Quality Systems Manager

Full time, part time or reduced hours considered. Level and title flexible depending on experience.

Remagine Labs is a MedTech startup developing wearable electro-pharmaceutical drug delivery devices for chronic conditions, including epilepsy. Our patch combines a hydrogel drug reservoir, integrated electronics and controlled iontophoretic delivery. We are backed by a licence and development partnership with a global biopharmaceutical company. Our first clinical manufacturing campaign and Phase 1 study are ahead of us.

Take our quality management system from early implementation to clinical-stage readiness, and own it from there. Our electronic QMS platform is selected and initial configuration is underway. You will assess what is in place, complete the build, author the procedures, and get us audit-ready across both the device and drug sides of a combination product. This is a hands-on role reporting to the CEO.

We are open on level. You may set quality strategy and execute it outright, or run the system day to day with strategy and regulatory interpretation from our retained quality consultant. Tell us in your application which of these you are and we will scope the role, title and package accordingly.

• Complete configuration and validation of our electronic QMS, and establish document, change and training control that sticks across the team

• Author the core procedures: document control, change control, CAPA, deviations, supplier quality

• Own the quality framework across device and drug elements, aligned to ISO 13485, FDA QMSR and cGMP

• Maintain design controls and the design history file through design freeze

• Establish GMP documentation for the drug product: master batch records, specifications, batch review and release

• Support qualification of the clinical manufacturing suite and give quality oversight of the Phase 1 campaign

• Qualify suppliers and contract manufacturers, and own the quality agreements

• Run internal audits and prepare us for inspection

Essential

• Tertiary qualification in a scientific, engineering or technical discipline

• 3+ years in quality roles within regulated medical device or pharmaceutical manufacturing

• Hands-on experience with an electronic QMS, including document control, change control and training records

• Working knowledge of ISO 13485 and FDA QMSR, or of pharmaceutical GMP (21 CFR 210/211 or the PIC/S Guide to GMP)

• Willing to write procedures and records yourself, in a small team with no one below you to delegate to

• Full working rights in Australia

Highly desirable

• Drug-device combination product experience, including familiarity with 21 CFR Part 4

• A product taken through FDA clearance or approval, or TGA registration

• Electronic QMS implementation or migration, including system validation

• Startup experience, clinical-phase manufacture of investigational product, or transdermal and wearable experience

You come with a recommendation rather than a menu of options, close items out rather than leaving them open, and take work off the technical team rather than adding to it. You know the difference between what a Phase 1 startup must have and what a commercial-stage manufacturer needs, and you do not gold-plate.

A quality system in its earliest stages and the mandate to own it. Strategic backup from an experienced quality consultant, so you are not carrying the regulatory judgement alone. A direct line to the CEO, exposure across device engineering, formulation and clinical programmes, equity participation and flexible hybrid working.

Remagine Labs is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all team members.

click “Quick Apply” with your resume and a short cover letter telling us which shape of the role fits you, and describing a quality system or electronic QMS you have worked on.