Quality Compliance Project Manager

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Job Summary:The Quality Compliance Project Manager will be responsible for the oversight and/or management of quality systems at all **MEMBERS ONLY**SIGN UP NOW***. (LCI) sites. Additionally, the Quality Compliance Specialist will be responsible for the administration of the Quality Management System (QMS) and Learning Management System (LMS).Responsibilities:• Work with cross-functional teams, including (but not limited to) site QA, Operations, Technical Services and Sales/Marketing, to develop strategies to remediate and/or prevent compliance risks;• Communicate project objectives, deliverables, timelines and tasks to team members• Communicate directly with individual sites to track and trend investigations, complaints and deviations as well as work with the sites to develop remediation plans/continuous improvement plans to maintain excellence in quality;• Acts as a subject matter expert (SME) on quality compliance in support of corporate and plant FDA inspections and sit in with FDA as necessary;• Act as a subject matter expert (SME) for the quality management and learning management systems• Maintains currency with current regulatory expectations associated with quality compliance;• Perform other corporate compliance activities as necessary.• Review and approve quality documents including change controls, PQCs and training• Communicate directly with individual sites to track and trend investigations, complaints and deviations as well as work with the sites to develop remediation plans/continuous improvement plans to maintain excellence in quality;• Ensure compliance to training programs for all Lannett sites;• Acts as a subject matter expert (SME) on quality compliance in support of corporate and plant FDA inspections and sit in with the FDA as necessary• Track and maintain Lannett field alerts reports (FAR) and recalls• Generate reports related to FARs and recalls for submission to the FDA• Work with cross-functional teams to develop strategies to remediate and/or prevent compliance risks;• Communicate project objectives, deliverables, timelines and tasks to team members• Manage the deficiency tracking system and gap analysis program to ensure that action items are completed on time to support timely approvals• Demonstrate leadership qualities while facilitating team meetings to ensure the agenda is followed; coordinate follow-up on action items• Promote continuous improvement of key business processes, including training other functional areas in project management processes and activities as necessary• Work with individuals across various departments to provide required compliance documents and reports to ensure compliance with regulations and procedures• Generate metrics to support quality systems and leadership meetings• Attend site and corporate quality meetings, as necessary• Act as a subject matter expert (SME) for the electronic quality management system;• Work with IT to aid in the administration of both QMS and LMS;• Work with business groups to maintain both QMS and LMS• Author, review, and train on SOPs• Author, review, and train on Best Practices/Work Instructions• Implement/evaluate systems and recommend changes/updates• Determine appropriate training modules for staff and ensure compliance Education and Experience Qualifications:• Minimum of six (6) years of quality systems experience in the Pharmaceutical Industry, or equivalent industry• Bachelor’s degree in Chemistry, Biology, Pharmacy, or related science• Experience with electronic quality management systems, electronic document management systems and/or electronic learning management systems• Leadership experience is a plus• Strong knowledge of FDA requirements related to quality compliance• Experience handling product quality complaints• Extensive experience in the reporting as well as managing of adverse event reports.• Experience in writing standard operating procedures, generating metrics and technical report writing• Experience interfacing with FDA or aiding in FDA interfacing

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