Job Description
We are seeking an IT PM for our US-based healthcare client. This is a great opportunity for someone to lead ERP recommendations, evaluation & selection in addition to system upgrades, and driving selection of new software platforms. This is a hybrid role and is expected to be a 6 month contract with an opportunity to convert to full-time based on performance.
- Collaborate with IT and Operations to streamline the business application portfolio.
- Establish standard operating procedures (SOPs) for application support and maintenance.
- Define business application requirements.
- Manage projects associated with business applications and solutions acrossfacilities
- Support the IT strategy through active leadership in application portfolio rationalization, software selection, and fiduciary discipline.
- Generate and maintain business application SOPs and perform required system administration and maintenance activities.
- Define, document, and implement support and administration standards for the client's applications and solutions.
- Lead the installation, maintenance, qualification, validation, and upgrade of new and existing business applications and solutions.
- Recommend acceptance of the computer system, as determined from validation performed on the protocol, and actions to be taken if the system is not accepted. Generate a final/validation report in accordance with actual FDA concepts.
- Assist in the development of validation documentation of computerized systems and support validation activities as per approved validation plans and protocols.
- Provide ongoing training to users on procedures, protocols, and computer systems.
- Perform project management functions for the requirements, design, development, and implementation of new solutions, upgrades, and/or replacement of business applications and solutions. Prioritize projects and schedules as needed.
- As required, provide Level II and III support for application issues reported to the Service Desk.
- Participate in, lead, or author investigations and root cause analysis exercises for the Information Technology department and company issues of non-compliance.
- Bachelor’s degree in computer science/Information Management preferred. A bachelor’s degree in a science or engineering related field (e.g. Chemistry, Biology or Electrical Engineering) with relevant experience may be considered.
- 7+ years of IT Project Management experience
- Proficient in Agile and Waterfall methodologies
- General knowledge of IT (servers, databases, applications, networking, workstations, operating systems, cloud services, etc)
- Knowledge and experience in Software Life Development Cycle (SLDC), GAMP5, and 21 CFR Part 11 regulations.
- Experience working in a highly regulated environment (FDA and manufacturing)
- ERP system knowledge – understanding and experience with ERP evaluations and implementations
- Ability to impact and influence people/areas within and outside company to deliver superior business results.
- Thorough knowledge of cGMP and FDA regulations with direct interaction during regulatory audits with agency staff.
- Excellent communication skills (oral, written and comprehension)
- Proven skills in project management and validation of manufacturing and quality related systems.
- Knowledge of Client Server environment, Windows 2008 and higher, SQL Server 2008 and higher, ERP systems, Quality systems, Lab systems, Analytics systems, etc.