Director, Regulatory & Quality Compliance

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 System
• Collaborate with Head of RQC to provide strategy for the RQC department, budget planning, and team development
• Hire, manage, and develop personnel to meet demand and within budgeted guidelines
• Maintain existing quality certifications (ISO 9001) and identify opportunities for additional certifications
• Maintain, 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 goals
• Manage 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 practices
• Monitor 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 organizations
• Lead/Perform internal quality audits of the organization, including authoring plans and reports, tracking findings and follow up
• Perform vendor qualifications per corporate policies and procedures regarding vendor oversight and reporting
• Oversee QMS employee training program, compliance monitoring, eLMS system, and continual improvement efforts
• Support Security department audits and certifications (ISO 27001, SOC2)
• Support the Corrective and Preventative Action (CAPA) program for tickets related to the above areas
• Support hosting of customer audits and provide responses to customer audit reports for the above areas
• Stay 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 industry
• Provide input and guidance from a regulatory and quality perspective across functional areas to facilitate decision-making
• Provide 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 experience
• BE BTech/BS, MS Computer Sciences required
• Audit or Quality Certifications: ISO Certified Lead Auditor, Quality Management
• Strong knowledge of the pharmaceutical industry and SaaS technology
• Previous experience as a manager in pharmaceutical or technology quality assurance or compliance areas
• Highly developed and proven project management skills with an acute attention to details
• Highly developed and proven written and verbal communication skills

Desirable

• Master’s Degree preferred but not required
• Experience with global teams across time zones and geographies
• In addition to pharmaceutical industry expertise: prefer experience with Medical Device, HIPAA, and/or Data Privacy
• Familiarity with US FDA 21 CFR 820/211, ICH Q9, Q10

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