Quality Control Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $111.1k - $151.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 1%

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

• Oversee, coordinate, and complete assigned quality-control reviews of clinical and regulatory documents • Review, copyedit, verify data, and proofread documents for regulatory and internal standards • Ensure document quality, scientific accuracy, completeness, logical consistency, clarity, readability, and compliance • Identify gaps, inconsistencies, and missing information and collaborate with authors to resolve issues • Manage team direction and strategy with QC and Global Medical Writing leaders • Manage QC timelines and communicate expectations, milestones, and deliverables to Medical Writers • Prioritize multiple concurrent projects and deliver high-quality documents under tight timelines • Partner with authors and stakeholders to resolve revision requests and review comments • Develop, maintain, and improve QC processes, templates, guidance documents, and best practices • Support onboarding and mentor new QC team members • Serve as a resource for complex editing, formatting, and quality issues • Manage and supervise staffing and performance management, including hiring, training, coaching, and performance reviews for direct reports, if applicable

🎯 Requirements

• Clear, concise, and effective English communication skills, written and verbal • Experience directly mentoring and managing other team members • Management-related training modules or hands-on management experience • Proven desire to take on management-level responsibilities • Experience developing team members and assessing the performance of at least one direct report • Extensive experience conducting QC review or copyediting of pharmaceutical industry regulatory documents • Experience with clinical study reports, protocols, and protocol amendments • Experience reviewing or copyediting clinical sections of INDs, MAAs, and NDAs is a plus • Thorough understanding of drug/biologics development processes • Knowledge of FDA regulations and ICH guidelines for regulatory submissions • Experience developing and maintaining document templates, style guidance, and process documentation • BA/BS degree required • At least 5+ years of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor • Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems • Proficiency in Microsoft Outlook, Excel, PowerPoint, and Microsoft Windows • Proficiency or familiarity with SharePoint and Veeva Vault is preferred

🏖️ Benefits

• Annual bonus plan for non-commercial roles • Incentive compensation plan for 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 benefits • Remote work or work from any BeOne global office