Sr. Specialist - Computer Software Assurance Quality

Sr. Specialist - Computer Software Assurance Quality

Sr. Specialist - Computer Software Assurance Quality

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General Description

The Sr. Specialist, CSA Quality will serve as technical subject matter expert for Computer Software Assurance (CSA) process, including but not limited to GMP enterprise systems, manufacturing systems and computerized equipment, laboratory systems and computerized equipment and validation software tools. The role will also provide QA oversight for Computerized Systems and GMP IT Applications by supporting the ownership, review, and approval (as applicable) of QA records including SOPs, site deviations, CAPAs and change control records related to CSA equipment and GMP IT Applications. The role will work closely with manufacturing, QC, engineering, facilities to ensure compliance of cGMP systems with all internal Quality requirements. This role will be responsible for ensuring that our GxP systems meet regulatory requirements and internal quality standards, with a focus on risk-based, fit-for-purpose validation approaches in alignment with FDA and global regulatory expectations. This role is not limited to work also with related equipment associated with the computer systems and their Qualification or validation approach.

General Description

The Sr. Specialist, CSA Quality will serve as technical subject matter expert for Computer Software Assurance (CSA) process, including but not limited to GMP enterprise systems, manufacturing systems and computerized equipment, laboratory systems and computerized equipment and validation software tools. The role will also provide QA oversight for Computerized Systems and GMP IT Applications by supporting the ownership, review, and approval (as applicable) of QA records including SOPs, site deviations, CAPAs and change control records related to CSA equipment and GMP IT Applications. The role will work closely with manufacturing, QC, engineering, facilities to ensure compliance of cGMP systems with all internal Quality requirements. This role will be responsible for ensuring that our GxP systems meet regulatory requirements and internal quality standards, with a focus on risk-based, fit-for-purpose validation approaches in alignment with FDA and global regulatory expectations. This role is not limited to work also with related equipment associated with the computer systems and their Qualification or validation approach.

The successful candidate has excellent communication (written and verbal) skills, can thrive in a fast-paced environment, is quality-minded, detail oriented, and flexible in work schedule availability to meet the demands of a multi-product clinical and commercial phase cellular therapy company.

Principal Duties And Responsibilities

Review and approve all validation lifecycle documentation, including Validation Plans, User Requirements Specifications (URS), Functional / Design Specifications (FS / DS), Risk Assessments, Test Plans, Test Scripts, Traceability Matrices, Validation Summary Reports, and Periodic Review Reports.

Ensure all validation deliverables adhere to CSA best practices, with emphasis on risk-based testing strategies and streamlined documentation.

Serve as the Quality subject matter expert for CSA, providing guidance to business system owners, project teams, and QA on compliant, risk-based validation strategies.

Ensure adherence to FDA regulations (21 CFR Part 11, Part 210 / 211), GAMP 5, EU GMP Chapter 4, MHRA Guidance, ALCOA++, Audit Trails, and applicable ICH guidelines.

Review and approval of Data Integrity Assurance program deliverables (User Access Review, Audit Trail Review, Backup Review)

Work in Res_Q by Sware to manage the full validation lifecycle, ensuring accurate and complete documentation.

Oversight system Periodic Reviews, ensuring validated state is maintained and documented appropriately.

Approve test scripts, ensuring appropriate risk-based testing is applied, focusing on critical functionality.

Review and assess SaaS vendor validation packages for appropriateness, completeness, and alignment with internal requirements.

Job Description

DO NOT MODIFY THIS DOCUMENT WITHOUT PRIOR APPROVAL FROM HUMAN RESOURCES

Version 1.0 Last Updated on 3.10.2025

Ensure proper vendor assessments and documentation for cloud and SaaS solutions, ensuring alignment with GxP compliance expectations.

Collaborate with cross-functional teams (QA, IT, Business System Owners) to embed CSA processes into project lifecycles.

Participate in internal and external audits and inspections as a CSA subject matter expert. Plan, coordinate, and manage site-specific validation project activities including protocol development / approval, work schedules, and lifecycle documentation

Influences hiring, development, and related personnel processes

Mentoring and professional development of staff

Other duties as assigned

Knowledge, Skills, And Abilities Required

Bachelor's degree in computer science, Engineering, Life Sciences, or related field.

Minimum 8 years of experience in Computer Systems Validation (CSV), Computer Software Assurance (CSA), or Software Quality Assurance in a regulated (pharmaceutical / biotech preferred) environment.

Strong knowledge of FDA regulations, including 21 CFR Part 11, Annex 11, EU GMP Chapter 4, MHRA Guidance, ALCOA++, Audit Trails, and GAMP 5 principles.

Extensive experience authoring and reviewing validation documentation.

Experience implementing and maintaining risk-based validation approaches.

Strong technical knowledge of SaaS applications, cloud platforms, and infrastructure qualification principles.

Experience on the Risk assessment approach to support the CSA.

Familiarity with ITSM and Change Management processes (preferred in a GxP environment.)

Hands-on experience working in validation lifecycle management tools, with preference for experience in Res_Q by Sware.

Strong understanding of periodic review processes and maintaining the validated state.

Excellent communication and collaboration skills, with the ability to partner effectively across QA, IT, and business teams.

Project management experience a plus

Experience participating in regulatory inspections and audits as a validation SME.

Ability to manage multiple priorities in a fast-paced, evolving environment

Strong analytical and problem-solving skills.

Ability to apply critical thinking and risk-based decision-making to validation challenges.

Detail-oriented with strong documentation and organizational skills.

Ability to mentor and train cross-functional teams on CSA / CSV principles.

Experience with systems traditionally used in pharmaceutical manufacturing settings (LIMS, MES, QMS, ERP, etc.).

Familiarity with vendor audit and management processes for SaaS providers.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Sales, Business Development, and Management

Industries

Staffing and Recruiting

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