Associate Director, Commercial Product Quality – External Supply Quality

🕒 July 1

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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

• Lead commercial product quality team to ensure the quality management process is in place and executed to ensure the product quality is compliant with regulatory requirements and BeOne standards. • Accountable for BeOne qualified CMO oversight within US including performance management, trend evaluations and remediation as required. • Serve as the primary escalation point for CMO quality managers. • Review and approve change control strategy for CMO notified changes. • Review and approve APQR reports from CMOs manufacturing BeOne product. • Lead batch related deviation handling in investigation and effective CAPA implementation at CMO. • Perform or oversee PIP (Person in Plant). • Oversee inspection management capabilities within the team to ensure successful outcomes for CMO hosted inspections or BeOne hosted inspections eg CMO PAIs, PV inspections. • Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changes. • Advise and support Quality Agreement content, implementation, and updates. • Work cross functionally and collaboratively in BeOne with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU. • Ensure quality support on product commercial supply e.g. timely batch release. • Support product recalls from commercial supply chain when needed. • Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines. • Work with cross functional partners to establish Process Performance Qualification for Small Molecule products. • Author Standard Operating Procedures related to function and department.

🎯 Requirements

• 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 • Master’s degree and 6+ years of experience preferred • 4+ years management experience • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) • In-depth GMP experience in a quality and manufacturing function for small molecule and large molecules.

🏖️ Benefits

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