• Senior Compliance Specialist (CAPA experience needed)

    Job Locations US-MA-North Reading
    Posted Date 2 months ago(11/29/2018 9:20 AM)
    Job ID
  • ­

    Department Description

    The Regulatory and Quality Compliance (RQC) team is responsible for assuring that TraceLink products and services are compliant with relevant global regulations for the life sciences industry, including but not limited to GxP, 21 CFR Part 11, Annex 11, GAMP5, and TraceLink policies and standards. Our customers consider compliance with such industry regulations to be mandatory, and this is confirmed through frequent audits conducted by customers.


    Job Description

    Become a part of the RQC team to ensure compliance with the TraceLink quality management system, relevant global regulations, and TraceLink corporate policies regarding Development, IT, Customer Support and Service delivery. Implement process improvements across the organization and collaborate with other functions to holistically create a culture of total quality and compliance. Report non-compliance issues and/or identified risks to TraceLink senior management and, where applicable, TraceLink information security, legal/privacy, etc.



    Summary of Position

    • Responsible for ensuring the company’s products and services organizations are compliant with relevant government and industry regulations including but not limited to 21 CFR 11, Annex 11, GAMP5, and Guidance for Computer System Validation for the development of regulated software products and related services.
    • Manage the Corrective And Preventative Action (CAPA) program, and support the staff training program and the customer and prospective customer audit program, thereby fostering positive customer relations.
    • Interface with RQC management, and all levels of functional management throughout the organization to create, implement, improve, and monitor quality practices and procedures in accordance with the Quality Management System (QMS).
    • Inform senior management of any non-compliance incidents or regulatory compliance issues, which may arise internally or from external customers. 


    Primary Responsibilities

    • CAPA management; collaborate with department managers to address and manage CAPAs and Root Cause Analysis investigations to ensure customer satisfaction and process improvements. Provide CAPA metrics for senior management reporting.
    • Support scheduling, preparation, and hosting of customer audits and providing responses to audit reports, including follow-up to confirm completion of action items.
    • Support the staff training program across the organization including training assignments, procedure update refresher training, compliance reviews, and metrics reporting.
    • Stay abreast of relevant industry and federal regulations, and provide guidance and expertise to the global organization in the areas of regulatory compliance and quality.
    • Monitor compliance to the Quality Management System and relevant global regulations for the company’s Development, Professional Services, Support, and IT organizations.



    • Maintain, modify, and grow the Quality Management System to comply with industry standards and federal regulations (21 CFR 11, Annex 11, GAMP5, GxP, and TraceLink strategic goals).
    • Contribute to revisions and approvals of Quality Management System procedures.
    • Perform vendor qualifications with formal reports, enumerating any findings that may require corrective actions and follow up with vendors to ensure completion.
    • Perform internal quality audits across the organization based on the audit schedule, including quality system inspection and records inspection to confirm compliance, documented in formal audit reports enumerating any findings that may require corrective actions and follow up to ensure completion.
    • Provide input and guidance from a regulatory and quality perspective to functional areas of the organization to facilitate decision making related to product development/release, delivery of services, and customer relations.  


    Skills and Experience

    • General knowledge of the life sciences/ healthcare/ pharmaceutical industries, drug supply chain management, computer system validation, and/or medical devices.
    • 3-5 years preferred previous experience in regulatory compliance, software compliance, pharmaceutical quality assurance (QA), and/or pharmaceutical informatics.
    • Highly developed and proven record management skills with an acute attention to detail.
    • Highly developed and proven written and verbal communication skills.
    • Preferred Certifications: RAC, ISO Certified Auditor, Cloud Security Certification
    • Bachelor’s Degree in Computer Science, Scientific discipline, or equivalent; Master’s Degree preferred, but not required.


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