Associate Director, QMS Process Improvement and Analytics
BeiGene, Adah, Pennsylvania, United States
Employer Industry: Biotechnology
Why consider this job opportunity:
Salary up to $189,900 annually
Eligible for annual bonus plan and discretionary equity awards
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
Collaborative work environment focused on continuous improvement and digital transformation
Chance to contribute to meaningful projects aimed at fighting cancer
What to Expect (Job Responsibilities):
Oversee and improve BeOne’s Quality Management System (QMS) processes to align with quality and business objectives
Collaborate with teams to define, track, and analyze key performance indicators (KPIs) and recommend actions for process enhancement
Support governance meetings by communicating process performance, risks, trends, and required actions
Lead cross-functional improvement projects to streamline QMS workflows and enhance user experience
Ensure QMS documentation and records are complete and accessible for internal and external audits
What is Required (Qualifications):
Bachelor’s degree and 8+ years of progressive quality leadership experience required
5 years of managerial experience directly managing people or leading teams
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, and CAPA
Excellent technical writing and document review skills
How to Stand Out (Preferred Qualifications):
Master’s degree and 6+ years of progressive quality leadership experience
Certification or training in Lean, Six Sigma, or similar process improvement methodology
Experience with electronic QMS systems (e.g., Veeva, TrackWise) and data analytics
Proven ability to collaborate effectively in a cross‑functional, matrixed environment
Strong analytical and problem‑solving skills
#Biotechnology #QualityManagement #CareerOpportunity #CompetitivePay #ProcessImprovement
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 for annual bonus plan and discretionary equity awards
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
Collaborative work environment focused on continuous improvement and digital transformation
Chance to contribute to meaningful projects aimed at fighting cancer
What to Expect (Job Responsibilities):
Oversee and improve BeOne’s Quality Management System (QMS) processes to align with quality and business objectives
Collaborate with teams to define, track, and analyze key performance indicators (KPIs) and recommend actions for process enhancement
Support governance meetings by communicating process performance, risks, trends, and required actions
Lead cross-functional improvement projects to streamline QMS workflows and enhance user experience
Ensure QMS documentation and records are complete and accessible for internal and external audits
What is Required (Qualifications):
Bachelor’s degree and 8+ years of progressive quality leadership experience required
5 years of managerial experience directly managing people or leading teams
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, and CAPA
Excellent technical writing and document review skills
How to Stand Out (Preferred Qualifications):
Master’s degree and 6+ years of progressive quality leadership experience
Certification or training in Lean, Six Sigma, or similar process improvement methodology
Experience with electronic QMS systems (e.g., Veeva, TrackWise) and data analytics
Proven ability to collaborate effectively in a cross‑functional, matrixed environment
Strong analytical and problem‑solving skills
#Biotechnology #QualityManagement #CareerOpportunity #CompetitivePay #ProcessImprovement
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