Sr Compliance Specialist job in Huntington
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||West Virginia (WV)|
The role of the Sr. Compliance Specialist is to provide expertise and guidance to the entire facility through maintaining Quality Assurance programs (i.e. management review, self-inspection program, external audit preparation, etc.) and compliance to regulations and established standards.|
1.Provides leadership in preparing the site for corporate and external audit readiness, including notified body audits and health authority inspections. Monitoring of audit follow-up activities. 2.Provides guidance to the facility in interpreting the regulations / guidelines (i.e. MDSAP requirements, ISO standards, etc.) and Novartis and Divisional procedures to ensure compliance. Support implementation of Regulatory, Novartis and Alcon Divisional Quality System requirements through gap assessment activities. 3.Champion continuous Quality System improvement and effectiveness. Maintain a detailed knowledge of the Medical Device regulations, guidance and requirements. Promote awareness of best industry practices, providing company training as required. 4.Supports completion of self-inspection audits per audit schedule and ensures that audits are documented in TrackWise. Additionally, works with CAPA owners to ensure adequate CAPA plan and implementation according to CAPA due dates. Performs CAPA verification / effectiveness reviews. 5.Supports investigation, preparation and communication of site escalations. 6.Collection, preparation, and presentation of compliance data and trend reports for Quality Management Reviews. Compilation of Quality Management Review minutes and final report, and oversight of follow-up activities. 7.Generation and collection of system metrics and measurements to support the ongoing maintenance of site compliance. Collaborate with Alcon Division Quality System and Compliance groups to ensure consistent metric reporting across Surgical business unit.
Maintain compliance with Regulatory, Novartis and Alcon Divisional Quality System requirements No critical/major findings from HA/NB/Novartis/Alcon audits Complete self-assessment schedule and assure audit CAPA effectiveness On-time completion of compliance objectives, including metric reporting and gap assessments.Bachelor's degree or 10 years of directly related experience. Minimum 2 years of related experience. Excellent written and verbal English. Preferred: 5 years applicable experience in Compliance, Medical Device QA or related field.