Quality and Regulatory Affairs Auditor - Sao Paulo

transperfect; São Paulo; In loco; BRL 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

TransPerfect's Quality Assurance (QA) Department ensures adherence to international standards and customer requirements through robust audits and continuous improvement.

The QA Auditor coordinates with clients, vendors and internal teams to drive compliant practices, CAPA actions and regulatory alignment across ISO 9001, ISO 17100 and ISO 27001 frameworks within Life Sciences. They help maintain accreditation, support inspections, and stay current with evolving global regulatory requirements.

Competenze

• Excellent written and verbal communication in English.
• Minimum Bachelor’s degree or its equivalent.
• Experience with ISO 9001, ISO 17100 (EN 15038) and/or ISO 27001 and/or other international standards and regulations.
• Previous experience overseeing sponsor audits, internal, and/or regulatory inspection audits
• Experience in Quality Assurance, CAPA, change control, deviation management, complaint handling, and regulatory compliance
• Minimum of two (2) years of experience in the Life Sciences industry, including experience with QA related audits, clinical study documentation, and eClinical technologies

Mansioni

• Develop and execute audit programs and schedules.
• Perform all auditing activities comply with relevant standards and regulations (ISO 9001, ISO 17100, GxP etc.).
• Host, manage and coordinate customer audits and qualification activities, including communications and outcomes
• Coordinate preparation for and hosting of customer audits, including allocation of internal resources
• Manage and resolve customer audit findings, corresponding action items, and follow-up assignments within required timeframes
• Build and maintain strong relationships with new and established client auditors, representatives and internal stakeholders
• Assist with RFI/RFP coordination and completion, as needed
• Conduct and support calls with customer auditors and quality representatives
• Co-host and/or support registrar and regulatory inspections or assist in closure activities, as required
• Conduct and support QA internal and independent ad-hoc audits, as needed
• Conduct and support TransPerfect’s non-linguistic supplier qualification, as needed
• Assist QA Management in creation, documentation, implementation, and evaluation of internal QA programs to maintain accreditation and certification
• Investigate audit findings, adverse experiences, and operational problems to identify root causes and implement effective corrective and preventive actions (CAPA), ensuring alignment with corporate processes
• Review effectiveness of CAPA resulting from customer, supplier, QA Internal or other related audits
• Utilize auditing platforms to analyze findings
• Maintain all internal trackers and technologies used in the QA audit processes
• Prepare and present periodic trend analysis reports to management
• Support management review by analyzing, collating and presenting QA audit data
• Consult project teams on resolution of audit findings, ensuring proper and timely audit resolution
• Contribute to continuous improvement and development of procedures to foster Total Quality Management (TQM) and enhance the Quality Management System (QMS), including technology enhancements
• Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies
• Stay current with regulatory and industry standards relevant to QA in regulated industries
• Handle additional duties and special projects to ensure efficient, effective, and compliant business operations
• Maintain audit integrity, ethical judgment and risk-based thinking in all audit practices
• Contribute to team efforts by accomplishing related results, as needed
• Travel domestically and internationally, as required
• Complete all other tasks that are deemed appropriate for the role and assigned by the manager/supervisor

Conoscenze

Excellent written and verbal comms in英

Bachelor's degree

ISO 9001

ISO 17100 EN15038

ISO 27001

QA audits

CAPA

Change control

Regulatory compliance

Life Sciences experience

Project management

Problem-solving

Independent work

Microsoft Office

Formazione

Bachelor's degree

Strumenti

Microsoft Office

Descrizione del lavoro

The Quality Assurance (QA) Department functions as an independent, objective division within TransPerfect, dedicated to advocating for the organization’s best interests through the promotion and continuous enhancement of quality standards.

The Quality Assurance Auditor exerts direct influence over all facets of TransPerfect’s Global Quality Management System (QMS), ensuring adherence to relevant international and local statutory and regulatory frameworks as well as compliance with globally recognized standards such as ISO 9001 and ISO 17100. The QA Auditor is integral to the development, implementation, and ongoing improvement of QA programs, policies, processes, and procedures.

Key responsibilities include ensuring customer satisfaction and retention by conducting compliance audits, facilitating remediation activities, and coordinating with clients, auditors, vendors, and other relevant stakeholders.

Position responsibilities

• Participate in the development and execution of audit programs and schedules
• Perform all auditing activities comply with relevant standards and regulations (ISO 9001, ISO 17100, GxP etc.)
• Host, manage and coordinate customer audits and qualification activities, including communications and outcomes
• Coordinate preparation for and hosting of customer audits, including allocation of internal resources
• Manage and resolve customer audit findings, corresponding action items, and follow-up assignments within required timeframes
• Build and maintain strong relationships with new and established client auditors, representatives and internal stakeholders
• Assist with RFI/RFP coordination and completion, as needed
• Conduct and support calls with customer auditors and quality representatives
• Co-host and/or support registrar and regulatory inspections or assist in closure activities, as required
• Conduct and support QA internal and independent ad-hoc audits, as needed
• Conduct and support TransPerfect’s non-linguistic supplier qualification, as needed
• Assist QA Management in creation, documentation, implementation, and evaluation of internal QA programs to maintain accreditation and certification
• Investigate audit findings, adverse experiences, and operational problems to identify root causes and implement effective corrective and preventive actions (CAPA), ensuring alignment with corporate processes
• Review effectiveness of CAPA resulting from customer, supplier, QA Internal or other related audits
• Utilize auditing platforms to analyze findings
• Maintain all internal trackers and technologies used in the QA audit processes
• Prepare and present periodic trend analysis reports to management
• Support management review by analyzing, collating and presenting QA audit data
• Consult project teams on resolution of audit findings, ensuring proper and timely audit resolution
• Contribute to continuous improvement and development of procedures to foster Total Quality Management (TQM) and enhance the Quality Management System (QMS), including technology enhancements
• Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies
• Stay current with regulatory and industry standards relevant to QA in regulated industries
• Handle additional duties and special projects to ensure efficient, effective, and compliant business operations
• Maintain audit integrity, ethical judgment and risk-based thinking in all audit practices
• Contribute to team efforts by accomplishing related results, as needed
• Travel domestically and internationally, as required
• Complete all other tasks that are deemed appropriate for the role and assigned by the manager/supervisor

Essential skills and experience required

• Excellent written and verbal communication skills in English
• Minimum Bachelor’s degree or its equivalent
• Experience with ISO 9001, ISO 17100 (EN 15038) and/or ISO 27001 and/or other international standards and regulations
• Previous experience overseeing sponsor audits, internal, and/or regulatory inspection audits
• Experience in Quality Assurance, CAPA, change control, deviation management, complaint handling, and regulatory compliance
• Minimum of two (2) years of experience in the Life Sciences industry, including experience with QA related audits, clinical study documentation, and eClinical technologies
• Proven ability to manage multiple projects and audits simultaneously in a fast-paced environment
• Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Ability to adhere to both customer and company quality standards and requirements
• Exceptional problem-solving and critical-thinking skills, with the ability to learn new skills quickly
• Ability to work independently and collaboratively in a team environment
• Proficiency in Microsoft Office suite

Desired skills and experience

• Experience with ISO 17100 (EN 15038) and/or ISO 27001 and/or other international standards and regulations
• Experience as QA in regulated industries (such as Finance, Healthcare, Pharmaceutical, CRO, Medical
• Device, Investigative Site, etc.)
• Experience with Six Sigma, Lean, and other quality standards
• Lead Auditor Certification in relevant ISO standards (ISO 9001, ISO27001, etc.)
• Fluency in a foreign language other than English is a plus
• Knowledge of clinical development phases and processes including ICH E6, 21 CFR Part 11 requirements, GxP;
• Experience in overseeing and training employees on QA SOPs and regulatory requirements
• Previous experience overseeing sponsor audits, internal, and/or hosting regulatory inspections