Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management
BeiGene
Unknown, Unknown
Full-Time
$172,000
HybridDirector
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The QMS Business Process Owner is responsible for managing assigned escalated GxP and Quality incidents in an end-to-end process on global level, initiating GxP/Quality incident prevention measures and maintaining (incl continuous improvement) of defined incident management related processes within regulated environments on global level. GxP (Good Practices) guidelines are critical for ensuring product quality, safety, and regulatory compliance in the pharmaceutical / life sciences sector. As BPO, the Director leads and oversees that quality incidents are managed effectively, root causes are identified, lessons learned are issued, and corrective and preventive actions (CAPAs) are developed to maintain the highest standards of compliance and patient safety and that the process operates for all BeOne operational groups.
As BPO for Quality Risk Management (QRM) frameworks, ensuring compliance with regulatory requirements (e.g., ICH Q9). Serve as a Subject Matter Expert (SME) and Facilitator for quality risk assessment, investigations, change control, and resolution of complex quality issues including review of regulatory CMC submission content.
Further, this position will build and grow the knowledge management processes and tools to enable rapid access to data and knowledge over the entire product lifecycle in collaboration with the Product Data Quality team.
This role requires a blend of technical expertise, leadership skills, and a proactive approach to quality and risk management as well as to continuous improvement.
Essential Functions of the Job:
Processes: Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on global level.
Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents in an end-to-end process, including resulting from deviations, regulatory and/or GxP non-conformances or other quality events.
Cross-Functional Collaboration: Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders to ensure timely and thorough management of GxP and quality incidents.
Root Cause Analysis and CAPA management: Drive and support comprehensive root cause investigations. Drive and oversee the development of corrective and preventive actions plans and lessons learned related to escalated GxP and Quality incidents. Drive initiation and execution of market actions, if required.
Regulatory and GxP Compliance: Ensure that the Escalation and Notification to Management related activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry (FDA, EMA, any local regulations, ISO, WHO); prepare for and support inspections and audits.
Training & Communication: Develop and deliver training on incident management procedures, share lessons learned from managed GxP/Quality incidents and promote a culture of quality and accountability across the organization.
Metrics & Reporting: Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.
Education and Experience Required:
Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
Master’s degree and 10+ years direct experience preferred
Supervisory Responsibilities:
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
Computer Skills:
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc)
Other Qualifications:
Experience with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics.
Travel: Up to 20%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.