Regulatory Quality Compliance Specialist Senior
Regulatory Quality Compliance Specialist Senior
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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
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 companys 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 services
- 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
- Perform internal quality audits of the organization including authoring plans and reports tracking findings and follow up
- Assist with management of the QMS employee training program compliance monitoring eLMS system and continual improvement efforts
- Assist with Corrective and Preventive Action (CAPA) investigations root cause analysis and authoring reports
- Maintain metrics / Key Performance Indicators (KPIs) for operational effectiveness monitoring of key department functions
- Assist 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 required
- Interface 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 basis
- Stay 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/assurance
- Provide 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 discipline
- General knowledge of the life sciences/healthcare/pharmaceutical industries drug supply chain management computer system validation and/or medical devices
- Demonstrated knowledge of ISO 9001 or similar standards
- 46 years performing or managing quality audit and/or software validation/qualification activities within the pharmaceutical medical device clinical trial or other related industry
- Familiarity with cloudbased software agile software development and automation.
- Ability to work independently and as a team member in fastpaced environment in an effective and flexible manner
- Highly developed and proven written and verbal communication skills
- Strong interpersonal skills to be able to build trust and relationships with crossfunctional teams challenge constructively and collaborate and deliver results as a team.
Desirable
- Experience with global teams across time zones and geographies
- Familiarity with US FDA 21 CFR 820/211 FDA Computer Software Assurance (CSA) GAMP5
- Experience with Medical Devices Data Integrity Data Privacy Artificial Intelligence (AI)
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:
Unclear Seniority
Employment Type
Full Time
