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Director, Sterile and Microbiology Quality Assurance Job Berlin Germany,  

Posted on : 22 April 2017

Project Description

Director, Sterile and Microbiology Quality Assurance-QUA005810DescriptionMSD is a global health care leader with adiversified portfolio of prescription medicines, vaccines and animal healthproducts. The difference between potential and achievement lies in the sparkthat fuels innovation and inventiveness; this is the space where MSD has codifiedits 125-year legacy. MSD s success is backed by ethical integrity, forwardmomentum, and an inspiring mission to achieve new milestones in globalhealthcare.TheDirector, Sterile & Microbiology Quality Assurance is responsible forproviding leadership and direction for microbiology testing, MicrobiologyLaboratory, and related topics in sterile, non-sterile, biologic manufacturingfor assigned topics. Leads the development, deployment and maintenance ofmultiple divisional quality standards or SOP to ensure MMD is compliant tocGMPs for these topics. Serves as the Sterile and Microbiology QA pointof contact for multiple sites in the MMD network. Leads divisionalprojects across internal and/or external sites.1. Asthe Sterile and Microbiology QA lead for specific topics, is responsible fora) Identifyingthe regulatory requirements and cGMP expectations.b) Developing,authoring, and maintaining the divisional quality standards in alignment withregulatory requirements and cGMP expectations.c) Deployingand ensuring consistency in sites meeting the standards for the topic (e.g.providing training, supporting gap assessments, reviewing remediation plans andvariances).d) Trackingmetrics for MMD network sites to meet the divisional standards, whereapplicable.e) Definingand tracking quality metrics to transform performance at MMD network sites, whereapplicable.f) Providingsupport to CMC when questions arise from regulators during review of filings.g) Organizingand facilitating compliance related communities of practiceh) RepresentingMSD in external forums, conferences, and working groups such as ISPE, PDA,PhRMA, or USP.2. Asthe Sterile and Microbiology point of contact for a manufacturing area ormicrobiology lab, is responsible fora) Understandingthe compliance gaps and quality improvement goals for microbiology topics.b) Coordinatingglobal microbiology team support for prioritized topics.c) Workingwith the sites and regional QO to ensure consistency and alignment tomicrobiology topics.3. Leadscross functional teams toa) Transformthe compliance and/or quality for microbiology topics in the manufacturingareas, laboratories, or interfacing with Research.b) Developof maintain a collection of Quality Standardsc) Understandand/or influence regulatory or industry standardsProvidesexpert support to sites related regulatory inspections, development ofresponses to inspection observations, significant investigations, and guidanceregarding corrective actionsQualifications- B.S.,M.S. and/or Ph.D. preferably in Science or Engineering such asMicrobiology, Biochemical EngineeringRequiredExperience and Skills:- Aminimum of 10 years  experience in the pharmaceutical, biopharmaceutical,vaccine, or medical device industry.- Expertknowledge of EMEA, MHRA, and FDA regulations- Experienced with USP, EP, and BP andISP industry standards- Expertknowledge of Microbiological Laboratory & Microbiology Testing- Highlyexperienced in regulatory inspection and responses.- Highlyexperienced in listening to and gathering a range of perspectives and withability to develop solutions and champion a position.- Excellentwritten and oral communicatorPreferredExperience and Skills:- Advanceddegree desirable.- Expertknowledge of three or more microbiology topics related to sterile,non-sterile, or biologic processing and/or microbiology methods- Expertknowledge of international GMPs and Quality Management requirements ofvarious regulatory agencies that may include US FDA, EMEA, TGA, HPB,ANVISA, COFEPRIS, ANMAT, KFDA and PMDA.- Knowledgeof worldwide compendia and ISO industry standards.- Directexperience working as part of a regulatory agency or on USP MicrobiologyExpert Committee or equivalent- Demonstratestolerance for ambiguity.- Goodteacher- Hands-onand relates well with the shop floor and laboratory technicians .- QualityRisk Management- ChangeExecution Management- ProjectManagementYour role at MSD is integral to helping the world meetnew breakthroughs that affect generations to come, and we re counting on yourskills and inventiveness to help make meaningful contributions to globalmedical advancement. At MSD, we re inventing for life.Job: Qual Assurance & Ops Generic Job Title:Dir, Quality AssurancePrimary Location: EMEA-Germany-BE-BerlinOther Locations: Europe, Middle East & AfricaEmployee Status: RegularTravel: Yes, 50 % of the TimeNumber of Openings: 1Shift (if applicable): 1stExternal Job Board Posting: Switzerland - Jobs.chCompany Trade Name:MSD Job Segment: Biochemistry, Microbiology, Medical, Medical Technologist, Manager, Science, Healthcare, Management


Berlin, DE

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