Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Position Responsibilities: This position is within the Global Auditing and Compliance Support team. This team performs comprehensive and risk-based audits to ensure compliance to current good manufacturing practices (cGMP). The Associate Director is responsible for conducting audits (on-site, remote, and questionnaire) of Human Health Sites, Animal Health Sites, Contracted facilities, IT Technology sites, Distribution Centers, Business Partners and Suppliers... Responsible for accepting audit assignments, scheduling, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes. The ideal candidate will have a GMP and IT background to enable them to perform comprehensive GMP audits with a focus on digital solutions, automated manufacturing systems, automated laboratory operations, and analysis of complex datasets to identify quality and compliance risks. The position requires strong communication skills to explain complex quality and compliance gaps in a clear and compelling manner. Strong communication skills are also required for internal and external collaboration with oversight groups, internal sites, and auditees. This position requires strong technical writing skills to generate high quality audit reports. Strong analytical skills and experience with digital analytics tools (e.g. Spotfire, Power BI, Qlik, etc.). Serve as an ambassador for digital auditing tools and contribute to their development. Maintain a broad expertise of cGMP's, our Company Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry including, but not limited to Biologics, Vaccines, IT Technology providers, Medical Devices, Small Molecules, Combination Products, APIs, and Distribution. Obtain and maintain internal and external auditor certification. Maintain awareness of evolving industry and regulatory trends. Support new business opportunities through due diligence and Pre-Contract audits on short notice. Leads initiatives for assigned projects to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet management and regulatory expectations. Education Minimum Requirement: Bachelor’s Degree in Science, Chemistry, Microbiology, Biology, Engineering, Information Technology (or equivalent). Required Experience and Skills: Minimum of 10 years of auditing experience Experience auditing a broad range of auditees including manufacturing, laboratories, and IT technology providers Strong understanding of Quality Management Systems and technical manufacturing processes for drug substances and drug products. Strong understanding of IT Technology solutions which enable drug substance and drug product manufacturing. Strong analytical skills in analyzing systems and datasets to identify quality and compliance risks in drug manufacturing operations. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines. Ability to work independently with limited supervision in a virtual environment. Must have Subject Matter Expertise including knowledge and experience in one or more of the following areas: Biologics, Vaccines, Aseptic/Sterile Drugs, IT Technology, Medical Device, API’s, Non-sterile Drug Product, or Sterile Drug Product manufacturing. Must be a positive change agent and able to adapt in a dynamic environment. Must have the ability to travel globally approximately 50% of the time. Preferred Experience and Skills: Experience in auditing biologics and vaccine manufacturing sites. Experience in auditing IT Technology providers. Experience with development, implementation, and optimization of IT tools to deliver business impact. External engagement in regulatory or industry forums. Prior experience at a health authority performing GMP inspections. Demonstrated ability to establish and maintain collaborative relationships with key stakeholders. Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives. Current Employees apply Current Contingent Workers apply Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): EFL School Director FAO Job Description- Monitor the students’ learning process and actively promote any necessary action to ensure it successfully leads to the achievement of each course objectives, as promised in the British School Group Mission Statement: “The British School Group is Director, Office of Innovation World Food Programme 2202275 Director, Office of Innovation Job Posting: 17/Aug/2022 Closure Date: 20/Sep/2022, 4:59:00 PM Organizational Unit: OIN - Office of Innovation Job Type: Staff position Type of Requisition: Senior-level Grade Level: D-2 Primary Location: Italy-Rome Duration: Fixed Gxp Quality And Compliance Manager Meditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access. Meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators. Our successful track WFP celebrates and embraces diversity. It is committed to the principle of equal employment opportunity for all its employees andencourages qualified candidates to apply irrespective of race, color, national origin, ethnic or social background, genetic Human Resources Associate - Intern TFS TFS HealthScience is excited to be expanding our Human Resources (HR) team and we are looking for an experienced, highly motivated Human Resources Associate - Intern who shares our vision of providing clinical research excellence. Our Human Resources team is a highly Clinical Research Associate Merck Job DescriptionThe role of Clinical Research Associate is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Apheresis & Infusion (Ai) Specialist, Principal Job Description General/Position Summary The focus of this position is to provide educational support to Authorized Treatment Centres (ATCs) with the apheresis & infusion process required as part of the Vertex gene editing therapy. The Principal, Apheresis & Infusion Operational Control Planning and Reporting Stageur Operational Control Planning and Reporting StageurBari - 2 giorni fajobleads.comOperational Control Planning and Reporting StageurINGLombardia - 5 giorni fajobleads.comDurata tirocinio: 6 mesiOperational Control Planning and Reporting StageurING Bank CERTIFICATION ENGINEER Meditrial Europe Ltd. Certification Engineers are assigned staff to the Airworthiness Office, they report hierarchically to COA (Chief of Airworthiness) and they are principally involved in the ETSO Certification Process to:Support Project Engineers for the interpretations of applicable QA/qc Manager Worley Company : WorleyPrimary Location: ITA-LZ-RomeOther Locations: ITA-LO-MilanJob: Project Quality AssuranceSchedule: Full-timeEmployment Type : Agency ContractorJob Level : ExperiencedJob Posting: Apr 23, 2022Unposting Date: May 23, 2022Reporting Manager Title : Project Sr Clinical Site Lead Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and cinfo WFP celebrates and embraces diversity. It is committed to the principle of equal employment opportunity for all its employees and encourages qualified candidates to apply irrespective of race, colour, national origin, ethnic or social background, genetic information, Regional Logistics and Supply Coordinator InterSos INTERSOS Vacancy DetailsJob Title Regional Logistics and Supply Coordinator Code SR-00-7334 Deadline 26/05/2023 Country Head Quarters Duty Station Regional Office for Emergency (Rome, Italy) with up to 50% field missions Starting date 01/06/2023 Contract duration 12 Supply Chain Operations Lead Italy Job DescriptionOrganon is a Women’s Health Company that believes in a better and healthier every day for every woman. We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and Engineer Officer P2 - FIT Pool - All locations World Food Programme .WFP celebrates and embraces diversity. It is committed to the principle of equal employment opportunity for all its employees and encourages qualified candidates to apply irrespective of race, colour, national origin, ethnic or social background, genetic information, Field IMT Infrastructure Officer FAO Org. Setting and ReportingThe incumbent of the post is responsible to the Head Field Information Management Technology Office (H, FIMTO), A18 and receives technical guidance from Chief Technology Development and Operations, P5 at IMTD-HQA.The incumbent supervises a Future Manager Recruitmenttalent.com- Financial Risk Management,- Insurance Risk Management,- Insurance Underwriter,- Financial & Solvency Risk Analyst,Do you have curiosity, a desire to get involved, join a dynamic company, and have the chance to innovate with Sr. Clinical Research Associate Merck Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies Engineer officer - p3 World Food Programme world food programme WFP celebrates and embraces diversity. It is committed to the principle of equal employment opportunity for all its employees and encourages qualified candidates to apply irrespective of race, colour, national origin, ethnic or social background, Associate Director - Quality IT Audit Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across Associate Director Praxi ASSOCIATE DIRECTOR(SENIOR BUSINESS CONSULTANT LEAD)In WTW we provide data-driven, insight-led solutions in the areas of people, risk and capital. Leveraging the global view and local expertise of our colleagues serving 140 countries and markets, we help to sharpen the Supply Chain Associate Director- Drug Product External Manufacturing Lilly We’re looking for people who are determined to make life better for people around the world.Organization Overview:At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help Associate - Quality Assurance Assembly&device Eli Lilly At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need Marketing and Communication Property Director Medical University of South Carolina Marketing and Communication Property DirectorAnantaraRoma - 6 ore fatalent.comJob DescriptionThe Marketing and Communication Property Director reporting to the GM of the hotel will be responsible for all the PR, Communication and MKTG activities, in coordination Director of Development outh Carolina United Methodist Conference UNITED WAY OF COLLIER AND THE KEYS JOB DESCRIPTIONJob Title: Director of DevelopmentReports to: Vice President of PhilanthropyPosition: Full-Time/ExemptLocation: Onsite - Naples, FloridaCompetitive Salary and Benefits PackagePurpose of PositionUnited Way of Associate Finance and Budget Officer Sitly OVERVIEWPost Number: 1ITSC 0886TPGrade: P-2Parent Sector: Natural Sciences Sector (SC)Duty Station: TriesteJob Family: FinancesType of contract: Fixed TermDuration of contract: 2 years with possibility of renewalApplication Deadline (Midnight Paris Time): 12-SEP-2022UNESCO Public Affairs Director - Pharma Medical University Of South Carolina Public Health & Government Affairs ManagerAbbVieStakeholderPrimary : External: Members of Parliament, Public Officials and National and / or Regional Health Bodies, representatives of regional services (pharmaceutical/programming), Trade Associations, Ministry of Executive Associate Belmond Management CALL FOR EXPRESSIONS OF INTEREST - VACANCY ANNOUNCEMENT: 2202245Executive AssociateJob Posting: 12/Aug/2022Closure Date: 09/Sep/2022, 4:59:00 PMOrganizational Unit: DDCCJob Type: Staff positionType of Requisition: General ServiceGrade Level: G-7Primary Location: Customer Success & Logistics Associate Forrester At Forrester' we're trusted to work on trailblazing' mission critical problems that business and technology leaders face today. That's why we're always looking to empower talented individuals to perform at their best every single day. We're proud of our community of smart Staff IT Internal Auditor Becton Dickinson Staff IT Internal Auditor page is loadedStaff IT Internal AuditorApply locations IND Gurgaon - Signature Towers B time type Full time posted on Posted 2 Days Ago job requisition id R-467834Job Description SummaryJob DescriptionBD Internal Audit evaluates the Nurse Manager-Skilled Nursing Job DescriptionJob DutiesInsert “” to classify Essential Function% of Time (must total 100%)1Operations:- Manages and oversees operations of designated business units- Design/implement efficient services, offer revenue enhancements, monitor expenses, CHIEF GROWTH & TECHNOLOGY OFFICER HaysChief Experience Officer (CXO)The Level GroupWe are looking for a Chief Experience Officer to join our executive management team. You will be responsible for continually improving the customer experience and ensuring that the company always follows a Lilly WFP celebrates and embraces diversity. It is committed to the principle of equal employment opportunity for all its employees andencourages qualified candidates to apply irrespective of race, color, national origin, ethnic or social background, genetic Lilly Bari - 5 giorni fajobleads.comCinfoWe are on the lookout for an enthusiastic Engineer Officer P2 to join our diverse team at cinfo in Romeno (TN).Growing your career as a Full Time Engineer Officer P2 is a great opportunity to develop useful skills.If you are strong Associate Director - Quality IT Audit | €110.000 – €125.000 per anno
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