Sr. Manager, Quality Assurance - United States
- The Sr. Manager, Quality Assurance position is responsible for the global management of the quality assurance document control function and reports to the Quality Assurance department head. It is a full-time position requiring in-depth knowledge and experience in the execution of document management processes, document QC, training documentation, and document change activities.
- The position requires an extremely high attention to detail, hands on experience managing document control processes and team, and past experience in QC review of regulatory submission documents.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Lead and coordinate the document control function to ensure version control, traceability/logging, and location/security of documents, including electronic (and paper, if applicable) archival/systems management.
- Manage logistics of the document change management program by preparing document change controls, coordinating change meetings, and ensuring proposed changes meet justification requirements.
- Manage the company’s controlled documents by ensuring that all documents are reviewed and revised in a timely manner. Assist with SOP writing, managing of reviews, and ensuring appropriate approvals.
- Maintain the company’s quality electronic document management system(s) by working with system vendor to ensure proper configuration, working with area managers on proper use and best practices, and training employees and consultants on use of the system.
- Manage document QC activities within QA to ensure accuracy of documents/data and internal consistency, including verification of data to approved source documents, for technical reports, product labeling, and regulatory submission documents.
- Work with other departments (e.g., Clinical Research, Medical Writing, Regulatory Affairs) on efforts to increase SOP/document quality and consistency across documents in specific programs and/or submissions.
- Manage document archiving according to the retention policy.
- Coordinate GXP training documentation and system tasks for new and existing employees, including management of the GXP training matrix.
- Manage document logistics during regulatory inspections (e.g., retrieval, logging, review, notifications, and inspection staff).
- Train and supervise any QA temporary staff/contractors.
- Other duties as assigned.
- At least 8 years of pharmaceutical industry experience.
- At least 7 years of document QC/review experience in a regulatory filing preparation setting using electronic submission system(s).
- At least 4 years of document management processes experience.
REQUIRED KNOWLEDGE AND ABILITIES:
- Advanced applied knowledge of the following:
- GXP electronic document control management processes and regulatory requirements is critical.
- Demonstrated analytical skills and extremely high attention to detail.
- Demonstrated strength in oral/written communication and interpersonal skills; team player
- Demonstrated organizational skills
- Experience in quality control and/or quality assurance of regulatory submissions / aggregate reports within the pharmaceutical industry is preferred.
Excellent skills in the following areas:
- Proven extensive technical writing experience, with the ability to provide work examples of such experience.
- Oral communication
- Interpersonal skills
- Team player
- Demonstrated in document management
- Advanced functional experience in the following computer applications:
- Microsoft Word
- Microsoft Excel
- eCTD application(s) and Sharepoint experience a plus.
- Electronic data management systems (e.g., Veeva Vault, MasterControl)