Quality Systems Lead

2 weeks ago

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

Job Function:

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

Key Responsibilities:

Process Ownership

The Quality Assurance Manager will serve as the Local Process Owner for various 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.

Act as the primary ExM representative during Global Community of Practice meetings.

Collect stakeholder feedback from within ExM regarding any Global Process modifications or initiatives and relay this input back to the Global Network.

Oversee all aspects of the process, including relevant procedures/forms, training materials, SharePoint content, and applicable metrics.

Exhibit technical expertise in the process and identify risks and weaknesses within the system.

Ensure that all elements of the process comply with Regulatory requirements, Health Authority expectations, and Integrated Resources, Inc. policies/global procedures where applicable.

Regularly assess the process (trend metrics, observations, right first time (RFT), design, optimization) for effectiveness and provide constructive feedback to the Quality management team for action and remediation.

Manage relevant process issues by addressing trends, issues, and 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, along with 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 Assurance Manager will provide daily support to ExM Operations concerning Quality Systems that facilitate the achievement of business objectives. This may involve:

Processing Customer Complaint records, including the escalation of urgent complaints.

Assisting in the processing of deviation investigations, CAPAs, and change controls.

Conducting initial impact assessments of Global change controls that may affect ExM Operations.

Participating in Virtual Plant Team (VPT) meetings as necessary.

Supporting risk assessment and mitigation strategies for Contract Manufacturing Organizations (CMO), as required.

Facilitating the tracking of CMO Health Authority inspection observations and CAPAs.

Escalating any emerging trends or issues to the VPTs as necessary.

Providing Quality input for ad hoc queries related to ExM Operations.

Metrics Collection and Processing Support:

Capture and report Quality data and metrics for management review and other organizational forums.

Utilize data analysis or software skills to enhance existing tools for improving quality system processes.

Collect statistical data and compile it for reports; update and ensure the accuracy of databases; create management reports; collect, compile, and analyze data and information.

Additional Duties:

Act as the team lead for coordinating 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.

Oversee the system and process for record management.

Maintain the system for updating ExM GxP (Good Practice) Authorizations.

Act as the ExM Quality Systems representative on ExM and Global Quality projects.

Support the scheduling, execution, reporting, follow-up, and tracking of self-inspection audits.

Assist in the preparation for and participation in Quality Council meetings.

Conduct self-inspection audits as part of the audit team.

Identify and implement continuous improvement opportunities for Quality Systems owned processes.

Serve as qualified training for Quality Systems owned processes.

Required Qualifications and Desired Experience:

A degree in a science-related field such as Chemistry, Engineering, or Biotechnology or equivalent.

A minimum of four (4) years of 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 participating in project teams.

Desirable:

Experience in a GxP Manufacturing environment.

Lead investigator training.

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