Associate Director, QMS Process Improvement and Analytics
BeiGene, Myrtle Point, Oregon, United States, 97458
Overview
Employer Industry: Biotechnology
Why consider this job opportunity:
Salary up to $189,900 annually
Eligible to participate in an annual bonus plan and an incentive compensation plan
Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs
Opportunity for career advancement and growth within the organization
Work in a collaborative environment focused on continuous improvement and digital transformation
Chance to make a meaningful impact in the fight against cancer
Responsibilities
Oversee and enhance the Quality Management System (QMS) processes to ensure compliance and efficiency
Collaborate with QMS Process Owners and teams to define and analyze key performance indicators (KPIs)
Support governance meetings by communicating risks, trends, and required actions regarding QMS processes
Lead cross-functional improvement projects to streamline QMS workflows and enhance user experience
Ensure audit readiness by maintaining complete and accessible QMS documentation and records
Qualifications (Required)
Bachelor’s degree and 8+ years of progressive quality leadership experience
5 years of managerial experience directly managing people or leading teams and projects
Strong knowledge of global regulatory requirements (FDA, EMA, ICH Q10, ISO 9001/13485)
Hands-on experience with QMS processes such as Deviation Management, Complaint Handling, and CAPA
Excellent technical writing, communication, and analytical skills
How to Stand Out (Preferred Qualifications)
Master’s degree with 6+ years of progressive quality leadership experience
Certification or training in Lean, Six Sigma, or similar process improvement methodology
Experience with electronic QMS systems and digital quality tools
Advanced user of Smartsheet for project tracking and collaboration
Proven ability to lead process improvement initiatives
#Biotechnology #QualityManagement #CareerOpportunity #CompetitivePay #ContinuousImprovement
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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Why consider this job opportunity:
Salary up to $189,900 annually
Eligible to participate in an annual bonus plan and an incentive compensation plan
Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs
Opportunity for career advancement and growth within the organization
Work in a collaborative environment focused on continuous improvement and digital transformation
Chance to make a meaningful impact in the fight against cancer
Responsibilities
Oversee and enhance the Quality Management System (QMS) processes to ensure compliance and efficiency
Collaborate with QMS Process Owners and teams to define and analyze key performance indicators (KPIs)
Support governance meetings by communicating risks, trends, and required actions regarding QMS processes
Lead cross-functional improvement projects to streamline QMS workflows and enhance user experience
Ensure audit readiness by maintaining complete and accessible QMS documentation and records
Qualifications (Required)
Bachelor’s degree and 8+ years of progressive quality leadership experience
5 years of managerial experience directly managing people or leading teams and projects
Strong knowledge of global regulatory requirements (FDA, EMA, ICH Q10, ISO 9001/13485)
Hands-on experience with QMS processes such as Deviation Management, Complaint Handling, and CAPA
Excellent technical writing, communication, and analytical skills
How to Stand Out (Preferred Qualifications)
Master’s degree with 6+ years of progressive quality leadership experience
Certification or training in Lean, Six Sigma, or similar process improvement methodology
Experience with electronic QMS systems and digital quality tools
Advanced user of Smartsheet for project tracking and collaboration
Proven ability to lead process improvement initiatives
#Biotechnology #QualityManagement #CareerOpportunity #CompetitivePay #ContinuousImprovement
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
#J-18808-Ljbffr