Company overview:

TraceLink’s software solutions and Opus Platform help the pharmaceutical industry digitize their supply chain and enable greater compliance, visibility, and decision making. It reduces disruption to the supply of medicines to patients who need them, anywhere in the world.

 

Founded in 2009 with the simple mission of protecting patients, today Tracelink has 8 offices, over 800 employees and more than 1300 customers in over 60 countries around the world. Our expanding product suite continues to protect patients and now also enhances multi-enterprise collaboration through innovative new applications such as MINT.

 

Tracelink is recognized as an industry leader by Gartner and IDC, and for having a great company culture by Comparably.

Position Overview

In this role, you will act as a people manager within the RQC team, leading staff and providing strategy to ensure compliance with the TraceLink quality management system, relevant global regulations (e.g., ISO 9001, Part 11), and corporate policies regarding Software Development, IT, Customer Support and Service delivery for TraceLink’s SaaS applications and related products. Implement process improvements across the organization and collaborate with other functions to holistically create a culture of total quality and compliance. Report noncompliance issues and/or identified risks to TraceLink senior management and, where applicable, TraceLink information security.

Responsibilities

Provide strategy for growing and maintaining TraceLink’s Quality Management SystemCollaborate with Head of RQC to provide strategy for the RQC department, budget planning, and team developmentHire, manage, and develop personnel to meet demand and within budgeted guidelinesMaintain existing quality certifications (ISO 9001) and identify opportunities for additional certificationsMaintain, modify, and grow the corporate Quality Management System to comply with applicable industry standards and federal regulations (e.g., ISO 9001, 21 CFR Part 11, Annex 11, GxP, data integrity), to support continual improvements, and per corporate strategic goalsManage revision and approval of the Quality Management System (QMS) documents, including but not limited to periodic SOP reviews, change control, document management system (eQMS), control of records, electronic signatures, and good documentation practicesMonitor compliance to the Quality Management System and QMS-related global regulations for the company’s policies & procedures related to Software Development, Professional Services, Support, and IT organizationsLead/Perform internal quality audits of the organization, including authoring plans and reports, tracking findings and follow upPerform vendor qualifications per corporate policies and procedures regarding vendor oversight and reportingOversee QMS employee training program, compliance monitoring, eLMS system, and continual improvement effortsSupport Security department audits and certifications (ISO 27001, SOC2)Support the Corrective and Preventative Action (CAPA) program for tickets related to the above areasSupport hosting of customer audits and provide responses to customer audit reports for the above areasStay abreast of applicable industry standard and federal regulations, and provide guidance and expertise to the global organization in the areas of regulatory compliance and quality, with a primary focus on software in the life sciences industryProvide input and guidance from a regulatory and quality perspective across functional areas to facilitate decision-makingProvide support towards the improvement of quality system, training, and records management programs across the organization and all functions

Skills and Qualifications

Essential

10 + years of progressive quality experienceBE BTech/BS, MS Computer Sciences requiredAudit or Quality Certifications: ISO Certified Lead Auditor, Quality ManagementStrong knowledge of the pharmaceutical industry and SaaS technologyPrevious experience as a manager in pharmaceutical or technology quality assurance or compliance areasHighly developed and proven project management skills with an acute attention to detailsHighly developed and proven written and verbal communication skills

Desirable

Master’s Degree preferred but not requiredExperience with global teams across time zones and geographiesIn addition to pharmaceutical industry expertise: prefer experience with Medical Device, HIPAA, and/or Data PrivacyFamiliarity with US FDA 21 CFR 820/211, ICH Q9, Q10

Please see the Tracelink Privacy Policy for more information on how Tracelink processes your personal information during the recruitment process and, if applicable based on your location, how you can exercise your privacy rights. If you have questions about this privacy notice or need to contact us in connection with your personal data, including any requests to exercise your legal rights referred to at the end of this notice, please contact Candidate-Privacy@tracelink.com.