potentials and support shaping individual career development)Accountable for standard setting and shaping best practicesFurther develop standards for process documentation, optimization & digitization, automation potential estimation, incorporation of new technologies into our technology stack, etc.Observe the software market for process automation, analyze new potential, and define use casesSupport or fully manage digitization projects according to agile methodology depending on size and complexity (for larger and more complex projects there will be a dedicated project manager)Be an advocate for agile project management methodology (empower business functions to fulfil their roles; e.g. product owner)Define initial product backlog in collaboration with the product owner and process expertsWrite user stories for all project activities and estimate efforts in collaboration with process experts and automation designer(s)Define sprint cycles and plan sprintsPlan, host, manage, and document sprint review meetings (derive backlog for next sprint)Manage a reasonable scope, considering cost & benefitsPrepare status reports and present in team meetingsFacilitate daily stand-ups for project teamIndependently design digital processes with medium to high complexityIndependently check existing process documents and revise/provide details together with process experts, considering best practices (BPMN 2.0)Independently analyze processes with regard to their automation potentialIndependently optimize processes at task level and develop a digital target process in close coordination with automation designersPresent process design to senior stakeholdersEnsure buy-in of key stakeholders (automation designer, process experts, process owner)Support the automation designers for the technical implementationProvide instructions to automation designer and assist during technical implementationSupport integration and user acceptance testIndependently define and perform test cases with process expertsSupport test coordination and create test documentationSupport go-live and hypercare phase (e.g. conduct trainings and provide coaching)Support change management activitiesPresent and communicate process changes in an understandable wayEnsure that users understand and take account of technical process changesEnsure and facilitate knowledge sharing within CoD & digitization communityShare experience and document lessons learnedFacilitate knowledge exchange sessionsSupport special CoD-relevant projects (i.e. technology exploration)Alongside your project engagement, you may be involved into special projects (i.e. exploring new technologies, certain methodology improvement initiatives, internal or external auditing, etc.)