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

BeiGene, Ltd.

Job Overview

Location

Remote (US)

Job Type

Full-time

Full Job Description

📋 Description

• The Associate Director, Commercial Product Quality US Regional Lead, External Supply Quality at BeiGene, Ltd. is responsible for ensuring that externally manufactured commercial products meet regulatory and quality standards throughout their lifecycle, including manufacturing, packaging, labeling, storage, and transportation at Contract Manufacturing Organizations (CMOs). This role has global accountability for commercial product quality and supports product lifecycle management projects.
• Day-to-day responsibilities include leading a commercial product quality team, serving as the primary escalation point for CMO quality managers, reviewing and approving change controls and annual product quality review (APQR) reports, overseeing deviation investigations and CAPA implementation, managing inspection readiness for CMO-hosted and BeiGene-hosted inspections, ensuring timely batch release, supporting product recalls, and collaborating cross-functionally with Manufacturing, Supply Chain, Regulatory CMC, and Quality teams.
• BeiGene is a global biotechnology company dedicated to developing and commercializing innovative medicines to fight cancer. The company values scientific excellence, collaboration, and a patient-first mindset, offering professionals the opportunity to contribute to meaningful advancements in oncology while working in a dynamic, mission-driven environment.
• In this role, the individual will develop leadership expertise in global quality oversight, deepen knowledge of GMP/GDP regulations for both small and large molecules, strengthen cross-functional collaboration skills, and contribute to continuous improvement of quality systems. They will also gain experience managing budgets, mentoring teams, and driving compliance in a complex, international supply chain environment.

🎯 Requirements

• Bachelor of Science degree in a scientific or technical field (e.g., Pharmacy, Biology, Chemistry, Engineering) with 8+ years of quality pharmaceutical or biotechnology industry experience; Master’s degree and 6+ years of experience preferred
• 4+ years of management experience with responsibility for leading, developing, and coordinating a medium-sized team based in the US
• In-depth GMP experience in quality and manufacturing functions for both small molecule and large molecule products
• Strong PC literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
• Ability to apply logical and scientific thinking to solve complex problems and effectively lead teams
• Willingness to travel regionally and intercontinentally up to 30% of the time

🏖️ Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs
• Opportunity to own shares of BeiGene Medicines Ltd. stock through discretionary equity awards and participation in the Employee Stock Purchase Plan
• Eligibility for annual bonus or incentive compensation plans based on role classification
• Commitment to fair and equitable compensation with salary determined by skills, experience, education, and location
• Support for professional development and career growth through talent building and a culture focused on learning and initiative
• Equal opportunity employer with dedication to diversity, inclusion, and reasonable accommodation for protected individuals

Skills & Technologies

Senior

Remote

Degree Required

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BeiGene, Ltd.

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About BeiGene, Ltd.

BeiGene is a global biotechnology company discovering, developing, manufacturing and commercializing innovative oncology medicines. Its broad pipeline includes more than 50 clinical-stage molecules, spanning targeted therapy, immuno-oncology and combination regimens. Core products are BTK inhibitor BRUKINSA, PD-1 antibody tislelizumab and PARP inhibitor pamiparib, marketed worldwide through internal teams and strategic alliances. BeiGene operates integrated research campuses in Beijing and Cambridge, MA, a manufacturing facility in Suzhou and offices across North America, Europe and Asia-Pacific, serving patients in more than 45 countries.

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