Senior National Compliance Advisor – Healthcare & GMP

Sigma Healthcare Limited; Melbourne; Híbrido; AUD 110.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Employee discounts and benefits

EAP services

Canteen subsidy

Shuttle service to stations

Descripción de la vacante

Sigma Healthcare is seeking a seasoned Compliance Advisor to lead national regulatory compliance across its pharmaceutical wholesaling operations in Australia. Reporting to the Head of Quality & Compliance, the role ensures CSO obligations, state and federal health regulations, and related frameworks are met with strong governance.

You will oversee audits, licensing, and inspections, manage regulatory reporting, and maintain a robust compliance framework while guiding cross-functional teams

Formación

• A tertiary qualification in Pharmacy, Health Science or a related discipline.
• Experience in a compliance or regulatory role.
• Strong knowledge of pharmaceutical wholesaling regulations including CSO and poisons licensing frameworks.
• Experience managing regulatory audits, inspections and complex reporting obligations.
• Strong understanding of GMP and ISO compliance.
• Business continuity frameworks.

Responsabilidades

• Lead end-to-end CSO compliance and reporting, including monthly, quarterly, and annual submissions and reconciliations.
• Oversee state, territory and federal health regulatory requirements, licensing and audits.
• Manage Department of Health inspections, Schedule 8 audits and PAN validations.
• Coordinate APCO, NIAA reporting with internal stakeholders.
• Develop and maintain a robust regulatory compliance framework with governance and metrics.
• Monitor regulatory changes and advise on emerging risks and obligations.
• Support Business Continuity Plans and contribute to quality and compliance strategy.
• Act as a key contributor within the QMS and lead multiple compliance projects.

Conocimientos

Regulatory compliance

Audits & inspections

GMP & ISO knowledge

Business continuity

Analytical skills

Communication with regulators

Autonomous working

Visio

Educación

Bachelor's degree in Pharmacy, Health Science or related

Herramientas

SharePoint

Excel

Visio

Descripción del empleo

Sigma Healthcare is seeking a seasoned Compliance Advisor to lead national regulatory compliance across its pharmaceutical wholesaling operations in Australia. Reporting to the Head of Quality & Compliance, the role ensures CSO obligations, state and federal health regulations, and related frameworks are met with strong governance.

You will oversee audits, licensing, and inspections, manage regulatory reporting, and maintain a robust compliance framework while guiding cross-functional teams