Overview

Manages a team assigned to validate software. Responsible for establishing and maintaining continual improvement of systems that impact R&D and commercial operations of the organization. Collaborates with customers, business, and development teams to analyze business requirements to identify risk and ensure test cases are built to fully validate software.

Responsibilities

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

• Leads software validation efforts by implementing and managing projects; provides leadership and guidance to team members
• Selects and utilizes tools and methodologies to ensure that the quality of deliverables meets expected standards
• Maintains system documentation and process diagrams according to company standards and in compliance with regulatory requirements
• Works with process owners to understand the intent of software functionality of integrated business processes for the Blood Establishment Computer Software (BECS) system
• Provides technical training to team members, including but not limited to creating a logical breakdown of test cases based on risk assessment
• Develops comprehensive software validation protocols in alignment with the Agile framework used by Design and Development teams
• Designs and maintains script templates and discrepancy tracking logs; resolves discrepancies and writes validation summaries
• Coordinates with automated script development to create seed data and test run executions as well as manual regression and end-to-end test planning
• Oversees creation of validation script writing, execution and approval
• Creates and monitors reports for departmental key performance indicators, tracking and trending.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION AND/OR EXPERIENCE:

Bachelor’s degree from a four-year college or university and five (5) years blood banking experience, quality experience preferred; or equivalent combination of education, training and/or experience. A minimum of three (3) years of experience as a leader, managing high performing teams preferred.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

Medical Technology License, preferred

KNOWLEDGE, ABILITIES AND SKILLS:

• Knowledge of performing validation of BECS Software and Standard Operating Procedures
• Knowledge of risk/hazard analysis of business requirements leveraging GAMP 5
• Knowledge of FDA and international medical device regulations
• Knowledge in working with current issue and effect management software
• Knowledge and understanding of applicable Regulated Software Application (RSA) modules preferred
• Ability to think critically and prepare Seed Data required for use in executing Test Cases and associated Test Runs
• Ability to read, analyze, and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, governmental regulations
• Ability to write reports, correspondence, and procedure manuals according to CGMP (Current Good Manufacturing Practices) standards
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
• Ability to analyze and document complex business processes
• Ability to multitask and remain flexible when priorities or work direction change
• Strong analytical and problem-solving skills
• Ability to explain technical concepts in non-technical terms to customers and staff
• Knowledge in creating detailed test cases/scripts based on business and functional requirements, as well as reviewing the same
• Knowledge of software development life cycle principles and quality assurance methodology
• Ability to meet deadlines and focus on critical projects
• Ability to lead others to meet goals and objectives.

PHYSICAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Functions involve the ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds).

ENVIRONMENTAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.

Functions are regularly performed inside without potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances.