Quality Assurance Manager

4 weeks ago

New Brunswick, United States Integrated Resources, Inc ( IRI ) Full time

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:

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, including:

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


Other ad-hoc duties will be required which will include, but not be limited to, the following:

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


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

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