What are the responsibilities and job description for the Quality Manager position at Cynet Systems?
Job Description:
Pay range: $42hr - $45hr
Responsibilities:
Pay range: $42hr - $45hr
Responsibilities:
- The Quality Systems Manager will act as end-to-end Local Process Owner of one plus 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 company 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.
- 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.
- Processing of Customer Complaint records, including escalation of expedited complaints.
- Support the processing of deviation investigations, CAPAs and change controls.
- Perform initial impact assessment of Global change controls that may impact ExM Operations.
- Participate in Virtual Plant Team (VPT) meetings as appropriate.
- Support the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMO), as required.
- Facilitate tracking of CMO Health Authority inspection observations and CAPAs.
- Escalate any emerging trends / issues to the VPTs, as required.
- Provide Quality input ad hoc queries relating to ExM Operations.
- Support metrics collection and processing.
- Capture and report on Quality data and metrics for management review and other organizational forums.
- Utilize data analysis or software skills to build on existing tools to improve the quality system processes.
- 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.
- Act as team lead for coordinator of work associated with complaints, change control, deviation, CAPA and document management in the applicable ExM location.
- Author, review and approve Quality Management System (QMS) documents.
- Process QMS documents in the electronic document management system.
- Participate in and support Permanent Inspection Readiness activities.
- Maintain the Quality Risk Register for ExM.
- Monitor the periodic review of Quality Systems documents.
- Maintain the system and process for record management.
- Maintain the system for update of ExM GxP (Good Practice) Authorizations.
- Act as ExM Quality Systems representative on ExM and Global Quality projects.
- Support the scheduling, execution, reporting, follow up and tracking of self-inspections audits.
- Support preparation of and participate in Quality Council meetings.
- Perform self-inspection audits as part of the audit team.
- Identify and implement continuous improvement opportunities for Quality Systems owned processes.
- Act as qualified training for Quality Systems owned processes.
- There will be 5% travel associated with this role.
- 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.
- Strong working knowledge of Microsoft Office.
- A science related degree in Chemistry, Engineering or Biotechnology or equivalent.
- A minimum of four years’ experience in a pharmaceutical Quality related role, preferably within a Quality Systems team.
- Experience in leading or participation in project teams.
- Experience in a GxP Manufacturing site.
- Lead investigator training.
Salary : $42 - $45
