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Quality Assurance Manager

2 months ago

New Brunswick, New Jersey, United States Axelon Services Corporation Full time

Job Overview: 50% onsite

Role Summary:


The Quality Systems Manager is tasked with the implementation, support, and monitoring of the effectiveness of Quality Systems and Training within the Global External Manufacturing (ExM) organization.


Key Responsibilities:

Process Management

  • Serve as the Local Process Owner for one or more Quality Systems utilized within Global External Manufacturing.
  • Foster and maintain communication with Global Process Owners and Global Process Leads for pertinent systems.
  • Represent ExM at Global Community of Practice meetings.
  • Collect stakeholder feedback from ExM regarding Global Process changes or initiatives and relay this information back to the Global Network.
  • Oversee all aspects of the process, including relevant procedures/forms, training materials, SharePoint content, and applicable metrics.
  • Demonstrate technical expertise in the process and identify risks/weaknesses within the system.
  • Ensure compliance of process elements with Regulatory requirements, Health Authority expectations, and Client policies/global procedures where applicable.
  • Regularly assess the process (trends metrics, observations, right first time (RFT), Design, optimization) for effectiveness and provide feedback to the Quality management team for necessary actions and remediation.
  • Address relevant process issues by discussing trends, issues, and exceptions at External Manufacturing Tier 3A and 3B Quality Council.
  • Develop and execute proactive continuous improvement plans for the process, such as 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.


Operational Support

  • Provide daily support to ExM Operations on Quality Systems that facilitate the achievement of business objectives.

This may involve:
o Managing Customer Complaint records, including escalation of urgent complaints
o Assisting in the processing of deviation investigations, CAPAs, and change controls
o Conducting initial impact assessments of Global change controls that may affect ExM Operations
o Participating in Virtual Plant Team (VPT) meetings as necessary
o Supporting risk assessment and mitigation plans for Contract Manufacturing Organizations (CMO), as required
o Tracking CMO Health Authority inspection observations and CAPAs
o Escalating emerging trends/issues to the VPTs, as necessary.
o Providing Quality input for ad hoc queries related to ExM Operations

Support metrics collection and processing, including:
o Capturing and reporting Quality data and metrics for management review and other organizational forums
o Utilizing data analysis or software skills to enhance existing tools for improving quality system processes
o Collecting statistical data and compiling information for reports; updating and ensuring the accuracy of databases; creating management reports; collecting, compiling, and analyzing data and information

Additional duties may include, but are not limited to:
o Acting as team lead for coordinating work associated with complaints, change control, deviation, CAPA, and document management in the applicable ExM location
o Authoring, reviewing, and approving Quality Management System (QMS) documents
o Processing QMS documents in the electronic document management system
o Participating in and supporting Permanent Inspection Readiness activities
o Maintaining the Quality Risk Register for ExM
o Monitoring the periodic review of Quality Systems documents
o Managing the system and process for record management
o Updating ExM GxP (Good Practice) Authorizations
o Serving as ExM Quality Systems representative on ExM and Global Quality projects
o Supporting the scheduling, execution, reporting, follow-up, and tracking of self-inspections audits
o Assisting in the preparation and participation in Quality Council meetings
o Conducting self-inspection audits as part of the audit team
o Identifying and implementing continuous improvement opportunities for Quality Systems owned processes
o Acting as qualified trainer for Quality Systems owned processes

  • This role may involve 5% travel.
Required Competencies Essential

  • Works independently with minimal supervision and demonstrates a positive work attitude and high productivity.
  • Detail-oriented, well-organized, with excellent verbal and written communication skills as well as strong organization and follow-up abilities.
  • Flexible and comfortable working in a fast-paced environment with dynamic timelines.
  • Excellent interpersonal skills.
  • Ability to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations; self-motivated.
  • Strong presentation skills; confident public speaker.
  • Capable of multitasking numerous projects.
  • Ability to meet targets and milestones.
  • Can prioritize workload based on changing business needs.
  • Recognizes topics/decisions requiring escalation.
  • Works with initiative and manages own workload effectively.
  • Proficient in Microsoft Office programs including OneNote and SharePoint platforms.
  • Fluent English is required.
  • Strong working knowledge of Microsoft Office.