D06 - QLTY ASSURANCE METHODS / QA METHODS MGMT - QUALITY MANAGER - Advent Global Solutions
New Brunswick, NJ 08903-0191
About the Job
Job Description: 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) 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
Additional Job Requirements:
None
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) 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
Additional Job Requirements:
None
Source : Advent Global Solutions
