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Sr Manager, External Quality Job Shanghai China,  

Posted on : 10 April 2017

Project Description

Sr Manager, External Quality-QUA005370DescriptionPositionOverview - Basic Functions & ResponsibilityIndividual contributorresponsible to implement Quality Operations (Quality Assurance and QualityControl) policy and discharge all QO responsibilities supporting external parties/partnersand alliances (EP s) for manufacture, testing, packaging, storage, anddistribution of API intermediates, API, non-sterile pharmaceutical products underthe direction or on behalf of the Executive Director EQA. These activitiesinclude assuring that products are produced from approved processes inconformance to all applicable regulatory requirements and Company policies andmay include the release of all manufactured products. The incumbent will exercise a leadership rolein monitoring and maintaining the EP s compliance with the FDC Act, CurrentGood Manufacturing Practices Regulations (domestic and foreign), and otherpertinent legal requirements. The incumbent ensures the quality performance of EP sthrough direct oversight, support and technical advice, counselling to the EPsite senior leadership and providing on-site supervision as appropriate. This includes overseeing activities such as EPselection on a needed basis, GMP Due Diligence, and establishing QualityAgreements.Possesses a uniquecombination of analytical and scientific skills in order to effectively manageand control all activities necessary for support of a Quality Operationsprogram governing for manufacture, testing, packaging, storage, anddistribution of sterile pharmaceutical products, API intermediates, API,non-sterile pharmaceutical products in conjunction with and under the directionof the Executive Director EQA. Receivesguidance on policy issues and direction with regard to operations, butfunctions independently. Activitiesinclude:PrimaryActivities1.Assuresthat the Quality Operations department of the EP operates within establishedpolicies and procedures of the Division and Corporation and complies with allapplicable governmental regulations (GMP, etc.), both domestic and foreign.2.Assuresthe development and maintenance of a Quality Agreement with the EP s. Provides input into the development ofcontractual agreements with the EP s.3.Executesa program of calibratedQuality oversight based on the product type, capabilities, and quality andcompliance performance of the EP.4.Aprincipal responsibility in oversight of an EP may involve releasing pharmaceuticalproducts, API intermediates, API, non-sterile pharmaceutical products to othersites and/or to the market with the assurance that the goods were produced inconformance to all applicable policies and procedures of Merck and compliancewith all governing regulations. Beforeshipment, he/she will assure that products manufactured by the plant have thecorrect quality and identity, meet all pertinent specifications and specialrequirements, and have been produced by approved processes and under properconditions.5.Has responsibilityfor Quality assurance and control functions to include direct support to EP s,coordination and oversight for product testing, as well as other relevantcomponents as determined by applied calibrated Quality oversight. These components may include review of batchdocumentation and deviation investigations.6.Has responsibilityfor maintenance and oversight of ongoing supplier performance management toinclude regulatory inspection support and monitoring, internal complaintmanagement, internal customer feedback coordination, and review of annualproduct reviews.7.Reviewsall audit outcomes pertaining to the EP s and ensures appropriate and timelycorrective actions are identified and implemented.8.Monitorsefforts to improve the EP s quality and reliability through ongoing oversightand formal communication programs and forums.9.Providessupport to the EP s to facilitate and validate new product introductions. Provides compliance input and support, asappropriate for implementation of analytical methodology and processdevelopment initiatives. In conjunctionwith other internal Merck departments (ACDS-SAS, GPC, EMT), ensures that EP sare inspection ready for all new product introductions or transfers.10. Provides support and develops presentations forQuality Council meetings. Providesoversight for presentation content and may support issuance of minutes.11. Assists in the coordination of significantinvestigations including Fact Findings. Assistsin the coordination of product recalls as needed.12. Operates in a safe and efficient manner andin compliance with the MMD Q.O. Safety and Health Policy.13. Conducts quality due diligence assessmentsfor pre-approval considerations of new EP s. Supports the EP in remediation ofdue diligence and pre-contract audit gaps.Assures the development and maintenance of a Quality Agreement with the EP. Acts as the Quality expert on Merck's behalfregarding contractual negotiations and provides input into the development ofcommercial contractual agreements with the EP on quality related terms.14. May act as or support the regulatorycompliance liaison on MSD s behalf to interface with regulatory agencies.Closely collaborates with appropriate business andoperations areas to achieve MMD and MSD objectives.QualificationsSkillsBS Biology,Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent)preferred. Expertise in API (sterile API or Non-sterile API) manufacturingprocesses and quality systems. Must have strong knowledge of and broadexperience in Quality Assurance and Quality Control activities. Must have strong demonstrated communicationand relationship building skills. Mustbe conversant with all domestic and foreign regulations and compendia governingplant operations. Some level ofcontractual and financial awareness is required.Job: Qual Assurce - 3rd Party Manuf Job Title:Assoc. Dir, External QualityPrimary Location: APAC-CN-31-ShanghaiEmployee Status: RegularNumber of Openings: 1Company Trade Name:MSD Job Segment: Microbiology, Developer, Engineer, Law, Manager, Science, Technology, Engineering, Legal, Management


Shanghai, CN

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