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General Description:

The QMS Process Integration Expert as part of Quality Sciences and Knowledge Management will play a critical role in advancing global quality initiatives, ensuring the highest standards of product quality while fostering growth of BeOne’s QMS by incorporating emerging technologies and products. This position will build and continuously improve the knowledge management processes and tools to enable rapid access to data and knowledge over the entire product lifecycle.

This individual will guide project teams in effectively implementing QMS procedures and tools to streamline market entry. collaborate across functions and sites to drive process improvements and enhance the organization's approach to quality governance.

+ As SME for knowledge management (KM) provide expertise and guidance in all KM areas, including knowledge creation, knowledge catalog, governance for management of knowledge artifacts, knowledge management systems and/or platforms, and the user experience as it relates to their interaction with knowledge/content artifacts and technologies

+ Demonstrates technical expertise within functional responsibility area, staying up-to-date of new approaches & practices and building knowledge of emerging trends and advances within area. Integrate and maintain lesson learned-based processes within the knowledge management framework.

+ Develop or refine QMS-based procedures and tools to accomplish strategic portfolio-aligned objectives, regulations, industry best practices, and sound science. Within this scope, author and maintain necessary procedures in line with business needs.

+ Collaborate with R&D, manufacturing, and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management.

+ Adhere to project timelines and deliverables, lead cross-functional teams to develop and implement QMS improvements aligned with new-to-BeOne science and technology.

+ Develop a culture of planning, execution, and effectiveness assessment aligned with mid to late-stage pharmaceutical development.

+ Assist in the design and execution of global training programs to support knowledge transfer, technical expertise development and adoption of new quality technologies.

+ Contribute to product quality performance monitoring, identify trends and drive improvements.

+ Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices.

+ Perform other responsibilities as assigned.

Supervisory Responsibilities:

Managerial responsibilities for the team may include matrix reporting, oversight of contingent workers and or direct reports.

Computer Skills:

Familiarity with Microsoft Office suite of programs. Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc)

Skills and Qualifications:

+ Advanced degree in life sciences, quality management, or related field

+ 7+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).

+ Direct experience with QRM, QbD, Design Controls, and/or comparable quality best practices, regulations, and standards. (e.g., ICH Q9, ISO13455).

+ Expertise in quality systems, regulatory requirements (e.g., FDA, EMA), and risk management frameworks

+ Strong leadership and problem-solving skills, with the ability to manage complexity and ambiguity.

+ Ability to act as a quality, scientific, and process facilitation resource to product and process development teams.

+ Proficiency in quality tools and methodologies (e.g., root cause analysis, Lean, Six Sigma). Ability to communicate complex information clearly and effectively across business functions

Travel: Up to 20% internationally

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.