SAP Principal IT Validation and Compliance

Overview

Location: Durham, NC (Regular on-site/Remote)

This individual will provide thought leadership, technical expertise, and management of managed validation services for SAP enterprise systems within the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) environment. The role is responsible for SAP validation review and approval of lifecycle deliverables, as well as technical oversight of SAP-related change controls, CAPAs, and deviations. Working closely with Quality Validation and SAP application teams, this individual provides strategic and technical expertise for all global SAP validation matters, ensuring compliance with cGMPs, regulatory requirements, and internal KBI standards.

• Provide global oversight for SAP system validation across all SAP modules (e.g. SAP S/4
  
  HANA, MM (IM), EWM, QM, PP, GRC, and Solution Manager, etc.) and support integrations.
• Lead validation direction and approval of SAP lifecycle deliverables including URS, FRS/FS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ, CSV Plans, Validation Summaries, and Release Documentation.
• Manage and provide oversight of managed validation services for SAP implementation, upgrade, and enhancement projects.
• Provide SAP validation review and approval for SAP-related change controls, CAPAs, and deviations, ensuring all impacts are properly assessed, documented, and resolved.
• Support SAP data integrity initiatives, including validation and compliance of SAP controls, audit trails, electronic signatures, segregation of duties (SoD), access controls, and data lifecycle governance.
• Provide SAP compliance expertise and input for global Policies, SOPs, and Templates for SAP enterprise systems.
• Serve as a key SAP validation SME supporting audits, regulatory inspections, and internal quality reviews.

• 15+ years experience in a cGMP environment in computer system validation with demonstrated career growth and achievements.
• Direct SAP validation experience in an FDA-regulated manufacturing or CDMO environment.
• Strong working knowledge of SAP lifecycle validation (implementation, upgrade, change control, and periodic review).
• Expert understanding of 21 CFR Part 11, EU Annex 11, and regulatory guidance on Data Integrity as it relates to SAP systems.
• Experience with SAP-specific compliance controls such as:
  • SAP GRC (Access Control, Process Control, Risk Management)
  • SAP security & role design
  • Audit trails and change logs in SAP
  • SAP transport management and change management
• Strong collaboration skills with SAP functional and technical teams, IT, and Quality stakeholders.

Salary Range: Principal: $133,000 – $183,700

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI offers a robust total rewards strategy including annual bonus structure, medical/dental/vision coverage, paid PTO and holidays, sabbatical program, 401(k) matching with 100% vesting in 60 days, and employee recognition programs.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc.

has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.