Associate Director, QMS Process Improvement and Analytics
BeOne Medicines
full-time
Posted on:
Location Type: Hybrid
Location: Basel • Switzerland
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Job Level
About the role
- Support the implementation and maintenance of efficient, effective, and compliant QMS processes that align with BeOne’s quality and business objectives
- Collaborate with the QMS Process Oversight and Performance Management team and BPOs to define, track, and analyze key performance indicators (KPIs), identify trends, and recommend actions to enhance process performance
- Support Quality Council, Management Review, and other governance meetings by ensuring KPIs, clear summaries of process performance, and effective communication of risks, trends, and required actions
- Contribute to digital transformation initiatives by supporting the implementation of tools, automation, and analytics that modernize QMS processes and improve data visibility and system performance
- Collaborate with process owners and governance teams to review and enhance QMS policies and enterprise SOPs, ensuring clarity, consistency, and compliance with regulatory expectations
- Partner with functional teams to improve the technical accuracy and clarity of documentation within Deviations, Complaints, Change Controls, and other QMS records
- Lead or contribute to cross-functional improvement projects to streamline QMS workflows, enhance user experience, and improve right-first-time execution of quality records
- Support internal and external audit and inspection readiness by ensuring QMS documentation and records are complete, current, and easily accessible
- Work cross-functionally with Quality, Technical Operations, Regulatory, and other business partners to promote alignment and continuous improvement across QMS processes
Requirements
- Bachelor’s degree and 8+ years of progressive quality leadership experience required
- Master’s degree and 6+ years of progressive quality leadership experience preferred
- 5 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 electronic QMS systems (e.g., Veeva, TrackWise) and understanding of digital quality tools and data analytics
- Advanced user of Smartsheet for project tracking, reporting, and collaboration
- 8+ years of experience in Quality Systems or Quality Operations within a regulated industry (pharmaceutical, biotechnology, or medical device)
- Strong working knowledge of global regulatory requirements (FDA, EMA, ICH Q10, ISO 9001/13485)
- Hands-on experience with QMS processes such as Deviation Management, Complaint Handling, Change Control, CAPA, Training, Document Management, GxP Surveillance, and Management Review
- Demonstrated ability to lead or support process improvement and system enhancement initiatives
- Excellent technical writing and document review skills
- Strong analytical, problem-solving, and communication skills
- Proven ability to collaborate effectively in a cross-functional, matrixed environment
- Certification or training in Lean, Six Sigma, or similar process improvement methodology is a plus.
Benefits
- Competitive salary
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
QMS processesKPI analysisdigital transformationdata analyticsDeviation ManagementComplaint HandlingChange ControlCAPADocument ManagementGxP Surveillance
Soft Skills
leadershipcommunicationanalytical skillsproblem-solvingcollaborationtechnical writingproject managementprocess improvement
Certifications
LeanSix Sigma