Assoc Dir, cGxP IS- Sys/Network Admin Job in Mattapan 02126, Massachusetts Us
MAJOR RESPONSIBILITIES:
- Delivers cost effective, cGxP compliant IS solutions to meet clearly documented SME user needs. Maintains current industry knowledge and best practices.
- Manages the design, development, procurement and installation of internal data processing hardware and software operating systems, and telephone systems (PBX).Manages system performance (e.g. oversees testing and qualifications) and recommends hardware/software upgrades as necessary.
- May collaborate with Automation Engineering activities for the design, startup, validation, support, troubleshooting and ongoing operations of manufacturing, building management systems, RD and Quality Control.
- Recommends validation and qualification plans for software systems in accordance with cGxP. Ensures quality control through testing and debugging software for accuracy, completeness and system integrity. Develops procedures to assure the smooth transition of new systems and enhancements into operational status.
- Leads all electronic and paper documentation activity pertaining to Information Systems. Writes and / or approves cGxP documentation such as SOPs, change controls, incidents and deviations, planned deviations, and installation qualifications. Ensures documentation complies with cGxP and other applicable regulations. Creates and implements cGxP compliant documentation systems as necessary. Ensures that electronic records relating to cGxP activities are stored in secure cGxP / CFR compliant databases.
- Collaborates with Regulatory and Quality groups to ensure cGxP compliance.
- Manages server system administration. Directs, develops, implements, and maintains network security strategies and policies, including network rights administration. Ensures timely patch management and antivirus protection.
- Schedules, tracks, and reports projects. Manages projects effectively and proactively acts upon work assignments. Communicates regular updates on project status to end users and MBL Senior Leadership.
- Anticipates, prevents and prepares for IT related issues. Promptly resolves any IT related issues that arise. Responsible for data backup and disaster recovery. Directs, reviews, approves, and develops methods for local (stand alone desktop) system back up and disaster recovery systems in conjunction with the Help Desk group..
- Contributes to preparation of departmental budget and ensures adherence to departmental budget.
- Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance.
- Maintains effective communication and relationships internally and externally to MBL.
- Maintains up to date knowledge of industry trends and best practices.
- Providestechnical guidance to department personnel
- Performs additional job related duties as required.
MINIMUM QUALIFICATIONS:
- Requires a bachelor’s degree in Computer Systems, Engineering, or related field with a minimum 8 years of relevant experience or equivalent, including management experience
- Demonstrated ability to effectively manage others, conduct performance review process, set and prioritize departmental goals
- Excellent critical thinking, time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
- Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills.
- Adept understanding of applicable cGxP and Massachusetts Data Security regulations. Demonstrated ability to interpret and apply regulations to complex issues in order to manage risk
- Computer literate and proficient in MS Word, Excel and other relevant electronic systems
- Excellent critical thinking, time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
- Excellent written and verbal communication skills, with the ability to present at the highest level of the organization and work well with others internally (up, down, and laterally) and externally to the organization.
- Ability to engage, sustain, and influence effective relationships at the management level
- Advanced knowledge of Microsoft operating systems and applications, LAN, WLAN, WAN IP routing, network security, network management, process automation (SCADA, HMI's) and building management and building security systems is required
- Advanced knowledge of Electronic Document Management systems, Oracle Clinical, Oracle ERP, Computerized Maintenance Management systems, Sharepoint, and computerized asset management systems is required
- Knowledge of Cisco phone systems and Siemens phone systems is preferred
- Occasional travel may be required
- Ability to work flexible and, at times extended hours to meet the business needs of a 24/7/365 manufacturing operation
- Ability to routinely lift up to 50 lbs using proper lifting technique (monitors, servers, switches)
Must be able to carry out the essential functions of this position, with reasonable accommodation if disabled
SUPERVISION RECEIVED:
Reports to the Senior Director of Administration, cGxP IS or designee
SUPERVISION EXERCISED:
Supervises lower level personnel
ENVIRONMENTAL WORKING CONDITIONS:
Job may involve working with or near toxic or infectious materials. Employee will be required to follow MBL SOPs and procedures
Qualifications
The Associate Director, cGxP IS Systems/Network Administration is responsible for the management oversight of systems and network administration to support FDA regulated manufacturing operations and associated research and development activities. Ensures the functionality of internal information systems, including systems programming, applications programming, networks and computer operations including all required qualifications and validations The individual is responsible for delivering FDA compliance and excellent customer service in an uninterrupted 24-hour manufacturing environment within a prescribed budget. This is a performance based position where success is measured through the achievement of organizational and departmental goals.
Minimum Education: Unspecified