
Chief Compliance Officer
1 day ago
The successful candidate will be responsible for establishing, maintaining, and continually improving the Quality Management System (QMS) in compliance with relevant regulations.
They will have a strong understanding of IVD / Molecular Biology products, as well as experience in leading audits and regulatory inspections.
Key Responsibilities:
- Oversee document and record control, deviations, change control, incidents, OOS, and quality risk management processes.
- Manage Nonconformance and CAPA processes, including root cause analysis and corrective/preventive actions.
- Plan, monitor, and support internal and external audits, and confidently manage regulatory inspections.
- Identify, design, and implement training programs for QA and cross-functional teams to promote a culture of quality and compliance.
- Drive continuous improvement through proactive risk management and cross-functional collaboration.
Required Skills and Attributes:
- Strong understanding of IVD / Molecular Biology products.
- In-depth knowledge of ISO 13485:2016 and ISO 14971 (Risk Management).
- Proven ability to lead audits and regulatory inspections successfully.
- Strong leadership, interpersonal, and team management skills.
- Excellent collaboration and stakeholder management abilities.
- Proactive and solution-oriented mindset, with a strong focus on quality culture.
- High attention to detail and risk-based thinking.
Preferred Qualifications:
- 12 to 15 years of experience in the IVD industry, with at least 3 to 5 years in a leadership/managerial role.
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