Quality Control Manager

Job Summary

Managing the oversight and completion of quality control reviews, the full-time Quality Control Manager will ensure the accuracy and compliance of clinical and regulatory documents while working remotely.

Key responsibilities:

• Oversee the QC review process for clinical and regulatory documents, ensuring adherence to industry standards and timelines
• Manage team direction and strategy, collaborating with stakeholders to address document revisions and maintain project timelines
• Engage in training and mentoring of QC team members to promote consistency and improve editing skills across the team

Required qualifications:

• BA/BS degree; advanced degrees such as Masters or PhD/PharmD are a plus
• At least 5+ years of relevant experience in QC editing, medical writing, or technical copyediting, with management experience preferred
• Extensive experience with pharmaceutical regulatory documents, including clinical study reports and INDs
• Thorough understanding of drug/biologics development processes and regulatory submission requirements
• Proficiency in Microsoft Word, Adobe Acrobat, and electronic document management systems