QUALITY MANAGER

Job #: 2279 Pay Rate: Not Specified Job type: contractor Location: New Brunswick, NJ 50% onsite Job Function: The Quality Systems Manager is responsible for implementing, supporting and monitoring the effectiveness of the Quality Systems and Training within the Global External Manufacturing (ExM) organization. Responsibilities: Process Ownership • The Quality Systems Manager will act as end-to-end Local Process Owner of one or more Quality Systems used within Global External Manufacturing • Establish and maintain relationships and communication pathways with Global Process Owners and Global Process Leads for relevant systems • Act as primary ExM representative at Global Community of Practice meetings • Gather stakeholder input from within ExM on any Global Process changes or initiatives and represent the input back into the Global Network • Own all elements of the process including relevant procedures / forms, training materials, SharePoint content, metrics where applicable • Display technical knowledge of the process and understand risks/weaknesses in the system • Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with Client (Client) policies / global procedures where applicable • Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, optimization) for their effectiveness and provide feedback to the Quality management team for action and remediation • Own relevant process issues – speak to trends / issues / exceptions at External Manufacturing Tier 3A and 3B Quality Council. • Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance Processes include Deviation Investigations, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections. Operations Support • The Quality Systems Manager will be responsible for providing day-to-day support to ExM Operations on Quality Systems that enable business objectives to be achieved. This may include: o Processing of Customer Complaint records, including escalation of expedited complaints o Support the processing of deviation investigations, CAPAs and change controls o Perform initial impact assessment of Global change controls that may impact ExM Operations o Participate in Virtual Plant Team (VPT) meetings as appropriate o Support the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMO), as required o Facilitate tracking of CMO Health Authority inspection observations and CAPAs o Escalate any emerging trends / issues to the VPTs, as required. o Provide Quality input ad hoc queries relating to ExM Operations • Support metrics collection and processing, including: o Capture and report on Quality data and metrics for management review and other organizational forums o Utilize data analysis or software skills to build on existing tools to improve the quality system processes o Collect statistical data and compile data for reports; update and assure the accuracy of databases; create management reports; collect, compile, and analyze data and information • Other ad-hoc duties will be required which will include, but not be limited to, the following: o Act as team lead for coordinator of work associated with complaints, change control, deviation, CAPA and document management in the applicable ExM location o Author, review and approve Quality Management System (QMS) documents o Process QMS documents in the electronic document management system o Participate in and support Permanent Inspection Readiness activities o Maintain the Quality Risk Register for ExM o Monitor the periodic review of Quality Systems documents o Maintain the system and process for record management o Maintain the system for update of ExM GxP (Good Practice) Authorizations o Act as ExM Quality Systems representative on ExM and Global Quality projects o Support the scheduling, execution, reporting, follow up and tracking of self-inspections audits o Support preparation of and participate in Quality Council meetings o Perform self-inspection audits as part of the audit team o Identify and implement continuous improvement opportunities for Quality Systems owned processes o Act as qualified training for Quality Systems owned processes • There will be 5% travel associated with this role. Required Competencies Essential • Works under minimum supervision and exhibits a positive work attitude and high productivity • Detail-oriented, well organized and have excellent verbal and written communication skills as well as excellent organization and follow-up skills • Candidate must be flexible and comfortable working in a fast-paced environment with aggressive and dynamic timelines • Excellent interpersonal skills • Ability to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations are required; self-motivated • Strong presentation skills; confident public speaker • Ability to multi-task numerous projects • Ability to achieve targets and milestones • Can prioritize workload based on changing business needs • Ability to recognize topics / decisions requiring escalation • Ability to work with initiative and manage own workload • Proficient in the use of Microsoft Office programs including OneNote and SharePoint platforms • Fluent English is required. • Strong working knowledge of Microsoft Office Required Qualification(s) and Desired Experience Required • A science related degree in Chemistry, Engineering or Biotechnology or equivalent • A minimum of four (4) years' experience in a pharmaceutical Quality related role, preferably within a Quality Systems team • A strong working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global markets • Experience in leading or participation in project teams Desirable • Experience in a GxP Manufacturing site • Lead investigator training #J-18808-Ljbffr