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Biologit is an innovator in pharmacovigilance (PV), revolutionising the way that life science organisations handle literature review and monitoring, using cutting-edge automation technology wherever appropriate. Founded with a mission to enhance patient safety and operational efficiency, Biologit empowers pharmaceutical, biotech and PV service providers to simplify and streamline their processes. At the heart of Biologit’s Platform is its AI-powered literature automation tool, designed to transform manual and time-intensive tasks into seamless, efficient workflows. Biologit adheres to the highest industry standards, including ISO 27001 certification, GxP compliance, and alignment with FDA regulations.
Role Description
This is a full-time remote role for a Compliance Specialist at Biologit. The Compliance Specialist at Biologit will play a critical role in ensuring our operations adhere to stringent regulatory requirements (GxP, CFR 11, GDPR and EU AI Act). You will be responsible for developing, managing and overseeing compliance activities, conducting audits, maintaining and reviewing vendor qualifications and assessments, and providing guidance to cross-functional teams.
Key Responsibilities:
1. Develop, implement, and maintain compliance programs to ensure adherence to GVP, GxP, 21 CFR Part 11, and the EU AI Act.
2. Oversee the validation and qualification of computerised systems (including AI enabled software) used for GxP activities, ensuring full compliance with relevant regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11).
3. Manage change management and coordinate risk assessments and impact analyses for new systems, ensuring their suitability for regulated use.
4. Conduct regular audits and assessments of internal processes and systems to ensure compliance with regulatory requirements.
5. Investigate and resolve compliance issues, and implement corrective and preventive actions.
6. Provide support and develop vendor management and assessment.
7. Develop and maintain vendor contracts that include compliance requirements, ensuring proper documentation and communication channels.
8. Collaborate with clients to ensure smooth onboarding processes and align their needs with internal compliance protocols.
9. Serve as point of contact for compliance-related issues with clients, addressing their concerns and ensuring their projects comply with all regulations.
10. Collaborate with cross-functional teams to ensure compliance in all areas of the business, including engineering, product development, pharmacovigilance, operations, and quality assurance.
11. Provide guidance and training to staff on compliance-related matters, including GVP, GxP, and computer systems validation.
12. Monitor and interpret changes in relevant regulations and standards, and update company policies and procedures accordingly and foster continuous improvements.
Requirements:
1. Bachelor’s degree in a Science related discipline.
2. Desirable a minimum of 3 years experience working in a similar role in the pharmaceutical industry.
3. Knowledge of quality-related pharmaceutical regulations, including ISO.
What We Offer:
Competitive salary and benefits.
Opportunity for growth and development.
Flexibility working conditions.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Software Development
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