Position Summary:

Responsible for the over site of 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 tactical direction and immediate supervision to a group of employees by assigning tasks, checking work, and maintaining schedules.
• 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
• Drive engagement and creating a climate where staff are motivated to do their best.
• Ensures compliance with FDA, EMEA 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 support 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.
• Education: Bachelor’s degree in biological science or related field is preferred.
• Experience: Minimum 5 years experience in a GMP Environment; experience using EDMS required.

• Other Job Requirements:

• Competencies: Proficient in Word, Excel; Ability to utilize software and customized programs to meet business needs; Effective written and verbal communication skills; Good organization, planning, and time management skills.
• Physical Requirements: 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 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.
• Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment

• Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.