Privacy Compliance Manager
Instructure
Cloud
Manager, Regulatory Compliance
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $115,400 - $155,400 per year
Job Level
Mid-LevelSenior
About the role
- Support the Global Regulatory Compliance Framework, strengthening inspection readiness and proactive risk oversight across Regulatory Affairs and Regulatory Operations
- Contribute to compliance governance, inspection management, and risk assessment activities, including audit/inspection logistics, root cause analysis, and development of risk reports
- Act as the first point of contact for reported compliance issues or discrepancies, performing initial assessments and proposing solutions before escalation
- Prepare compliance reporting packages and communicate findings, risks, and trends to senior leadership
- Develop, implement, and monitor Issues, Quality Events, CAPAs, and Deviation processes specific to Regulatory Affairs and Regulatory Operations, ensuring alignment with BeOne standards
- Facilitate investigations, author or review investigation reports, and organize cross-functional teams to develop corrective action plans
- Review and approve CAPA plans, track progress, escalate hazardous deviations, and provide timely updates to senior management
- Generate and issue regular deviation, CAPA, and risk management status reports; develop related training as needed
- Ideate and support the implementation of electronic workflows within Veeva RIM to automate regulatory processes, partnering closely with the Regulatory Technology team
- Ensure data integrity and compliance of regulatory information across systems, with emphasis on Veeva RIM
- Provide subject matter expertise on regulatory compliance processes, systems, and data integrity controls
- Monitor and analyze compliance health metrics, emerging risks, and regulatory trends
- Develop and maintain KPIs, trend reports, and dashboards to provide actionable insights to senior leadership
- Expedite communication of critical risks and deviations to senior management and recommend mitigations
- Partner cross-functionally with Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC, and other teams to identify compliance gaps and embed sustainable compliance controls
- Lead or support process improvement initiatives to enhance efficiency, standardization, and oversight
- Write, review, and approve SOPs, Risk Assessments, and related documents
- Develop and deliver training on compliance readiness processes
- Identify opportunities for streamlining work and improving efficiency, flexibility, and effectiveness
- Coordinate and manage multiple compliance activities and projects from initiation to closure
- Develop and maintain compliance training curricula specific to Regulatory Affairs and Regulatory Operations, ensuring alignment with global health authority requirements and BeOne standards
- Design and deliver targeted training on inspection readiness, issue management, deviation/CAPA management and other regulatory compliance processes
- Monitor training effectiveness and compliance through assessments, metrics, and feedback, implementing improvements to enhance knowledge retention and regulatory preparedness
Requirements
- Bachelor’s degree required with 5 + years of experience in regulatory compliance, regulatory operations, quality, or related GxP functions in the pharmaceutical/biotech industry
- Strong knowledge of health authority requirements, inspection trends (FDA, EMA, MHRA, Health Canada, PMDA, 21 CFR Part 11, ICH Guidelines , GxP Regulations), and ALCOA+ data integrity principles strongly desired
- Understanding of global regulatory requirements and data standards (e.g. IDMP, xEVMPD , eCTD)
- Demonstrated experience in compliance risk assessments, inspection readiness, root cause analysis, and regulatory data integrity oversight
- Technology Savvy with proven ability to analyze data and interpret into compliance metrics, dashboards and data analytics
- Strong communication skills with the ability to influence cross-functionally
- Experience leading or supporting process improvements and change management
- Ability to work independently, manage competing priorities, and deliver in a fast-paced environment
- Strong technical writing skills for regulatory and compliance documentation
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
regulatory complianceregulatory operationsquality managementrisk assessmentroot cause analysisCAPA managementdata integritycompliance metricstechnical writingGxP regulations
Soft skills
strong communicationinfluencing skillsindependent worktime managementprocess improvementchange managementcross-functional collaborationtraining developmentproblem-solvingorganizational skills
