Quality Assurance Manager

About the Role

Guerbet is seeking a qualified, dynamic QA Manager to enhance our quality management system through comprehensive SOP development, review, and revision. This role ensures compliance with FDA regulations (CFR), ISO standards, industry best practices, and all applicable legislative requirements for the company’s product portfolio. You will collaborate with cross-functional teams to provide quality and safety guidance, implement and maintain an audit and quality assurance system, and foster a positive progressive Quality culture.

Responsibilities

• Ensure good relations and communications with all team members and respond respectfully and promptly to internal and external customers.
• Interact influentially with staff to maintain and develop a positive Quality culture.
• Ensure compliance with FDA regulations (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 third-party contractors are legally approved and Technical Quality Agreements (TQA) are in place.
• Prepare and act as signatory in quality agreements (intercompany and external).
• Implement ISO 13485:2016 requirements for a quality management system to consistently meet customer and regulatory requirements.
• Ensure business compliance with cGxP requirements.
• Retrieve product traceability and ensure recall readiness.
• Attend and support regulatory body inspections (e.g., FDA, state agencies, or other health authorities) at Guerbet LLC.
• Ensure conformity of fully finished imported pharmaceutical products and release them for the US market.
• Oversee the Product Quality Review (PQR) system, review PQRs, and engage with relevant departments to address recommendations.
• Oversee the Customer Complaints system, facilitate investigations to establish root cause, and resolve complaints with cross-functional teams.
• Administer and monitor the QMS, including SOPs, quality management meetings, change controls, deviations, quality risk assessments, recalls, and audit reports.
• Facilitate follow-up meetings to discuss audit findings and agree on timelines for corrective action plans.
• Ensure updates and reviews of SOPs are documented and stored in a controlled system, complying with Global SOPs and regulatory standards.
• Cooperate with Training Responsible to ensure appropriate staff training.
• Provide quality support for Request For Quotation (RFQ) documents and processes.
• Supervise supply chain activities for Guerbet pharmaceuticals and medical devices performed by third-party logistics, ensuring compliance with local legislation.
• Ensure Guerbet products are supplied only to authorized or entitled persons through the customer qualification process.
• Implement tools to evaluate the quality of local processes and activities.
• Conduct/assist with internal self-inspection audits and complete response reports.
• Coordinate, evaluate, and follow up on CAPAs related to audit and inspection findings until implementation.
• Analyze audit findings, identify areas for improvement, and communicate trends to senior management.
• Maintain high-level awareness and expertise in international regulations to ensure appropriate regulatory surveillance.
• Perform other duties as assigned by management.

Requirements

• Minimum of 8 years of QA experience in the pharmaceutical/medical device industry.
• Advanced degree in a relevant field (Chemistry, Engineering, Life Sciences).
• Demonstrated expertise in FDA regulations and ISO standards.
• Experience with electronic quality management systems.
• Strong technical writing and process development skills.
• Previous consulting experience in SOP development.
• Proven experience in audit management and non-conformity resolution.
• Knowledge of document management/quality systems.
• Experience with FDA inspections.
• Knowledge of radiology environment (preferred).

Skills

• Excellent communication and project management skills.
• Ability to work independently and as part of a team.
• Strong interviewing and presentation skills.
• Effective communication and interpersonal skills.
• Excellent analytical, problem-solving, and decision-making skills.
• Attention to detail, initiative, confidentiality, and customer focus.
• Logical thinking, information-seeking, and sense of urgency.
• Supervisory skills.
• Excellent computer skills.