Compliance Advisor

Sigma Healthcare; City of Melbourne; Hybrid; AUD 110,000 - 150,000; Full time

Benefits offered by this job

Hybrid work model

Employee discounts and benefits

EAP services

Canteen subsidy

Shuttle service to stations

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory compliance

Audits & inspections

GMP & ISO knowledge

Business continuity

Analytical skills

Communication with regulators

Autonomous working

Visio

Education

Bachelor's degree in Pharmacy, Health Science or related

Tools

SharePoint

Excel

Visio

Job description

We are seeking a seasoned Compliance Advisor to play a critical role in safeguarding the integrity of one of Australia’s leading healthcare organisations.

We’re seeking an experienced Compliance Advisor to lead national regulatory compliance across our pharmaceutical wholesaling operations. Reporting to the Head of Quality & Compliance, this role is pivotal in ensuring we meet our obligations under the Community Service Obligation (CSO), state and federal Department of Health regulations, and a range of broader compliance frameworks.

This is a highly visible role that partners closely with regulators, senior leaders and cross‑functional teams to drive strong governance, risk management and continuous improvement.

As Compliance Advisor, you’ll own and lead a broad compliance portfolio, including:

• End to end management of CSO compliance and reporting, including monthly, quarterly, annual submissions and annual reconciliation
• Oversight of state, territory and federal health regulatory requirements, including licensing and audits
• Managing Department of Health inspections, Schedule 8 audits and Pharmacy Approval Number (PAN) validations
• Playing a key role in Australian Packaging Covenant Organisation (APCO), Indigenous Procurement (NIAA) and related non-financial regulatory reporting, in partnership with internal stakeholders
• Developing and maintaining a robust regulatory compliance framework, including governance, metrics and executive reporting
• Proactively monitoring regulatory changes and advising the business on emerging risks and obligations
• Supporting and maintaining Business Continuity Plans in line with organisational frameworks
• Contributing to quality and compliance strategy, training and continuous improvement initiatives
• Acting as a key contributor and approver within the Quality Management System (QMS)
• Leading and participating in multiple concurrent compliance and quality-related projects with tight timelines

Who are we looking for?

The successful candidate will possess the following key skills and experience:

• A tertiary qualification in Pharmacy, Health Science or a related discipline
• Experience working 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 Good Manufacturing Practice (GMP) and ISO compliance
• Business continuity frameworks
• Advanced communication skills, with the confidence to engage regulators and senior executives
• Strong analytical skills and exceptional attention to detail
• The ability to work autonomously while partnering effectively across the business
• Experience with SharePoint, advanced Excel, financial acumen and process mapping tools (e.g. Visio) will be highly regarded
• Opportunities for career advancement and professional development including our people leadership program.
• Employee discounts on a wide range of products as well as corporate discounts on Healthcare Premiums and Novated Leasing.
• Hybrid working model: 4 days from the Preston office and 1 day working from home.
• Access to EAP services.
• Subsidised onsite canteen.
• Complimentary shuttle bus service from the nearby train stations to support public transport users.

Make a genuine impact on national healthcare compliance and patient access in a high‑trust, senior role where your expertise has real visibility and influence, working alongside passionate leaders across quality and operations in an organisation committed to safety, integrity and continuous improvement.