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Associate Director Headquarters Clinical Quality Management

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Rahway, NJ

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u003Cbu003ERequisition ID: u003C/bu003ECLI007453u003Cbru003Eu003Cbru003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003EMerck u0026amp; Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified itsu00a0u003C/fontu003Eu003Cfont face=arial\u003Eu003Cfont size=2\u003Elegacy for over a centuryu003C/fontu003Eu003C/fontu003Eu003Cfont size=2 face=Arial\u003E. Mercku2019s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.u003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003Eu003Cbru003Eu003C/fontu003Eu003Cfont size=2 face=Arial\u003EMerck is on a quest for cures and is committed to being the worldu2019s premier, most research-intensive biopharmaceutical company. Today, weu2019re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Mercku2019s leading discovery capabilities and world-class small molecule and biologics Ru0026amp;D expertise to create breakthrough science that radically changes the way we approach serious diseases.u00a0u003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003Eu003Cbru003Eu003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003EIt is business critical that Merck receives consistent and accurate high quality data from investigational sites around the globe.u00a0 Under the guidance of HQ CQM Lead, Director, the HQ CQM, AD will oversee clinical quality management within the Therapeutic Area supporting Clinical Trial Teams (for in or outsourced trials) to proactively embed quality into Merck sponsored trials, ensure adequate vendor oversight for outsourced trials and address any quality issues as needed.u00a0u003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003Eu003Cbru003Eu003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003EThe incumbent will be responsible for the development of Quality Plans to implement Quality by Design within Clinical Development Programs, using a risk based approach and collaborating in implementing, and executing of the Quality Control activities at Headquarters (e.g. through central monitoring) as well as in the GCTO countries (e.g. through targeted QCVs at selected sites).u00a0u003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003Eu003Cbru003Eu003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003EThe incumbent will work with employees from all areas within and outside GCTO and will manage and / or co - lead key initiatives charged with executing the continuous improvement initiatives in Clinical Research.u003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003Eu003Cbru003Eu003C/fontu003Eu003Cfont size=2 face=Arial\u003EOverarching Responsibilities:u003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cfont size=2\u003EProvides real - time, proactive advice and guidance on procedures and issues relating to Quality, Compliance and Global Processes related to clinical development program management, clinical trial activities and vendor oversight.u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003ESupports creation of the Quality Plan and performs quality data review for Clinical Development Programs that are prioritized according to the Book of Business and in agreement with CSSM Heads and Clinical Therapeutic Area Heads.u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EFacilitates appropriate quality issue escalation and resolution in accordance with all applicable change management processes.u003C/fontu003Eu003C/liu003Enu003C/ulu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003EAudit and Inspection Support:u003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cfont size=2\u003EDevelops and maintains Story Boards for Clinical Development Programs and pivotal clinical trials to implement a risk based mitigation approach in view of inspection readiness.u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003ESupports the Global Inspections Management group, as part of preparation support teams for trial - related sponsor and / or site related inspections.u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003ESupports the development of responses to audits and inspections and ensures appropriate CAPA implementation.u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EEnsures that all actions and commitments are implemented in a timely manner.u003C/fontu003Eu003C/liu003Enu003C/ulu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003EQuality Signal Detection:u003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cfont size=2\u003ESupports Therapeutic Area staff with in depth knowledge of current audit and inspection trends across and within programs.u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EDevelops, implements and analyzes TA specific holistic quality plans (risk based approach) to detect quality signals before they are identified as audit observations and / or inspection findings.u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EDevelops and manages targeted QCVs, including the analysis and development of appropriate action plans in agreement with defined thresholds.u003C/fontu003Eu003C/liu003Enu003C/ulu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003EQuality Signal Analysis:u003Cspan style=WHITE-SPACE: pre\u003Eu003C/spanu003Eu003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cfont size=2\u003EProvides processes, systems and knowledge needed to proactively disseminate known and potential quality issues from local / regional to global perspective.u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003ESupports QCI Management and Therapeutic Area staff by providing an ongoing consolidation and current overview of known issues.u003C/fontu003Eu003C/liu003Enu003C/ulu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003EQuality Issue Prevention:u003C/fontu003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cfont size=2\u003EDeploys and maintains global Quality Information management tools (e.g. Story Boards) to track and trend issues as well as manage them through their implementation life - cycle.u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EImplements a Quality by Design approach from initial Protocol through Clinical Study Report.u00a0u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EProvides input and approves trial specific monitoring plansu003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003ESupports qualification and quality management of global vendors.u003C/fontu003Eu003C/liu003Enu003C/ulu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003Cfont size=2 face=Arial\u003Eu003C/fontu003Eu003C/pu003Eu003Cbu003EQualificationsu003C/bu003Eu003Cbru003Eu003Cbru003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003EEducation Minimum Requirement:u003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cfont size=2\u003EBachelor's Degreeu00a0in relevant Health Care areau00a0u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EA minimum of 5 years of relevant experience in clinical research including direct field monitoring experience or management / oversight of such individuals, with a demonstrated record of accomplishments.u003C/fontu003Eu003C/liu003Enu003C/ulu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003ERequired Experience and Skills:u00a0u003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cfont size=2\u003EDirect experience in quality management, GCP Auditing and GCP Inspections.u00a0u00a0u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EExperience with completing risk assessmentsu003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EExperience delivering effective CAPA management solutions.u003C/fontu003Eu003C/liu003Enu003C/ulu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003EPreferred Experience and Skills:u003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003C/pu003Eu003Culu003Enu003Cliu003Eu003Cfont size=2\u003ESuperior oral and written communication skills in an international environment.u00a0u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EExcellent teamwork and leadership skills, including conflict resolution expertise and discretion.u00a0u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EAbility to analyze, interpret, and solve complex problems.u00a0u003C/fontu003Eu003C/liu003Enu003Cliu003Eu003Cfont size=2\u003EAbility to think strategically and objectively and with creativity and innovation.u003C/fontu003Eu003C/liu003Enu003C/ulu003Eu003Cp style=MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px\u003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003EYour role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and weu2019re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, weu2019re inventing for life.u00a0u003C!--?xml:namespace prefix = o /--u003Eu003Cpu003Eu003C/pu003Eu003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003Eu00a0u003Cpu003Eu003C/pu003Eu003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003Eu003Cfont color=black size=2\u003EIf you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request tou003C/fontu003Eu003Ca href=mailto:****\****u003C/au003E. u003Cpu003Eu003C/pu003Eu003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003Eu00a0u00a0u003Cpu003Eu003C/pu003Eu003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003Eu003Cbu003ESearch Firm Representatives Please Read Carefully:u00a0u003C/bu003Eu003Cpu003Eu003C/pu003Eu003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003EMerck u0026amp; Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.u00a0 Please, no phone calls or emails.u00a0 All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.u00a0 No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.u003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003Eu00a0u003Cpu003Eu003C/pu003Eu003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003EFor more information about personal rights under Equal Employment Opportunity, visit:u003Cpu003Eu003C/pu003Eu003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003Eu00a0u003Cpu003Eu003C/pu003Eu003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003Eu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u003Ca href=****target=_blank\u003Eu003Cfont color=blue\u003EEEOC Posteru003C/fontu003Eu003C/au003Eu003Cpu003Eu003C/pu003Eu003C/fontu003Eu003C/pu003Eu003Cp class=MsoNormal style=MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0px; LINE-HEIGHT: normal\u003Eu003Cfont size=2\u003Eu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u003Ca href=****target=_blank\u003Eu003Cfont color=blue\u003EEEOC GINA Supplementu00a0u003C/fontu003Eu003C/au003Eu003C/fontu003Eu003C/pu003Eu003Cbru003Eu003Cbru003Eu003Cbu003EJob: u003C/bu003EClinical Research Genericu003Cbru003Eu003Cbu003EOther Locations: u003C/bu003EUpper Gwynedd, PA, US u003Cbru003Eu003Cbu003EEmployee Status: u003C/bu003ERegularu003Cbru003Eu003Cbu003ETravel: u003C/bu003EYes, 20 % of the Timeu003Cbru003Eu003Cbu003ENumber of Openings: u003C/bu003E1u003Cbru003Eu003Cbu003EShift (if applicable): u003C/bu003Eu003Cbru003Eu003Cbu003EHazardous Materials: u003C/bu003ENoneu003Cbru003Eu003Cbu003ECompany Trade Name: u003C/bu003EMerck,datePosted:2018-07-13,employmentType:FULL_TIME,industry:null,hiringOrganization:{@type:Organization,name:Merck USA},identifier:{@type:PropertyValue,name:Merck USA,value:CLI007453-en_US},jobLocation:{@type:Place,address:{@type:PostalAddress,addressCountry:US,streetAddress:,addressLocality:Rahway,addressRegion:NJ,postalCode:07065}}}

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