Director, Product Quality Lead

🕒 May 3

🇺🇸 United States – Remote

💵 $172k - $232k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 44%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Advance global quality initiatives and ensure high standards of product quality • Foster expertise in emerging quality technologies • Contribute to quality risk management, knowledge-sharing strategies, and technical training programs • Support cross-functional collaboration, drive process improvements, and enhance quality governance • Represent the Quality Organization in molecule-level governance meetings and forums • Serve as a Subject Matter Expert and facilitator for quality risk assessments, investigations, change control, and complex quality issues • Review regulatory CMC submission content • Manage Product Quality Network teams delivering for multiple late-phase clinical or commercial programs • Collaborate with R&D, manufacturing (CMC), and regulatory teams on product development and lifecycle management • Advise on CMC strategies and quality risk management for commercialization • Monitor product quality performance, identify trends, and drive improvements • Lead or participate in cross-functional teams improving quality systems and addressing systemic challenges • Support development and implementation of Quality Risk Management frameworks compliant with regulatory requirements such as ICH Q9 • Support regulatory inspections and audits • Mentor team members in Product Quality and leadership skills • Assess emerging scientific and technical trends and their implications for BeOne/BeiGene products • Perform other related responsibilities as assigned

🎯 Requirements

• Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry • 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources • Strong PC literacy • MS Office skills (Outlook, Word, Excel, PowerPoint) • Experience in statistical modeling software (Mintab, JMP, Tableau, SciLab) • 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) • Ability to communicate complex information clearly and effectively across business functions • Willingness to travel up to 20%

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness