BeOne Medicines

Associate Director, BPO, Global APQR, Product Data Quality

BeOne Medicines

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

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Job Level

Senior

Tech Stack

Tableau

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 and in a continued state of validation
  • Provides second line technical/scientific process support
  • Support cross-functional collaboration and drive process improvements
  • Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management
  • Manage change tracking and implementation for actions related to Regulatory CMC commitments
  • Lead or participate in cross-functional teams to improve quality systems and address systemic challenges
  • Represent the Quality Organization at platform level in molecule level governance meetings and forums
  • Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices
  • Actively mentor new and existing team members to develop core Product Quality skills and leadership skills

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)
  • Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc) and statistical modeling software (Mintab, JMP, Tableau, SciLab, etc)
  • 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 and fostering SME networks
  • Proficiency in quality tools and methodologies (e.g., root cause analysis, Lean, Six Sigma).
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
statistical analysisquality investigationsquality risk managementroot cause analysisLeanSix Sigmastatistical modeling softwarequality toolsregulatory requirementsquality systems
Soft Skills
leadershipproblem-solvingcross-functional collaborationmentoringcommunicationprocess improvementmanaging complexitymanaging ambiguityteam managementtraining program development