Full-Time

Associate Director

Digital Quality Management Systems Operations and User Experience

Posted on 11/1/2025

BeOne

BeOne

1,001-5,000 employees

Global oncology therapeutics discovery, development, manufacturing

Compensation Overview

$137.2k - $187.2k/yr

+

Remote in USA

Remote

Occasional travel up to 5% domestically/ internationally may be required.

Category
Operations & Logistics (8)
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Required Skills
Machine Learning
Requirements
  • Bachelor's degree in life sciences, computer sciences, quality management, or related field required
  • Minimum of 8+ years in Quality Assurance in a Pharmaceutical / Medical Device industry in a global environment
  • In-depth operational experience in at least one area of the GxP product life cycle
  • Advanced knowledge of US, EU, ICH and other GxP regulations
  • Experience in managing and operating digital quality applications (Veeva preferred)
  • Strong leadership, project management, and stakeholder management skills
  • Ability to communicate complex information clearly and effectively across business functions
  • Travel: Occasional travel domestic and international (up to 5%) may be required
Responsibilities
  • Oversee daily operations and business administration of digital QMS applications to ensure reliability, efficiency, and compliance
  • Monitor system performance and issue resolution, working closely with IT and vendors to minimize disruptions
  • Identify and implement process improvements to enhance system usability and operational efficiency
  • Develop and maintain a user support framework, including training materials, troubleshooting guides, and best practices
  • Act as the primary business point of contact for QMS users, ensuring timely resolution of system-related issues and questions
  • Gather user feedback to drive enhancements and optimizations in digital quality applications
  • Design and implement onboarding and training programs to enhance user adoption and competency with digital quality systems
  • Conduct user engagement initiatives, including webinars, workshops, and documentation to improve system utilization
  • Establish a knowledge base and self-service tools to promote efficient system usage
  • Ensure digital QMS applications remain compliant with regulatory requirements (e.g., US, EU, ICH GxP)
  • Work cross-functionally to implement AI-driven and automated solutions that improve system functionality
  • Partner with IT, Quality, and Business Process Owners to align digital QMS functionality with business needs
  • Support system upgrades, enhancements, and change management processes
  • Promote a culture of continuous improvement by identifying and implementing best practices
  • Assist in the development of digital QMS governance and strategy, ensuring alignment with business objectives
  • Perform other responsibilities as assigned
  • Supervisory Responsibilities: Ensure leadership, guidance and development opportunities for direct reports
Desired Qualifications
  • Advanced degree preferred

BeOne Medicines develops and commercializes cancer therapies for patients worldwide, focusing on hematologic cancers and solid tumors. Its products, including Brukinsa, are sold globally and supported by licensing partnerships, with internal R&D and clinical development driving a broad late-stage pipeline. BeOne differentiates itself by leveraging a large-scale clinical trial network and cost-efficient global drug development to achieve high margins while pursuing large-market indications. The company aims to expand into immunology and solid tumors while maintaining strong investment in R&D to make high-impact, accessible oncology treatments available in more than 45 countries.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Dongcheng District, China

Founded

2010

Simplify Jobs

Simplify's Take

What believers are saying

  • TEVIMBRA Priority Review and Breakthrough Designation for HER2+ gastric cancer expands addressable market.
  • Q1 2026 revenue of $1.5B exceeds forecasts; BRUKINSA sales grew 38% year-over-year.
  • First GAAP profitability achieved in 2025 with $942M free cash flow generation.

What critics are saying

  • AbbVie's ABBV-599 Phase 3 readout H2 2026 directly challenges BRUKINSA's CLL dominance.
  • Merck's pembrolizumab FDA label expansion blocks TEVIMBRA's gastric cancer approval pathway.
  • Dr. Reddy's ibrutinib generic captures 15% CLL market share with 25% price discounts.

What makes BeOne unique

  • BRUKINSA demonstrates 74% six-year PFS and 84% OS in frontline CLL versus competitors.
  • Only BTK inhibitor showing superiority versus ibrutinib in head-to-head clinical trials.
  • Advanced ADC platform with multispecific antibodies and proprietary payload chemistry for tumor targeting.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) Retirement Plan

Wellness Program

Paid Vacation

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

-2%

2 year growth

5%
Yahoo Finance
Apr 10th, 2026
Amgen's lung cancer drug tarlatamab wins China approval, seen as $2B+ opportunity

Amgen's lung cancer drug tarlatamab has received approval from China's National Medical Products Administration, according to its development partner BeOne Medicines. The drug is a targeted immunotherapy for adults with extensive-stage small cell lung cancer that has progressed despite chemotherapy. Sold as Imdelltra in the US, tarlatamab is a bispecific antibody designed to connect cancer cells with immune cells, enabling the body's immune system to destroy the cancer. Neither Amgen nor Hong Kong-listed BeOne provided details on launch date or pricing for the Chinese market. Wall Street analysts estimate tarlatamab could generate annual sales exceeding $2 billion for Amgen.

Yahoo Finance
Feb 26th, 2026
BeOne Medicines reports $1.5B revenue, up 33% despite EPS miss in Q4

BeOne Medicines reported $1.5 billion in revenue for the quarter ended December 2025, a 32.8% year-over-year increase, beating the Zacks Consensus Estimate by 3.19%. The company posted earnings per share of $0.58, compared to a loss of $1.43 in the prior year, though this fell short of the $1.60 consensus estimate. Net product revenues reached $1.48 billion, exceeding the $1.45 billion analyst estimate. BRUKINSA generated $1.15 billion, surpassing the $1.09 billion estimate, whilst TEVIMBRA contributed $182 million, slightly below the $191.33 million forecast. The stock has returned 0.6% over the past month, matching the S&P 500's performance. BeOne currently holds a Zacks Rank of 2, indicating potential outperformance.

Business Wire
Feb 26th, 2026
BeOne Medicines reports $5.3B full-year revenue as BRUKINSA sales surge 49%

BeOne Medicines reported fourth quarter 2025 product revenues of $1.5 billion and full-year revenues of $5.3 billion, representing growth of 32% and 40% year-over-year respectively. Product revenue accounted for 99% of total revenue. BRUKINSA, the company's BTK inhibitor, achieved global sales of $1.1 billion in Q4 and $3.9 billion for the full year, up 38% and 49% respectively. US sales reached $845 million in Q4 and $2.8 billion annually. TEVIMBRA generated $182 million in Q4 and $737 million for the year. The company reported GAAP net income of $67 million in Q4 and $287 million for the full year, compared to losses in prior-year periods. Free cash flow reached $942 million for 2025, up $1.6 billion year-over-year. BeOne provided 2026 guidance of $6.2–6.4 billion in total revenue and $1.4–1.5 billion in non-GAAP operating income.

Yahoo Finance
Feb 2nd, 2026
BeOne Medicines trades at $340 with 51% annual return amid undervaluation signals

BeOne Medicines is trading at $340.38, representing a 9.44% year-to-date gain and 51.29% total shareholder return over the past year, though recent performance has been mixed with a one-day decline and flat weekly performance. The company appears undervalued against an estimated fair value of $401.52, based on strong revenue growth fundamentals. BeOne reported 41% year-over-year revenue growth in Q2 and raised full-year guidance to $5–5.3 billion, driven by demand for its oncology therapy BRUKINSA. The valuation narrative assumes continued aggressive expansion and rising profitability, supported by an ageing population and increased global healthcare spending. However, risks include potential competition affecting BRUKINSA revenues and possible delays in late-stage trials or regulatory approvals.

TipRanks
Nov 20th, 2025
BeOne Medicines Secures $1 Billion Financing Agreement - TipRanks.com

BeOne Medicines ( ($ONC) ) has shared an announcement. On November 13, 2025, BeOne Medicines Ltd. entered into a Facilities Agreement with HSBC and other financial ...

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