Software Quality Validation

We are seeking an experienced Software Quality Assurance professional to join our PharmBIO team. In this role, the associate will collaborate closely with both Information Technology and business teams to lead and support computer system validation efforts. They will ensure that software solutions are designed, developed, and maintained in alignment with good design practices, internal processes, and regulatory requirements. This individual will also work crossfunctionally to support validation activities associated with new products and processes.

This position will be located at our Elk Mills 2 facility in Elkton, Maryland, with the possibility of a hybrid work arrangement (one day remote per week).

Pay and Benefits:

• $143,000 - $171,000 per year
• Roles above $150k are eligible for the variable pay program each fiscal year, based on defined business performance metrics.
• Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills, and abilities.
• Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits. More details are available atwww.gore.com/careers/benefits

• Ensure that software/information systems used in the development and manufacture of products are developed, implemented, and maintained according to internal requirements and external regulations
• Provide subject matter expertise and training to cross-functional teams for computerized system validation.
• Ensure application of risk-based approach to software validation, including the development of testing strategies, defining test cases, and managing the testing process.
• Stay up to date on industry standards and best practices related to software validation and data integrity and proactively incorporate them into PharmBIO's quality system, as appropriate.
• Create, review and/or approve system change, configuration management, and supporting documentation activities.
• Contribute to process improvements by developing and updating written procedures related to computer systems validation.
• Serving as the PharmBIO liaison with other Gore IT teams to provide review and input of Enterprise-driven validation efforts and alignment with broader validation and data policies.
• Maintain compliance with training expectations as required for this position.
• Additional responsibilities as required within the scope of position.

• Bachelor's degree in information technology, engineering, or related technical or scientific field
• Minimum 5 years of experience in Software Quality Assurance, computer system validation
• Experience working within the FDA Quality System Regulation, 21 CFR Part 11, ISO 13485, ISO 15378, GAMP5 and/or the European and Canadian Medical Device Directives
• Experience creating system requirements and business process scenarios, assessing, mitigating, and controlling risk
• Experience creating and executing test cases, test scripts including mapping requirements to unit, integration and system tests
• Experience assessing and designing validation deliverables for a risk-based approach
• Demonstrated ability to work with global, cross-functional teams
• Demonstrated excellent written and oral communication skills, enabling other non-expert colleagues to understand and apply applicable practices and procedures
• Demonstrated ability to handle multiple projects and priorities with competing resources
• Demonstrated ability to work through ambiguity and challenges, have a process-oriented mindset, and desire for continual learning
• Ability to travel up to 5%

• Experience with risk management programs / processes and data protection policies
• Experience with enterprise platforms (ERP, MES), shop floor or laboratory instruments
• Experience working across on-premises and cloud-based architectures, including middleware/integration layers and multiple database technologies

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.