Quality Compliance Manager

The Quality Assurance (QA) Department is an independent, neutral branch of TransPerfect. The goals of the department are simple: look out for the best interests of TransPerfect and its clients and promote and improve quality. The Quality Compliance Manager impacts all aspects of TransPerfect's Global Quality Management System (QMS), which is compliant to all applicable international and local statutory and regulatory requirements (e.g., 21 CFR Part 11 and GCP/ICH) as well as international standards such as ISO 9001 and ISO 17100. The CAPA Expert is a specialist in all formal client-facing reports related to non-conformances documented in Compliance Reports (CRs). They drive the CAPA process from start to finish with the goals of minimizing impact to operations for internal cost savings, ensuring consistency in reporting for clients, shortening report turnaround times (TATs), and decreasing the overall volume of CAPAs requested. The CAPA Expert owns, drives and oversees CAPAs from the time of request to client delivery and manages any post-delivery client feedback, driving continual improvement based on evolving needs.

• CAPA Report Management: Initial intake to determine if a CAPA Report is warranted and appropriate based on the severity of error and its impact
• Preflight of CAPA requests to survey the client relationship and type of report needed (NTF, NC, CAPA)
• Ensure all relevant CRs are properly documented in TransPerfect's Quality Management System (QMS)
• Create an internal schedule for CR investigation(s), approval(s), drafting, delivery
• Follow up to ensure everything is on track
• Write the CAPA Report based on the CRs
• Host and lead CAPA calls with all relevant parties to ensure content alignment
• Ensure QA compliance and avoid audit risks
• Deliver to the client-facing POC
• Maintain internal storage of CAPA Reports and associated documentation
• Handle responses to client feedback on CAPA Reports and deliver updated CAPA Reports, as needed
• Attend client calls as needed to present CAPA Reports
• Partner with the client's QA Department to ensure client satisfaction
• Track actions promised to clients in CAPA Reports and collect/validate objective evidence of completion
• Perform and oversee Effectiveness Checks to measure success of actions within scheduled timeframes, as needed
  • Additional Responsibilities: Supporting At-Risk Client initiatives including non-standard requests for trend analysis, Post-Mortems, Quality Improvement Plans (QIPs), Remediation Plans
  • Routine client-facing CR reporting outside of formal CAPAs (e.g., Excel format)
  • QA-to-QA client partnerships including routine meetings, reporting on Key Quality Indicators (KQIs), reviewing Quality Assurance Agreements (QAAs)
  • Client QBR Meeting support
    • Process Development: Manage CAPA Request Form improvements
    • Regularly assess workflow to ensure efficiency
    • Monitor initiation, tracking, and storage mechanisms
    • Take note of training gaps and partner with L&D to mitigate risks
    • Maintain CAPA related Bookstack reference content
    • Track CAPA data to identify trends
    • Decrease the overall volume of CAPA reports by educating client-facing POCs and promoting informal updates where appropriate
    • Complete all other tasks deemed appropriate for the role and assigned by the manager/supervisor
    Required Qualifications & Experience
    • Minimum Bachelor's degree or equivalent
    • Experience in complaint handling and due diligence
    • Fluency in English (written and verbal)
    • Excellent writing skills and knowledge of appropriate client language
    • Excellent organization skills and the ability to self-monitor and efficiently handle and prioritize tasks
    • Clear communication skills including delegation of tasks
    • Consistent positive and professional attitude and the desire to contribute to the CAPA culture
    • Natural leadership in calls/meetings
    • Exceptional problem solving and critical thinking
    • Deadline oriented
    • Desire to continually improve and the ability to take initiative independently
    Desired Experience
    • Trend/data analysis experience
    • Experience in root cause analysis methodologies

In order to apply, please submit your CV in English

• Associate

• Full-time

• Quality Assurance and Writing/Editing
• Industries: Translation and Localization