Quality Control Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise, coordinate, and accomplish assigned quality-control evaluations of clinical and regulatory documents.

• Examine, copyedit, validate data, and proofread documents to meet regulatory and internal standards.

• Guarantee document quality, scientific accuracy, completeness, logical consistency, clarity, readability, and compliance.

• Detect gaps, inconsistencies, and missing information, collaborating with authors to address issues.

• Direct team strategy and guidance alongside QC and Global Medical Writing leaders.

• Oversee QC timelines and communicate expectations, milestones, and deliverables to Medical Writers.

• Manage multiple concurrent projects while delivering high-quality documents within tight deadlines.

• Collaborate with authors and stakeholders to address revision requests and review comments.

• Create, sustain, and enhance QC processes, templates, guidance documents, and best practices.

• Assist in onboarding and mentoring new QC team members.

• Act as a resource for complex editing, formatting, and quality-related issues.

• Oversee staffing and performance management, including hiring, training, coaching, and performance evaluations for direct reports, if applicable.

⛳️ Requirements

• Strong, concise, and effective communication skills in English, both written and verbal.

• Experience in directly mentoring and managing team members.

• Completion of management-related training modules or hands-on management experience.

• Demonstrated willingness to take on responsibilities at the management level.

• Experience in developing team members and evaluating the performance of at least one direct report.

• Extensive experience in conducting QC reviews or copyediting regulatory documents in the pharmaceutical industry.

• Familiarity with clinical study reports, protocols, and protocol amendments.

• Experience in reviewing or copyediting clinical sections of INDs, MAAs, and NDAs is advantageous.

• Comprehensive understanding of drug and biologics development processes.

• Knowledge of FDA regulations and ICH guidelines regarding regulatory submissions.

• Experience in developing and maintaining document templates, style guidelines, and process documentation.

• BA/BS degree is required.

• Minimum of 5+ years of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor.

• Technical proficiency in Microsoft Word, Adobe Acrobat, and electronic document management systems.

• Proficiency in Microsoft Outlook, Excel, PowerPoint, and Microsoft Windows.

• 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 options or the ability to work from any BeOne global office.