Manager, Quality Control

1. About Our Client:
The organization operates within the pharmaceutical and biotechnology sector, focusing on medical writing and regulatory document quality control. It addresses the critical challenge of ensuring clinical and regulatory documents meet stringent domestic and international standards for accuracy, clarity, and compliance. The organization supports the drug and biologics development process by providing high-quality document review and editing services that facilitate regulatory submissions worldwide. It has a global presence, offering remote and office-based work options.
2. About the Opportunity:
The Manager, Quality Control oversees the quality control review process for clinical and regulatory documents, ensuring these materials comply with regulatory standards and internal guidelines while meeting project deadlines. This role is pivotal in maintaining the scientific accuracy and consistency of documents that support regulatory submissions, thereby enabling the organization to uphold its standards and contribute to successful drug development and approval processes.
3. Responsibilities:
Coordinate and complete quality control reviews of clinical and regulatory documents, including study reports, protocols, brochures, and submission documents.
Ensure compliance with regulatory requirements and internal standards.
Collaborate with authors to resolve content gaps and inconsistencies.
Manage QC timelines and communicate expectations to medical writers.
Lead team strategy and provide direction within the QC group.
Support development and improvement of QC processes, templates, and guidance.
Participate in training and mentoring of QC team members.
Serve as a resource for complex editing and quality issues.
Manage staffing and performance of direct reports, including hiring, training, coaching, and evaluations.
4. Requirements:
Strong written and verbal communication skills in English.
Experience mentoring and managing team members.
Extensive experience in QC review or copyediting of pharmaceutical regulatory documents.
Understanding of drug/biologics development and regulatory submission requirements.
Experience with document templates, style guides, and process documentation.
Bachelor’s degree required; advanced degree preferred.
Minimum 5 years relevant industry experience; management experience preferred.
Proficiency in Microsoft Word, Adobe Acrobat, Outlook, Excel, PowerPoint, and familiarity with SharePoint and Veeva Vault preferred.
Ability to communicate clearly and escalate issues appropriately.
Ability to adapt to change and lead change initiatives.
Ability to innovate and adopt new methods.
5. Pay Range and Compensation Package:
The pay range and compensation package for this role will be determined based on the candidate’s experience, skills, and other relevant factors.
Equal Opportunity Statement: Our client is an equal opportunity employer. They celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, or national origin.
Note:
RemoteHunter is a recruitment partner of this role. Please note that all employment decisions, including candidate assessment, interviews, hiring, compensation, and employment terms, are made exclusively by the hiring employer.

Work arrangement
Yes