Quality Assurance Manager

WHAT WE ARE LOOKING FOR

Guerbet is looking for a qualified, dynamic QA Manager to enhance our quality management system through comprehensive SOP development, review, and revision, ensuring compliance with FDA regulations including CFR (Code of Federal Regulations), ISO standards, industry best practices, as well as all applicable legislative requirements for the company’s product portfolio.

Working with cross-functional teams, you will have to be an excellent communicator and will be responsible for ensuring that all projects have the appropriate local quality and safety input and guidance.

Implementation and maintenance of an audit and quality assurance system at the local level aligned with the Policies of the Group.

YOUR ROLE

General

• 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.

Quality Assurance

• 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.

Inspection & audits

• 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

YOUR BACKGROUND

• 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)

Soft Skills/Qualifications

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