Description:
We are seeking a Certifications & Compliance Manager to own our certification lifecycle and rigorously enforce ISO, GMP, WHO and DRAP requirements across the organization. This leader will design and execute our internal audit program, drive corrective actions, and ensure that every process—from product development through release—meets the highest international and national regulatory standards.
Key Responsibilities:
Certification Governance
- Serve as the single point of accountability for ISO 9001, 10993, 13485, 7886-1, 14001, 45001 and GMP certifications.
- Liaise with WHO PQ, DRAP and Notified Bodies to schedule and host initial, surveillance and recertification audits.
- Maintain up-to-date registers of certificates, scopes, audit reports and renewal deadlines.
Internal Audit & Compliance Monitoring
- Develop a risk-based annual audit schedule covering QMS, biocompatibility, sterility, environmental and OHS systems.
- Execute audits per ISO 19011, document nonconformities, lead root-cause analysis and oversee CAPA closure.
- Continuously monitor process KPIs and regulatory changes; update procedures to reflect new WHO/DRAP guidance and ISO amendments.
GMP Oversight
- Implement and enforce GMP principles in manufacturing, labeling, documentation and traceability.
- Conduct periodic walkthroughs, environmental monitoring reviews and batch-record inspections to detect deviations early.
Policy & Documentation Control
- Own creation, revision and distribution of SOPs, work instructions, risk-management files and validation protocols.
- Ensure document control practices meet FDA, EU-MDR and DRAP requirements.
Training & Culture Building
- Design and deliver targeted training programs on ISO standards, GMP practices, WHO PQ criteria and DRAP regulations.
- Champion a culture of quality, safety and regulatory excellence at all organizational levels.
Qualifications & Experience:
- Bachelor’s or Master’s in Engineering, Life Sciences, Quality Management or related field.
- 5+ years in medical-device or pharmaceutical GMP/QMS roles with demonstrable audit and certification management.
- Certified Lead Auditor for ISO 9001, 13485 and at least one of ISO 14001/45001.
- Deep knowledge of ISO 10993 biocompatibility testing and ISO 7886-1 syringe requirements.
- Proven experience interfacing with WHO PQ and DRAP; familiarity with dossier submissions a plus.