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On-siteFull-timeMid levelQM
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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
In order to apply, please submit your CV in English