Manager, Quality Control

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Quality Control based in the United States.** This role leads quality control activities for critical clinical and regulatory documents supporting global drug development and submissions. You will oversee detailed reviews, copyediting, data verification, and proofreading to ensure documents meet rigorous scientific, regulatory, and internal standards. The position combines hands-on quality expertise with project coordination and people leadership within a global medical writing organization. You will work across complex documents including clinical study reports, protocols, investigator’s brochures, and regulatory submission materials. The role requires strong judgment and attention to detail while managing multiple projects, tight timelines, and evolving priorities. You will also help strengthen QC processes, templates, guidance, training, and consistency across the team. This is an opportunity to make a meaningful impact on the quality and readiness of documents used throughout clinical development and regulatory processes. ### Accountabilities - Oversee and coordinate assigned Quality Control reviews, ensuring clinical and regulatory documents are accurate, complete, consistent, compliant, and delivered within established timelines. - Review, copyedit, proofread, and verify data across clinical and regulatory documents, including Clinical Study Reports, protocols and amendments, Investigator’s Brochures, and clinical sections of INDs, NDAs, and MAAs. - Support QC review of manuscripts, abstracts, posters, briefing documents, health authority responses, narratives, and other documents requiring quality review. - Evaluate documents for content completeness, logical consistency, clarity, readability, formatting, and adherence to established templates and standards. - Identify missing information, inconsistencies, errors, and potential quality issues and collaborate with authors and stakeholders to resolve them before finalization. - Apply knowledge of pharmaceutical industry standards, regulatory requirements, internal procedures, and Global Medical Writing conventions to ensure document quality and compliance. - Manage QC timelines across multiple concurrent projects and communicate effectively with Medical Writers and other stakeholders regarding milestones, expectations, deliverables, and priorities. - Coordinate revision requests and review comments with document authors, helping drive efficient resolution and timely completion. - Work collaboratively with QC and Global Medical Writing leaders to support team direction, strategy, and consistent review practices. - Contribute to the development, maintenance, and continuous improvement of QC processes, templates, style guidance, workflows, and best practices. - Help identify opportunities for greater efficiency, consistency, and quality across medical writing and document review activities. - Serve as a subject-matter resource for complex editing, formatting, document quality, and regulatory-document questions. - Support onboarding, mentoring, and development of new QC team members and promote consistent quality standards across the team. - Participate in training, cross-functional learning, mentoring, and other development initiatives that strengthen technical editing and medical writing capabilities. - Provide direct leadership, coaching, performance management, and professional development support to assigned team members. - Set priorities and expectations for direct reports, provide ongoing feedback, and contribute to performance reviews and development planning. - Provide functional leadership and mentorship across the QC team and help build a collaborative, high-performing, quality-focused environment. - Oversee contractors, consultants, or other resources supporting QC activities when required. ## Requirements - Bachelor’s degree required; a Master’s, PhD, PharmD, or other graduate-level degree is preferred. - At least 5 years of relevant pharmaceutical or life sciences industry experience as a QC editor, QC specialist, medical writer, technical copyeditor, or similar professional. - Management experience is preferred, with demonstrated experience mentoring and developing team members and assessing the performance of direct reports. - Extensive experience reviewing or copyediting pharmaceutical regulatory documents, particularly Clinical Study Reports, clinical protocols, and protocol amendments. - Experience with clinical sections of INDs, NDAs, and MAAs is a strong advantage. - Thorough understanding of drug and biologics development processes and regulatory submission requirements, including FDA regulations and ICH guidelines. - Strong understanding of document quality principles, including content accuracy, consistency, completeness, readability, formatting, and adherence to templates and standards. - Experience developing and maintaining document templates, style guides, process documentation, and quality standards. - Excellent written and verbal English communication skills, with the ability to communicate complex issues clearly, concisely, and effectively. - Strong organizational and project management skills, with the ability to manage multiple projects, shifting priorities, and demanding timelines. - Exceptional attention to detail combined with the ability to understand broader strategic and departmental objectives. - Strong problem-solving and analytical skills, with the ability to identify issues, evaluate risks, and recommend practical solutions. - Demonstrated ability to provide constructive feedback, mentor colleagues, and support ongoing professional development. - Strategic mindset with the ability to connect QC practices and process improvements to broader medical writing and organizational objectives. - Comfortable embracing change, adopting new methods, and introducing innovative approaches to improve quality and efficiency. - Strong interpersonal and stakeholder management skills, with the ability to collaborate across functions and perspectives. - Proficiency with Microsoft Word, Adobe Acrobat, Microsoft Outlook, Excel, and PowerPoint. - Strong familiarity with Microsoft Windows and electronic document management systems. - Familiarity with SharePoint and Veeva Vault is preferred. ## Benefits - **Annual base salary:** $111,100–$151,100, with actual compensation determined by factors including job-related skills, depth of experience, certifications, relevant education or training, and specific work location. - Eligibility for an **annual bonus plan** for non-commercial roles. - Opportunity for **discretionary equity awards** and voluntary participation in an Employee Stock Purchase Plan. - Comprehensive **medical, dental, and vision insurance**. - **401(k)** retirement plan. - **FSA/HSA** options. - **Life insurance** coverage. - **Paid time off**. - **Wellness benefits**. - Remote work opportunity within the United States, with the role also compatible with global office environments. - Opportunity to lead and develop a QC team within a global medical writing organization. - Exposure to high-impact clinical and regulatory documentation supporting drug and biologics development. - Opportunity to shape QC processes, standards, training, and best practices across a growing organization.