As project manager, you are responsible for planning, executing and monitoring remediation programs designed to correct vulnerabilities and security gaps identified during assessments carried out by the engineering team, in compliance with regulations specific to the pharmaceutical industry.
You ensure coordination between the various technical and business teams, and ensure compliance with deadlines, budgets and security standards, paying particular attention to the protection of sensitive data.
You interact as a real conductor, building up your team and directly supervising project leads.
Your main tasks :
1/ Planning and managing remediation programs
- Analyze security gap assessment reports provided by engineering.
- Define remediation priorities based on risks, business impact and regulatory requirements (e.g. GDPR, HIPAA if the company operates in the USA, etc.).
- Develop detailed remediation plans, including objectives, deadlines, resources, budgets and validation procedures.
- Monitor the progress of remediation projects and ensure regular reporting to management, including specific compliance-related indicators.
2/ Coordination and communication
- Work closely with engineering, operations and development teams, Quality/Compliance teams and other stakeholders, including business units (e.g. R&D, production, regulatory affairs).
- Lead project follow-up and coordination meetings, ensuring traceability of decisions and actions.
- Communicate effectively on the progress of remediations, any sticking points and impacts on compliance.
- Ensure communication with internal and external auditors, regulatory authorities and certification bodies.
3/ Risk and compliance management
- Identify and assess risks linked to security vulnerabilities and gaps, taking into account the specificities of the pharmaceutical sector (e.g. theft of research data, production interruption, counterfeiting).
- Implement appropriate mitigation and control measures, in line with regulatory requirements and industry best practices (e.g. GxP - Good Practices).
- 4/ Continuous improvement
- Identify areas for improvement in remediation processes, security assessments and compliance checks.
- Contribute to the development of tools, methodologies and procedures, taking into account regulatory changes and threats.
- Participate in technological and regulatory monitoring of security and compliance in the pharmaceutical sector.
