Beigene

Beigene

Associate Director, Commercial Product Quality US Regional Lead, External Supply Quality

Remote (US) · Director

Sponsorship not specified$143k-$193kDetected 21 days ago
Data AnalysisExcelSupply ChainPerformance ManagementGMPProblem SolvingMicrosoft OfficeGxP

About the role

  • 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.
  • The role has global responsibility and accountability for commercial product quality for global supply.

Responsibilities

  • Build talent pipeline by inspiring and encouraging team members and create a great place to work for their personal development and career success.
  • Lead batch related deviation handling in investigation and effective CAPA implementation at CMO
  • Perform or oversee PIP (Person in Plant)
  • Advise and support Quality Agreement content, implementation, and updates.
  • Ensure quality support on product commercial supply e.g. timely batch release
  • Support product recalls from commercial supply chain when needed

Requirements

  • In-depth GMP experience in a quality and manufacturing function for small molecule and large molecules.
  • Bachelor of Science degree, in a related scientific discipline/technical field such as Pharmacy, Biology, Chemistry or Engineering 8+ years of quality pharmaceutical or biotechnology industry experience required
  • Ensures sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
  • Accountable for BeOne qualified CMO oversight within US including performance management, trend evaluations and remediation as required.
  • Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems Ability to effectively lead teams and manage staff

Nice to have

  • Master's degree and 6+ years of experience preferred

Skills

  • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

Compensation

  • $143,400.00 - $193,400.00 annually 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.
  • 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.

Benefits

  • Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changes

Company info

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity
  • 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.

Equal opportunity

  • We are proud to be an equal opportunity employer.
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This listing is sourced directly from Beigene's careers page and normalized into a canonical job model.