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Quality Assurance Manager

2 months ago

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

Job Description: 50% onsite

Job Function:


The Quality Systems Manager is tasked with executing, facilitating, and assessing the efficacy of the Quality Systems and Training within the Global External Manufacturing (ExM) organization.


Responsibilities:

Process Ownership

  • The Quality Systems Manager will serve as the comprehensive Local Process Owner of one or more Quality Systems utilized within Global External Manufacturing.
  • Establish and nurture relationships and communication channels with Global Process Owners and Global Process Leads for pertinent systems.
  • Represent ExM as the primary delegate at Global Community of Practice meetings.
  • Collect stakeholder feedback from within ExM regarding any Global Process modifications or initiatives and relay this feedback back into the Global Network.
  • Own all components of the process including relevant procedures/forms, training materials, SharePoint content, and applicable metrics.
  • Exhibit technical expertise of the process and comprehend risks/weaknesses within the system.
  • Ensure that all elements of the process comply with Regulatory requirements, Health Authority expectations, and Client policies/global procedures where applicable.
  • Regularly evaluate the process (trends metrics, trends observations, right first time (RFT), Design, optimization) for effectiveness and provide insights to the Quality management team for action and remediation.
  • Manage relevant process issues – address trends/issues/exceptions at External Manufacturing Tier 3A and 3B Quality Council.
  • Develop and execute proactive continuous improvement strategies for the process, such as Value Stream Mapping and identification of weak elements, regulatory surveillance.


Processes encompass 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 accountable for delivering daily support to ExM Operations on Quality Systems that facilitate the achievement of business objectives.

This may include:
o Managing Customer Complaint records, including the 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 the risk assessment and mitigation strategies of Contract Manufacturing Organizations (CMO), as required
o Overseeing tracking of CMO Health Authority inspection observations and CAPAs
o Escalating any emerging trends/issues to the VPTs, as necessary.
o Providing Quality input for ad hoc inquiries related to ExM Operations

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

Additional ad-hoc duties will be required which may include, but are not limited to, the following:
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 Maintaining the system for updating ExM GxP (Good Practice) Authorizations
o Acting 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 training for Quality Systems owned processes

  • There will be 5% travel associated with this role.
Required Competencies Essential

  • Works under minimal supervision and demonstrates a positive work attitude and high productivity.
  • Detail-oriented, well-organized, and possesses excellent verbal and written communication skills as well as exceptional organization and follow-up abilities.
  • Candidate must be adaptable 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 is required; self-motivated.
  • Strong presentation skills; confident public speaker.
  • Capability to multitask 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.