I'm currently recruiting for a Quality and Compliance Specialist to join a very interesting Tech Start Up. This is a fully remote role with a strong package. If this role is of interest, please apply today and I will be in touch if your profile is a good fit.
Compliance Specialist/Officer with a strong background in regulatory compliance, specifically within the pharmaceutical and life sciences industries. The role focuses on ensuring that the company's operations and software solutions comply with stringent regulatory frameworks such as GxP, 21 CFR Part 11, GDPR, and the EU AI Act. Below is a breakdown of what they are looking for:
Core Responsibilities
Regulatory Compliance Management
* Develop and oversee compliance programs for pharmaceutical-related regulations (GVP, GxP, etc.).
* Ensure adherence to specific standards such as 21 CFR Part 11 and the EU AI Act for computerized and AI-enabled systems.
Computerized System Validation
* Oversee the validation and qualification of systems used for GxP activities, ensuring they meet regulatory standards.
Audits and Assessments
* Conduct audits of internal processes, systems, and vendors to maintain compliance.
* Investigate compliance issues and implement corrective/preventive actions.
Vendor and Client Management
* Manage vendor qualifications, assessments, and compliance requirements in contracts.
* Ensure smooth onboarding of clients and alignment with compliance protocols.
Collaboration and Training
* Work with cross-functional teams to maintain compliance in all areas.
* Provide training on compliance-related topics like GxP and computer system validation.
Regulatory Monitoring and Updates
* Stay updated with regulatory changes and ensure company policies are aligned.
Key Skills and Competencies
* Strong organizational and time-management abilities.
* Strategic decision-making and KPI-driven performance tracking.
* Knowledge of quality-related pharmaceutical regulations (e.g., ISO, GxP, GVP).
* Practical experience with compliance software and AI-enabled tools.
Requirements
* Education: Bachelor’s degree in a science-related discipline.
* Experience: Minimum 3 years in a similar compliance role in the pharmaceutical industry (preferred).
* Familiarity with quality-related regulations such as ISO standards.
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