What are the responsibilities and job description for the Hiring: Quality Manager || New Brunswick, NJ || Hybrid position at Sunrise Systems?
Job Title : Quality Manager
Duration : 12 Month Contract (Possible extension based on work performance)
Location : New Brunswick, NJ
Job Description : Must Have :
- Experience with handling product complaints, change control and documentation in pharmaceutical / medical industry.
- Preferred experience in infinity / Veeva Vaul t
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
Processes include Deviation Investigations, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections.
Operations Support
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
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
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
Required Competencies Essential
Required Qualification(s) and Desired Experience Required
Desirable
