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Guerbet · 1 day ago

QA Manager

Princeton, NJ

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Guerbet is a global leader in medical imaging, dedicated to improving patient outcomes through innovative solutions. They are seeking a qualified QA Manager to enhance their quality management system, ensuring compliance with FDA regulations and ISO standards while working collaboratively with cross-functional teams.

Health CareMedicalPharmaceutical

Responsibilities

Ensure good relations and communications with all members of the team and responding respectfully and in a timely fashion to internal and external customers

Interact influentially with all members of staff to maintain and develop a positive progressive Quality culture throughout the organization

Perform other duties as assigned by management

Ensure compliance with the legislative requirements as set out by FDA (21 CFR 314, 21 CFR 820, 21 CFR 822) and PIC/S PE 011-1, as well as all applicable legislative requirements for the company’s product portfolio

Ensure that all third-party contractors are legally approved, and the applicable Technical Quality Agreements (TQA) are in place

Prepare and act as signatory in quality agreements (intercompany and external)

Ensure the implementation of ISO 13485:2016 requirements for a quality management system where the organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements

Ensure that the business complies with cGxP requirements

Be able to retrieve product traceability and ensure recall readiness

Responsible to attend and support regulatory body inspections (For example-FDA, state agencies or any other health authority) at Guerbet LLC level

Ensure of the conformity of fully finished imported pharmaceutical product and release for the US market

Perform the Product Quality Review system by reviewing PQRs and engaging with relevant departments to address recommendations and outstanding information

Oversee the Customer Complaints system and facilitate investigations to establish root cause and work with cross functional teams to facilitate the resolution of the customer complaints

Administration and monitor the QMS, including SOPs, quality management meetings, change controls, deviations, quality risk assessments, customer complaints, recalls, adulteration or counterfeiting investigations, periodic reviews, self-inspection and external audit reports

Facilitate follow-up meetings to discuss the audit findings, clarify questions, and agree on timelines for implementing of the corrective action plans

Ensure any updates and reviews of SOPs are documented and stored in a controlled system and ensure compliance with Global SOPs and with regulatory standards across various operations within the organization

Cooperate with Training Responsible to ensure the appropriate training of the staff

Provide quality support for assistance with Request For Quotation (RFQ) documents and processes

Supervise supply chain activities pertaining to Guerbet pharmaceuticals and medical devices performed by the third-party logistics. Ensure that these activities are performed in compliance with the local legislation and regulations

Ensure Guerbet products are only supplied to persons who are authorised or entitled to supply medicinal products to the public, through the customer qualification process

Implement all necessary tools to evaluate the quality of the local processes and activities

Conduct/assist with internal self-inspection audits and complete response report

Coordinate, evaluate and follow up on CAPAs related to audit and inspection findings until implementation of CAPA supported by acceptable evidence for critical and major findings

Analyze audit findings, identify areas for improvement and communicate trends to senior management

Maintain high level of awareness and expertise in international regulations so as to ensure appropriate regulatory surveillance

Qualification

FDA regulationsISO standardsQuality management systemsAudit managementProcess developmentElectronic quality managementTechnical writingAnalytical skillsSupervisory skillsComputer skillsCommunication skillsProject managementInterpersonal skillsProblem solving