BeOne Medicines logo
BeOne Medicines

Cancer has no borders. Neither do we.

Associate Director, BPO Global APQR, Product Data Quality

DirectorDirectorFull TimeRemoteSeniorTeam 10,001+Since 2010H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

29 days ago

Salary

$143.4K - $193.4K / year

Seniority

Senior

Bachelor Degree6 yrs expEnglishTableau

Job Description

• 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. • Provides second line technical/scientific process support. • Supports cross-functional collaboration, drives process improvements and enhances the organization's approach to quality governance. • Collaborates across functions and sites to drive continuous improvement and ensure regulatory compliance. • 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.

Job 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
  • 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

  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness

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