Oversees all aspects of the documentation control system for the site. Also oversees the electronic quality systems utilized for deviations/investigations, change control, and electronic document management system (EDMS).
- Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
- Ensures compliance with FDA, EMA and other cGMP regulations, including customer requirements and international regulatory requirements.
- Oversees processing of documents through the EDMS system.
- Monitors status of periodic review for applicable documents for the site.
- Oversees controlled document issuance (e.g. batch records, high risk forms, etc.) and ensures that such documents are provided to internal customers per their requirements.
- Manages site record retention as well as maintaining QAD archive and its contents.
- Oversees system administration and training required for electronic quality systems.
- Oversees daily work of group maintaining workload balance and prioritizing site needs.
- Sets objectives and tasks for staff and regularly reviews staff progress in meeting objectives.
- Effectively communicates with peers and all other departments on site.
- Provides support to site Safety initiatives.
- Performs any other tasks as requested by Senior Management to support Quality oversight activities.
Provides tactical direction and immediate supervision to a group of employees by planning, assigning tasks, checking work, maintaining schedules, and leading change.
Provides direct supervision and may assist with the work as demands dictate. Will supervise 4-6 direct reports.
Minimum of an Associate’s degree is preferred. Proven relevant work experience will be considered in lieu of a degree.
Minimum 5 years experience in a GMP Environment.
Knowledge of document control is required.
Experience using EDMS is required.
Demonstrated leadership experience is required.
Equivalent combinations of education, training, and relevant work experience may be considered.
- Ability to drive functional, technical and operational excellence.
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
- Able to promote and drive change within the department.
- Ability to interact and collaborate effectively with all levels of management.
- Firm knowledge of GMP and GDP requirements.
- Proficient in Microsoft Word and Excel.
- Proficient in use and understanding of controlled documentation and data systems.
- Excellent organizational skills.
- Excellent interpersonal, analytical/problem solving and communication skills.
- Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.