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BeOne Medicines logo
BeOne Medicines

Cancer has no borders. Neither do we.

Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge

RiskRiskOtherRemoteLeadTeam 10,001+Since 2010H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

131 days ago

Salary

$172K - $232K / year

Seniority

Lead

Bachelor Degree8 yrs expEnglish

Job Description

Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge

BeOne Medicines

• 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.

Job 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

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