Gemma Staddon

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Gemma Staddon

Divisional Manager - Life Sciences

I am a Divisional Manager at HPG, specialising in recruitment within the Life Sciences sector. My focus areas include Medical Affairs, Health Economics & Market Access and Regulatory Affairs working with candidates and clients in the Medical Device & Pharmaceutical industries.

The roles I work on include:

Medical Director
Associate Medical Director
Medical Manager
Medical Lead
Medical Affairs Manager
MSL Manager
Senior Medical Advisor
Medical Advisor
Senior Medical Science Liaison
Medical Science Liaison
Scientific Advisor
Real World Evidence Lead
Medical Excellence
Pharmacovigilance Manger
Senior Pharmacovigilance Associate
Pharmacovigilance Associate
Pharmacovigilance & Compliance
Medical Information
Health Economist
Market Access Manager/Director
Senior Market Access Manager

Director & Associate Director of Market Access
Head of Market Access
Market Access Associate
Senior Market Access Associate
Pricing Manager
Head of Pricing
Police Advisor
External/Government Affairs Manager/Director
Patient Access
Corporate Affairs & Advocacy
ManagerPublic Affairs Manager
Head of Public Affairs
Regulatory Affairs Director
Regulatory Affairs Manager
Regulatory Affairs Project Manager
Senior Regulatory Affairs Associate
Regulatory Affairs Associate
Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Regulatory Affairs Assistant

With more than 10 years of experience in sales and account management, I have spent the past 7 years working in Australia's healthcare industry. During this time, my passion for making a positive impact on patients' lives has grown significantly.

As a dedicated recruiter, I am driven by my passion for the healthcare industry.

I approach each candidate placement and every vacancy I work on with the same level of enthusiasm, recognising the crucial role they play in improving patient outcome.

Specialising in

Jobs by Gemma Staddon.

Medical Affairs,Quality Assurance

Quality & Medical Operations Specialist

Sydney
Competitive salary package

Benefits • Permanent, full-time opportunity • Broad, hands-on role with real ownership and visibility • Collaborative, small-team environment with exposure across the business About the company This opportunity sits within a growing, specialty pharmaceutical organisation operating across Australia and New Zealand. The business focuses on the commercialisation and distribution of medicines across several therapeutic areas. Locally, the team is lean, agile, and in a growth phase, offering genuine influence and autonomy. About the opportunity This is a newly created Quality and Medical Operations Specialist role. The position offers broad responsibility across quality systems, pharmacovigilance, and medical, making it ideal for someone who enjoys being hands-on and building structure in a growing organisation. You will play a key role in ensuring compliance with TGA, GMP, and PV requirements while partnering closely with regulatory, commercial, and external stakeholders. Duties • Own and manage the local QMS including document control, deviations, change control, CAPAs, and continuous improvement activities • Manage product quality complaints, adverse quality events, and investigations in line with TGA expectations • Coordinate quality documentation for imported products, manufacturers, suppliers, and distributors • Act as the local QPPV overseeing adverse event reporting and pharmacovigilance obligations • Submit adverse events to the TGA and maintain an effective PV system • Support readiness for TGA audits and inspections, including preparation and follow-up actions • Develop, review, and maintain SOPs, work instructions, and quality policies • Partner with Sales and Marketing teams to embed quality processes into commercial activities • Support medical information activities over time, with structured training provided • Collaborate with Regulatory Affairs on GMP clearances, product changes, and quality-related submissions Skills and experience • Tertiary qualification in Pharmaceutical Sciences, Quality Assurance, or a related discipline • Experience working within a pharmaceutical Quality Management System • Solid understanding of TGA, GMP, and PV requirements in a commercial environment • Experience developing and maintaining SOPs and quality documentation • Strong attention to detail with a practical, solutions-focused mindset • Comfortable working autonomously and building processes where they do not yet exist • Confident communicator able to engage across technical and non-technical stakeholders Culture This organisation offers a down-to-earth, collaborative culture where people are trusted to take ownership. How to apply If this sounds like your next move, click apply or contact Eve Cooke ecooke@hpgconnect.com for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits across Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care, spanning Medical Affairs, Regulatory Affairs, Quality, Pharmacovigilance, Commercial, and Operations roles.

Senior Regulatory Affairs Associate

Sydney
Competitive salary package + company benefits

Benefits • Hybrid working model with flexibility • High-impact role with real ownership and visibility • Work with a high performing global company during a critical growth phase About the company With a strong global footprint, this organisation operates in a highly specialised pharmaceutical space with a growing pipeline. Locally, the team is intentionally lean, creating an environment where individuals have real ownership, visibility, and impact. The business is preparing for its next phase of growth with multiple products moving through key regulatory milestones. About the opportunity This is a senior Regulatory Affairs role within a lean, high-performing local team, created to provide immediate, hands-on regulatory support. The focus is on delivering high-quality regulatory outcomes across pre-submission and submission activities in a fast-moving environment. You’ll work closely with the Director of Regulatory Affairs taking end-to-end ownership of CAT 1 applications, pre-submission work, and dossier preparation. You’ll lead local regulatory activities while collaborating with global teams to ensure high-quality, timely submissions. Duties • Lead and support pre-submission and submission activities with the TGA • Manage CAT 1 applications end to end • Prepare, review, and coordinate regulatory dossiers • Act as a key local regulatory contact with the TGA • Support multiple products transitioning from pre-submission into submission • Balance priorities across a significant workload while maintaining quality and momentum • Collaborate with local stakeholders and limited global teams Skills and experience • Proven hands-on experience managing CAT 1 applications with the TGA • Strong technical regulatory writing capability, including dossier preparation • Comfortable operating autonomously in lean regulatory environments • Experience managing multiple products in parallel • Strong communication and stakeholder management skills • Adaptable, proactive, and confident in decision making Culture Foster a collaborative, hands-on, and adaptable culture where ownership and accountability are valued. This team operates with limited resources, so confidence, energy, and the ability to roll up your sleeves are essential. Team and culture fit are as important as technical capability. How to apply Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com About Healthcare Professionals Group Healthcare Professionals Group recruits across executive, permanent, and contract roles within Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care, spanning Medical Affairs, Regulatory, Commercial, Operations, and Clinical functions.

COMBINED EXPERIENCE

At HPG, we pride ourselves on bringing together a diverse group of professionals with extensive backgrounds in the healthcare recruitment industry. Our combined years of experience and specialised knowledge ensure that we deliver unparalleled service to our clients and candidates. By working collaboratively, we harness our collective expertise to meet and exceed your goals and expectations, providing tailored solutions and exceptional support every step of the way. Discover how our unified team effort drives success in every project we undertake.