Executive Medical Director
BeOne Medicines
Google Cloud Platform
Quality Compliance Manager, GCP
Amgen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇯🇵 Japan
Visit company websiteJob Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- Assist in the implementation, monitoring, and continuous improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight
- Track, document, and implement quality initiatives ensuring procedures and processes meet regulatory requirements
- Contribute to collection, analysis, and reporting of quality metrics (KPIs, KQIs) to identify trends, risks, and improvement areas
- Provide hands-on support to ensure procedural compliance with GCP standards and other regulatory requirements across R&D
- Act as liaison between the Process Quality function and Global Networks to support collaboration and information exchange
- Provide quality oversight primarily for key target sites
- Perform focused readiness checks of clinical trials remote and onsite
- Perform risk assessments to support identification of sites for audits
- Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions
- Coordinate activities related to site/sponsor inspections and audits including preparation, conduct, close out and response generation
Requirements
- Doctorate degree OR Master’s degree and 2 years of Quality/Compliance/Process Management experience OR Bachelor’s degree and 4 years of Quality/Compliance/Process Management experience OR Associate’s degree and 8 years of Quality/Compliance/Process Management experience OR High school diploma / GED and 10 years of Quality/Compliance/Process Management experience
- 2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility (preferred)
- Solid understanding of SOP/Standards management and methods/technology used to drive knowledge management across a diverse R&D environment
- Thorough understanding of Clinical R&D activities and Global Regulations
- Strong analytical, critical thinking, and decision-making abilities
- Experience with process monitoring, including applying analytical methods and modern technology to enable signal detection and quality improvement
- Proven team player with ability to take direction, learn rapidly, make rapid decisions and communicate them promptly
- Excellent verbal and written communication skills and strong business writing abilities
- Capability to understand and articulate technical concepts and literature in spoken and written English
- Acts as a technical expert in GCP; strong attention to detail and proficiency in managing data and reports
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
- Total Rewards Plan with health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities
- Career development opportunities
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management System (QMS)Quality AssuranceGCP (Good Clinical Practice)Risk AssessmentData Quality IndicatorsQuality Metrics (KPIs, KQIs)SOP/Standards ManagementProcess MonitoringAnalytical MethodsQuality by Design
Soft skills
Analytical SkillsCritical ThinkingDecision-MakingTeam PlayerCommunication SkillsBusiness WritingAttention to DetailLearning AgilityCollaborationProblem-Solving
