Quality Assurance Manager / Authorised Person

About the Role

Olistica Health is bringing a newly retrofitted vault and purpose-built cleanroom online at our Spence Street site in Bungalow, Cairns. The site already holds Queensland Health approval for storage and wholesaling of medicinal cannabis and is preparing for TGA GMP licensing and inspection.

We're hiring the permanent Quality Assurance Manager / Authorised Person (AP) who will run the Quality function for the site going forward — taking handover from our validation and interim-AP consultants as the facility moves from build-out to licensed operation. This is a foundational hire: you'll be the named individual accountable for batch certification and release under our TGA manufacturing licence once it is granted, and the final safeguard confirming that nothing leaves the site unless the quality and compliance evidence supports it.

Scope of Role

Planned initial GMP scope — and therefore this AP appointment — covers:

• Receipt of dried medicinal cannabis flower

• Quarantine and storage of bulk flower/starting material

• Manual packing and labelling

• Finished goods storage

• External laboratory testing and CoA review

• QA batch record review

• AP certification and release for supply

Olistica's plan to expand the site’s scope beyond dried flower packing in future subject to relevant approvals.

What you'll be Responsible for

Batch certification & release — reviewing manufacturing and QC documentation for each batch, confirming compliance with licence conditions, GMP, validated processes and specifications, and authorising release only when the evidence supports it.

• Maintaining a state of control — verifying the vault, cleanroom, equipment and utilities remain qualified and within their validated conditions; monitoring cleaning and environmental controls relevant to a manual packing operation.

• Deviation, OOS/OOT, complaint and CAPA oversight — ensuring investigations identify true root cause, challenging weak root-cause analysis or CAPA, and verifying CAPA effectiveness before closure.

Document control and approval — taking ownership of the site's controlled document set (SOPs, forms, protocols) at handover from the interim AP, and approving new and revised documents from that point.

• Validation oversight — reviewing and approving IQ/OQ/PQ protocols and reports produced by our validation consultant.

• Supplier and laboratory quality — establishing and maintaining quality agreements with contract testing laboratories, and reviewing CoA/CoC evidence as part of release decisions.

• Data integrity — promoting ALCOA+ practice and identifying documentation or data-integrity risks across the site.

• Regulatory readiness — maintaining the Site Master File and supporting documentation for the TGA inspection, and acting as the site's quality representative during it; direct contact and communication with the TGA on quality and inspection matters, with support from the consultant team; liaising with ODC and Queensland Health as the named quality contact.

• Training — building and owning the AP and site training matrices, and delivering/verifying GMP training for production staff.

• Working alongside the Operations Manager, our Regulatory Affairs lead, and our validation consultant through go-live, then owning quality operations independently post-licensing.

Appointment and Authorisation

This is a formally appointed role, not a title that comes with the offer letter. Before independent release authority is granted, Olistica requires:

1. A documented review of your qualifications, GMP experience, and batch-release decision-making background against the role.

2. Completion of role-specific AP training (PIC/S GMP as adopted by TGA including Annex 16 batch-certification principles, Olistica's licence conditions once granted, our PQS and SOPs, and Queensland Health/ODC controls as applicable).

3. A practical competency assessment against representative or live batch documentation — confirming you can review a full release package and reach a justified release, delay, reject, or escalate decision.

4. Written Senior Management authorisation defining your scope of authority, effective date, and review date, with independence from production/commercial release pressure documented in that record.

Any gaps identified during this process are closed before you take on independent release decisions. We'll support this with our regulatory consultant. During the transition, our interim AP arrangement continues in parallel until your authorisation is complete and formally handed over.

What you'll Need

• Tertiary qualification in pharmacy, chemistry, pharmacology, biological science or a related discipline.

• Demonstrated GMP experience and prior batch-release or quality-decision-making responsibility, ideally including prior service as an Authorised Person, within a TGA-licensed, ODC-licensed, or comparable GMP-regulated environment. Medicinal cannabis experience is highly valued but not mandatory if your GMP and batch-release background is strong.

• Working knowledge of PIC/S GMP as applied in Australia, and direct experience with TGA and/or ODC inspections or audits.

• Confidence reviewing batch production records, CoA/CoC documentation, deviations, OOS/OOT, CAPA and change-control evidence, and making a defensible release decision — and the independence to delay or reject release when the evidence doesn't support it, regardless of commercial pressure.

• Comfortable owning document control at volume — this role inherits a substantial backlog of SOPs and forms mid-finalisation and needs to keep pace with a live inspection countdown.

• Ability to satisfy a "fit and proper person" check, including a national police check, as required for S8/controlled-substance site licensing.

• Full working rights in Australia. Site-based role — this is not a remote or hybrid position given the vault/cleanroom access and controlled-substance handling requirements.

Reporting and Start

Reports to Olistica's Executive Officer and works alongside the Operations Manager on-site. We're looking to move quickly given the inspection timeline — interviews are underway now for an immediate start, allowing meaningful handover and authorisation time ahead of inspection in early Q4 2026.