Manager, Document Control
Responsible for the deliverables of the Quality Assurance documentation control group, including documents that support regulatory and submission needs, ensuring compliance with regulatory and quality regulations. Responsible for the administration and management of the electronic document management system (EDMS). Provide leadership and supervision of the documentation staff members.
- Manages the daily activities of documentation control group, prioritizing workflow.
- Manages administration of the EDMS; responsible for training EDMS administrators, evaluation and validation of new or upgraded EDMS systems, and company-wide training of employees on new EDMS systems.
- Ensure compliance with ISO 13485 and FDA 21 CFR 820 requirements are met by following GMP, accurate documentation, and reporting.
- Provides expertise in technical writing.
- Reviews and edits technical documents for appropriate content and presentation of data for compliance, as well as format, style, and language correctness, working directly with authors.
- Perform process-mapping for Document Control work and recommend areas for improvement
- Trains new employees in department and company procedures.
- Creates and maintains the document templates for Cerus documents.
- Reviews SOPs, instructions, methods, and other documents and mentors employees in becoming proficient in these document types.
- Works closely with authors and regulatory managers in the preparation of submission documents.
- Ensures budgeting, scheduling, staffing, performance management and training requirements are met.
- Manages in-house archiving of and oversees off-site storage of records.
- Performs other duties as required.
·Bachelor’s Degree with a minimum of 5 years’ experience in technical or medical writing, or document control.
- Previous management experience with demonstrated organizational and leadership skills; organize and direct workload; create and monitor employee goals; provide constructive feedback; conduct performance reviews; create, monitor, and report metrics to both team and management; conduct weekly team meetings; and assist in inspections and documentation control, as required.
- Experience with validation and implementation of EDMS systems.
- Experience in EDMS administration.
- Expert knowledge of Microsoft Word, Excel, and Adobe Acrobat.
- Excellent communication skills (encompasses verbal, written, interpersonal, listening).
- Ability to prioritize and meet stringent deadlines; attention to detail; strong team-building skills.
- Knowledge of the drug/device and quality management system documentation requirements.