SRG, the leader in the Life Sciences human capital industry, is looking for a Senior IT QA and Compliance consultant to join our client's pharmaceutical. This role will assist in executing technology governance, IT GxP validation activities, SOX compliance activities, and the compliance processes within Information Technology.

This is a fully remote position.

MUST HAVES:

• Minimum of 15 years of related IT experience is required.
• Bachelor's degree in IT, Science, Engineering or related scientific discipline required; Advanced degree (MS, PhD, MBA) preferred
• 5-8 years of experience working in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a GxP role.
• Developing and managing the implementation of formal testing methodologies.
• GxP and SOX audits, including working directly with internal and external auditors.
• Computer system validation, system testing, or quality oversight role.
• Thorough understanding of GxP regulations, guidances, and principles, including of 21 CFR Part 11.
• Knowledge of SOX Information Technology General Controls (ITGCs)

JOB RESPONSIBILITIES:

• Identifies, defines, and leads implementation of proactive, cross-organizational process improvement and change initiatives to establish and sustain an effective and efficient operational environment across regulated GxP and SOX areas.
• Collaborates with QA organization to develop risk-based computerized system validation(CSV)/computerized software assurance (CSA) processes and procedures.
• Ensures computer systems validation is complete per applicables procedures.
• Develops and periodically assesses effectiveness of Information Technology (IT) risk framework.
• Implement Risk Management policies and procedures.
• Oversees and manages IT risks, dependencies, mitigation plans and execution against plans.
• Ensures compliance with Information Systems LifeCycle for technology projects.
• Establishes and maintains a SOC report review process within IT.
• Acts as Test Lead for IT System implementations, as needed.
• Reviews ISLC deliverables as IT Governance.
• Conducts internal monthly IT audits for critical processes such as onboarding / offboarding.

* Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.