Quality Systems Manager

JOB SUMMRY:

This position is a computer system engineer that possess the knowledge of software platforms focused primarily on salesforce and hosted system platforms. The position will ensure quality centric applications work in line with business expectations with the software vendors. This position will resolve technical workflow issues, update coding within the systems, evaluate new software systems for business needs, update current workflows or metadata to address needed information and implement new systems per FDA regulation requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Evaluate new software applications for business needs.

• Maintains user licensure, contracts and system upgrades via change control system.

• Evaluate software applications in a test environment with system owners to ensure meeting business requirements.

• Provide training of software workflows to employees.

• Update current workflows in systems as required for new information or simplify process in a timely manner.

• Build new programs in the trackwise application to meet business needs.

• Upgrade workflow processes in Blue Mountain, Trackwise, Einfotree, and Compliance Wire to meet regulatory requirements.

• Administers the day to day administrative needs of the systems.

• Maintains the procedures of system administrators and update as needed.

• Maintains the uptime of the system.

• Provides a roadmap of system versions.

• Direct user administration of the system.

• Manages the following:

• New releases and fixes via change controls.

• User Requirement Specifications

• Design Specifications

• IQ/OQ testing.

• Requirements Traceability Matrices

• Update and communicate design changes

• Collaborates with Validation with Software company on:

• System Description

• Validation Plan

• Data Migration Plan

• UAT

• Validation Summary Report

• Decomissioning Plans

• Periodic Reviews

• Demonstrated successful implementation of at least one similar or larger scale computer system.

• Demonstrated cost savings, process improvements or revenue enhancements for a hosted or salesforce platform system

• Worked with Track wise, Compliance Wire and Blue Mountain systems.

EDUCATION AND/OR EXPERIENCE:

• Degree in an IT related field

• Know Pharmaceutical Quality requirements as applies to a pharmaceutical regulatory environment

• Strong written and verbal communication skills

• Ability to work independently on self paced projects or in a team environment.

• 2-4 years of TWD experience including the experience: configuration, validation, implementation, and/or system administration.

• 2-4 years of CSV experience.

• Familiar with Trackwise and Blue Mountain application systems

KNOWLEDGE, SKILLS & ABILITIES:

Strong oral and written communication skills, good analytical ability and problem-solving skills. Critical thinking application, Attentiveness to details and deadlines with the ability to prioritize work effectively. Flexibility to operate, and self-driven to excel, in a fast-paced environment. Demonstrate ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a proven ability to shift thought processes quickly from one task to another.

Strong Microsoft skill set, to include documentation formatting, Adobe application and Signature workflow process.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

Office Environment

PAI is an Equal Opportunity Employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled.