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

Assist the Regulatory and Quality Compliance (RQC) team to ensure compliance with TraceLink procedures and relevant global regulations and standards (ISO 9001, FDA 21 CFR Part 11, EU Annex 11), and to ensure ISO certifications are maintained. Implement process improvements across the organization and collaborate with other functions to holistically create a culture of total quality and compliance. Improve quality management system processes, especially related to training, document management, records management, internal auditing, and KPI reporting.

Responsibilities

Ensure the company’s products and services organizations are compliant with relevant government and industry regulations including but not limited to: ISO 9001, US FDA 21 CFR Part 11, and EU Annex 11 for the development and maintenance of regulated software products and related servicesManage 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 practicesPerform internal quality audits of the organization, including authoring plans and reports, tracking findings, and follow upAssist with management of the QMS employee training program, compliance monitoring, eLMS system, and continual improvement effortsAssist with Corrective and Preventive Action (CAPA) investigations, root cause analysis, and authoring reportsMaintain metrics / Key Performance Indicators (KPIs) for operational effectiveness monitoring of key department functionsAssist with internal tool assurance activities including annual inventory reviews in collaboration with system business owners, periodic reviews, risk assessments, and performing tool validation/qualification where requiredInterface with RQC management, and all levels of functional management throughout the corporation to create, implement, improve, and monitor quality practices and procedures in accordance with corporate Quality Management System (QMS)Support software approval, release, and deployment activities, as needed and on a rotating basisStay abreast of industry and federal regulations and standards that inform the QMS including ISO 9001, Part 11/Annex 11, GAMP5, data integrity, and software validation/assuranceProvide input and guidance from a regulatory and quality perspective to functional areas of the corporation to facilitate decision making

Skills and Qualifications

Essential

BA/BS in engineering, computer science, information systems, or other scientific disciplineGeneral knowledge of the life sciences/healthcare/pharmaceutical industries, drug supply chain management, computer system validation, and/or medical devicesDemonstrated knowledge of ISO 9001 or similar standards4-6 years performing or managing quality, audit, and/or software validation/qualification activities within the pharmaceutical, medical device, clinical trial, or other related industryFamiliarity with cloud-based software, agile software development, and automation.Ability to work independently and as a team member in fast-paced environment, in an effective and flexible mannerHighly developed and proven written and verbal communication skillsStrong interpersonal skills to be able to build trust and relationships with cross-functional teams, challenge constructively, and collaborate and deliver results as a team.

Desirable

Experience with global teams across time zones and geographiesFamiliarity with US FDA 21 CFR 820/211, FDA Computer Software Assurance (CSA), GAMP5Experience with Medical Devices, Data Integrity, Data Privacy, Artificial Intelligence (AI)

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