AI Compliance and Regulatory Lead

Remote
Full Time
Mid Level
Key Responsibilities:
  • AI Integration in QMS: Provide strategic advice and guidance to clients on the integration of AI and machine learning into their Quality Management Systems. Help clients leverage AI to improve processes like CAPA (Corrective and Preventive Actions), document control, risk management, and audit management while maintaining regulatory compliance.
  • AI and Manufacturing: Advise on the application of AI in manufacturing processes to improve production efficiency, product consistency, and compliance. This includes using AI for predictive maintenance, process optimization, and real-time monitoring of production lines in adherence to GxP (Good Manufacturing Practices).
  • Validation and Compliance: Lead projects focused on validating AI systems and tools in regulated environments (e.g., 21 CFR Part 11, EU Annex 11, GxP). Develop risk-based approaches to validate AI-driven systems and ensure they meet regulatory standards for documentation, traceability, and performance.
  • Regulatory Advisory: Provide expert advice on the evolving regulatory landscape surrounding AI in life sciences. Stay up to date on the latest regulatory guidance from agencies such as the FDA, EMA, and ICH and ensure clients are compliant with relevant AI-related standards and guidelines.
  • Training and Development: Design and deliver training programs for clients to help them understand AI's role in QMS, manufacturing, and validation. Empower teams to leverage AI tools while maintaining compliance and quality.
  • Change Management and Risk Management: Develop and implement strategies for managing changes in processes, systems, and technologies as AI solutions are introduced into existing infrastructures. Ensure that changes are compliant with industry regulations and standards. Implement effective risk management frameworks to mitigate risks introduced by AI.
  • Data Integrity and Security: Advise on best practices for ensuring data integrity, security, and privacy when using AI and machine learning models in regulated environments. Support the implementation of data governance policies that meet both regulatory and business needs.
  • Client Relationship Management: Establish and maintain strong relationships with client stakeholders, ensuring alignment between business objectives and regulatory requirements. Collaborate with cross-functional teams to ensure successful project execution.

Qualifications:
  • Education:
    • A Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or a related field.
  • Experience:
    • At least 5+ years of experience in a consulting role, specifically within the life sciences or pharmaceutical industry, with a focus on Quality Management Systems, manufacturing, and validation.
    • Strong expertise in the application of AI technologies within regulated environments. Experience with machine learning, data analytics, and predictive modeling is highly desired.
    • Extensive knowledge of regulatory requirements such as FDA 21 CFR Part 820, 21 CFR Part 11, GxP, ISO 13485, and EU MDR.
    • Proven experience in implementing AI-driven solutions in QMS, manufacturing, and validation processes. Knowledge of AI in Quality Control, Digital Twin, and Predictive Maintenance is a plus.
  • Skills:
    • Technical proficiency: Strong understanding of AI, machine learning algorithms, and their application in regulated environments.
    • Regulatory expertise: In-depth understanding of compliance frameworks and the ability to align AI projects with regulatory expectations.
    • Project management: Demonstrated ability to manage and deliver complex projects, with a focus on quality and compliance, within deadlines and budget.
    • Communication: Strong communication skills, with the ability to clearly articulate complex technical concepts to both technical and non-technical stakeholders.
    • Problem-solving: Ability to analyze complex issues, think critically, and offer practical, actionable solutions.
This is a remote consultant position with no benefits.

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Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to [email protected].
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