Manage the activities of the Document Management and Control Department, which maintains GxP documents and develop and implement document management processes. Manage the development and implementation of GxP training programs at Argos to comply with global regulations and guidelines.
- Manage the daily activities of the Document System and Training Departments
- Oversee the document management systems at Argos, manage the accuracy and integrity of business documents throughout the document life cycle, process from conceptualization, review, approvals, distribution, through to filing.
- Establish and maintain documentation control systems.
- Provide technical and compliance expertise concerning document management to all areas of the company.
- Plan, develop, implement, and enforce document management policies for the company to support research, regulatory submissions, and manufacturing activities.
- Develop and enforce practices within the Document Management and Control Department to maintain a thorough and organized, centralized document management system, which will standardize filing, protecting, retrieving records, reports, and other information contained on paper, computer programs, or other media.
- Supervise the periodic review and provide status reports of approved documents to ensure compliance with internal procedures.
- Develop, implement, and monitor training program within Argos.
- Establish training curriculums with department managers and conduct periodic reviews of curriculums to ensure accuracy of assigned training requirements.
- Develop new training programs to comply with GXP regulations and guidelines
- Create brochures and training materials.
- Develop multimedia visual aids and presentations.
- Create testing and evaluation processes.
- Evaluate needs of company and plan training programs accordingly.
- Provide opportunities at Argos for classroom training, demonstrations, on-the-job training, meetings, conferences, and workshops.
- Build solid cross-functional relationships.
- Perform general management activities for the department, such as establishing and monitoring departmental goals, employee mentoring and performance evaluations
- Participate in internal and external audits of the facility by providing documentation and consultation as needed.
- Assist Department staff with daily activities and special projects as needed.
- Perform other related activities as required.
- Bachelor’s degree with 10+ years related experience in pharmaceutical/biopharmaceutical industry, which includes document management and training experience, or equivalent combination of education and experience
- Demonstrated strong communication skills, both written and verbal
- Ability to deal with problems involving several concrete variables in standardized solutions: ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Demonstrated ability to provide leadership and supervision to staff members.
- Ability and desire to respond professionally to common and/or sensitive inquiries or complaints from internal/external customers or regulatory agencies
- Strong public speaking skills for giving presentations and training groups of employees
- Knowledge of regulations governing documentation and training programs
- Strong, effective organizational skills required; detail oriented; ability to multi-task
- Demonstrated, effective leadership abilities required
- Must be able to successfully work across functional areas and interface with area management
- Computer literate with experience in Microsoft Office, SharePoint, Visio, and Adobe Acrobat
- Proficient grammar skills which reflect a strong aptitude for reviewing documents from a grammatical perspective
- Ability and willingness to be regularly, predictably and reliably at work