Director Regulatory Quality Compliance
Director Regulatory Quality Compliance
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Job Description
Company overview:
TraceLinks 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 multienterprise 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 TraceLinks 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 TraceLinks 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 QMSrelated global regulations for the companys 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 decisionmaking
- 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
- Masters 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
Please see the Tracelink Privacy Policyfor 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 .
Required Experience:
Director
Employment Type
Full Time
