Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management
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.
- Ensure that the Escalation and Notification to Management related activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry (FDA, EMA, any local regulations, ISO, WHO); prepare for and support inspections and audits.
- Develop and deliver training on incident management procedures, share lessons learned from managed GxP/Quality incidents 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 (e.g., pharmaceuticals, biotechnology, medical devices)
- 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).
- Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc)
- 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 investigationregulatory compliancekey performance indicatorsincident documentationquality assurancequality controltraining developmentdata analysis
Soft Skills
leadershipcommunicationcollaborationproblem-solvingaccountabilityorganizational skillsstakeholder managementteam managementadaptabilityattention to detail