Global Compliance Partners
Principal Quality Engineer - IT
Global Compliance Partners, Oklahoma City, Oklahoma, United States
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Global Compliance Partners is seeking a highly motivated CSV/Quality Specialist to provide oversight and execution of critical quality functions across GxP computerized systems. The role requires a strong background in audit trail and periodic reviews, CAPA/Change Control/Deviation oversight, Data Integrity remediation, and SOP development for GMP readiness. The candidate will collaborate closely with internal teams, external vendors, and regulatory agencies to maintain compliance and ensure robust validation practices.
Overview
The CSV/Quality Specialist will lead and oversee quality systems related to GxP computerized systems, ensuring data integrity, regulatory readiness, and effective validation practices across the organization. Responsibilities
Audit Trail & Periodic Reviews : Lead execution and oversight of audit trail review programs and periodic reviews across GxP computerized systems. Quality Systems Oversight : Oversee and provide guidance on CAPAs, Change Controls, and Deviations to ensure timely closure and regulatory compliance. Data Integrity : Manage and oversee data integrity initiatives, remediation programs, and ensure alignment with regulatory expectations. SOP Development : Draft and implement SOPs to support GMP readiness in areas such as access control, admin support, CSV, IT, and data integrity functions. CSV Expertise : Apply extensive knowledge of Computer System Validation standards and industry guidance to interpret governing requirements and influence compliance strategies. Collaboration & Issue Resolution : Partner with internal stakeholders, vendors, and regulatory agencies to anticipate and resolve quality and compliance issues. Regulatory Knowledge : Apply in-depth knowledge of GxP computerized systems, validation principles, quality systems, and health authority expectations. Validation Planning : Perform SDLC validation planning to ensure complete end-to-end qualification of electronic systems. Site Validation Oversight : Provide oversight of the site validation master plan and ensure alignment across functions and entities. Training & Support : Train staff on QA implementation, execution of deliverables, and system workflows including Veeva. Qualifications
Bachelor’s or Master’s degree in Life Sciences, Computer Science, Engineering, or related discipline. Minimum 5+ years of experience in CSV, QA, or related GxP compliance functions. Strong understanding of FDA, EMA, ICH, ISPE, and GAMP 5 guidance. Hands-on experience in audit trail reviews, periodic reviews, and data integrity remediation. Proven track record in authoring and implementing SOPs for GMP readiness. Experience with Veeva or other eQMS platforms is preferred. Excellent written, verbal, and interpersonal communication skills. Ability to manage multiple projects, prioritize effectively, and deliver in fast-paced environments. Additional Details
Seniority level : Director Employment type : Contract Job function : Quality Assurance Referrals increase your chances of interviewing at Global Compliance Partners by 2x. Get notified about new Information Technology Engineer jobs in
Massachusetts, United States .
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The CSV/Quality Specialist will lead and oversee quality systems related to GxP computerized systems, ensuring data integrity, regulatory readiness, and effective validation practices across the organization. Responsibilities
Audit Trail & Periodic Reviews : Lead execution and oversight of audit trail review programs and periodic reviews across GxP computerized systems. Quality Systems Oversight : Oversee and provide guidance on CAPAs, Change Controls, and Deviations to ensure timely closure and regulatory compliance. Data Integrity : Manage and oversee data integrity initiatives, remediation programs, and ensure alignment with regulatory expectations. SOP Development : Draft and implement SOPs to support GMP readiness in areas such as access control, admin support, CSV, IT, and data integrity functions. CSV Expertise : Apply extensive knowledge of Computer System Validation standards and industry guidance to interpret governing requirements and influence compliance strategies. Collaboration & Issue Resolution : Partner with internal stakeholders, vendors, and regulatory agencies to anticipate and resolve quality and compliance issues. Regulatory Knowledge : Apply in-depth knowledge of GxP computerized systems, validation principles, quality systems, and health authority expectations. Validation Planning : Perform SDLC validation planning to ensure complete end-to-end qualification of electronic systems. Site Validation Oversight : Provide oversight of the site validation master plan and ensure alignment across functions and entities. Training & Support : Train staff on QA implementation, execution of deliverables, and system workflows including Veeva. Qualifications
Bachelor’s or Master’s degree in Life Sciences, Computer Science, Engineering, or related discipline. Minimum 5+ years of experience in CSV, QA, or related GxP compliance functions. Strong understanding of FDA, EMA, ICH, ISPE, and GAMP 5 guidance. Hands-on experience in audit trail reviews, periodic reviews, and data integrity remediation. Proven track record in authoring and implementing SOPs for GMP readiness. Experience with Veeva or other eQMS platforms is preferred. Excellent written, verbal, and interpersonal communication skills. Ability to manage multiple projects, prioritize effectively, and deliver in fast-paced environments. Additional Details
Seniority level : Director Employment type : Contract Job function : Quality Assurance Referrals increase your chances of interviewing at Global Compliance Partners by 2x. Get notified about new Information Technology Engineer jobs in
Massachusetts, United States .
#J-18808-Ljbffr