Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $172,000 - $232,000 per year
Job Level
About the role
- Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on global level.
- Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents in an end-to-end process.
- Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders to ensure timely and thorough management of GxP and quality incidents.
- Drive and support comprehensive root cause investigations and the development of corrective and preventive actions plans and lessons learned related to escalated GxP and Quality incidents.
- Ensure that the activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry; prepare for and support inspections and audits.
- Develop and deliver training on incident management procedures and promote a culture of quality and accountability across the organization.
- Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.
Requirements
- Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry
- Master’s degree and 10+ years direct experience preferred
- 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
- Experience with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics.
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GxPQuality incident managementRoot cause investigationCorrective and preventive actionsKey performance indicators (KPIs)Incident trends analysisDocumentation complianceTraining development
Soft Skills
LeadershipCollaborationCommunicationAccountabilityProblem-solving