Associate Director, BPO Global APQR, Product Data Quality
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $143,400 - $193,400 per year
Job Level
About the role
- Owns the process which captures and examines BeOne’s product knowledge throughout the commercial lifecycle
- Maintains oversight on process capability through data trending and statistical analysis of critical variables
- Ensures process(es) are robust, in continued state of validation and continuously improving
- Ensures reliability and access to product information, process knowledge across functions via QMS systems
- Provides second line technical/scientific process support
- Supports cross-functional collaboration, drives process improvements, and enhances the organization's approach to quality governance using evidence backed decision making
- Collaborates across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge-sharing and risk management culture
- Contributes to product quality performance monitoring, identifying trends and driving improvements
- Collaborates with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management
- Manages change tracking and implementation for actions related to Regulatory CMC commitments
- Leads or participates in cross-functional teams to improve quality systems and address systemic challenges
- Represents the Quality Organization at platform level through participation in molecule level governance meetings and forums
- Supports regulatory inspections and audits, ensuring alignment with global quality standards and best practices
- Actively mentors new and existing team members to develop core Product Quality skills and leadership skills
- Performs other related responsibilities as assigned.
Requirements
- Bachelor’s degree and 6+ 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 8 + years' experience preferred
- 3 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)
- Advanced degree in life sciences, quality management, or related field
- Extensive experience in leading quality investigations, quality risk management, and implementing new technologies
- Expertise in quality systems, regulatory requirements (e.g., FDA, EMA), and risk management frameworks (e.g., ICH Q9)
- Strong leadership and problem-solving skills, with the ability to manage complexity and ambiguity
- Experience in developing and delivering global training programs ad fostering SME networks
- 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.
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality systemsquality risk managementroot cause analysisLeanSix Sigmadata trendingstatistical analysisregulatory requirementsquality investigationschange tracking
Soft Skills
leadershipproblem-solvingcross-functional collaborationmentoringcommunicationevidence backed decision makingprocess improvementorganizational skillscomplexity managementambiguity management