Role Title: GxP Sox GRA Compliance Manager Duration: contract to run until 18/02/2025 Location: Remote Role purpose / summary Our client is looking fro a GxP, SOX, Complaince Lead To manage various IAM, PAM & IGA realted GxP fulfilments in the Project such as; Regulatory Compliance Management: Ensure compliance with GxP standards (Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice) across relevant processes in manufacturing, clinical trials, quality control, and laboratory settings.
Lead the organization's compliance with Sarbanes-Oxley (SOX) Act, focusing on internal controls over financial reporting, documentation, and audit readiness.
Develop and maintain policies and procedures that support compliance with GxP, SOX, and other relevant regulatory frameworks (e.g., FDA, EMA, ISO standards).
Risk Management & Internal Controls: Implement and monitor effective internal controls to ensure financial accuracy and integrity as per SOX Section 404.
Conduct regular risk assessments to identify compliance gaps and areas of improvement related to GxP and SOX requirements.
Oversee internal audits and self-inspections to verify adherence to GxP, SOX, and company policies.
Audit & Inspection Management: Serve as the point of contact for regulatory agencies (e.g., FDA, EMA) and manage external audits related to GxP compliance.
Coordinate SOX compliance audits, ensuring proper documentation and testing of internal controls.
Prepare and manage responses to audit findings, working with stakeholders to resolve issues and implement corrective actions.
Training & Awareness: Develop and deliver training programs on GxP, SOX compliance, and other regulatory requirements to ensure employees are aware of and adhere to relevant guidelines.
Foster a culture of compliance within the organization by promoting ethical behavior and accountability.
Compliance Monitoring & Reporting: Continuously monitor compliance performance metrics, reporting key findings to senior management and the board of directors.
Prepare compliance reports and documentation for external audits, regulatory submissions, and internal reviews.
Ensure timely filing of all SOX documentation, including risk management assessments, financial controls, and remediation actions.
Collaboration & Leadership: Work closely with Finance, Quality Assurance, Operations, IT, and other key departments to ensure that GxP and SOX compliance objectives are met.
Lead the compliance team and provide guidance on regulatory interpretations, emerging risks, and best practices.
Governance, Risk & Compliance (GRC) Systems: Utilize and manage GRC tools and platforms for tracking compliance activities, internal controls, and audit findings.
Ensure that technology and systems related to SOX financial controls are aligned with compliance requirements.
Key Skills/ requirements Technical Expertise: Strong knowledge of GxP standards (GMP, GCP, GLP) and their application in the life sciences, pharmaceutical, or biotechnology industries.
In-depth understanding of Sarbanes-Oxley Act (SOX), particularly Section 302 (corporate responsibility for financial reports) and Section 404 (management assessment of internal controls).
Experience with risk management, internal controls, and audit processes for financial and operational compliance.
Regulatory Compliance Knowledge: Proven experience managing compliance programs in highly regulated industries, such as pharmaceuticals, medical devices, or financial services.
Familiarity with regulatory requirements from agencies like FDA, EMA, and ISO standards (e.g., ISO 9001, 13485).
Leadership & Communication: Strong leadership skills, with the ability to manage and mentor compliance teams.
Excellent communication and interpersonal skills, with the ability to influence and collaborate with cross-functional teams and senior executives.
Experience in preparing and delivering compliance reports to senior leadership and boards.
Problem Solving & Analytical Skills: Strong analytical skills to assess risk, evaluate internal controls, and develop remediation plans.
Ability to work under pressure and manage multiple projects simultaneously, meeting regulatory deadlines.
All profiles will be reviewed against the required skills and experience.
Due to the high number of applications we will only be able to respond to successful applicants in the first instance.
We thank you for your interest and the time taken to apply!
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