Director of Quality Assurance – GMP Biologics

Overview

Director of Quality Assurance – GMP Biologics Jobs in Sydney, New South Wales, Australia at Clinovo

Title: Director of Quality Assurance – GMP Biologics

Company: Clinovo

Location: Sydney, New South Wales, Australia

Contract/Perm: Perm

Job Title: Dir, Quality Assurance

Misc Notes:

• Highly preferred to have someone who comes from a smaller company with a startup mentality
• Someone coming from large pharma will have a difficult time
• Must have TGA license experience.

Company Overview:

This is a next-generation RNA-focused CDMO dedicated to advancing the production of pDNA, mRNA, and lipid nanoparticle (LNP) formulations for global biopharmaceutical innovators. During Q2 2026, the aclient will launch and operate this end-to-end, state-of-the-art GMP manufacturing facility in Sydney. The facility will serve as a center of excellence for RNA therapeutic and vaccine manufacturing, combining scientific excellence with agile, scalable production services. This is a chance to join the leadership team of one of New South Wales' most innovative biotechnology companies and be at the forefront of pharmaceutical development in Australia.

Client is an equal opportunity employer. We are committed to building a high-performing team where appointments are based on merit, and where a diverse range of perspectives, experiences and backgrounds are welcomed as essential to sustainable success.

Role Summary:

Cliet is seeking an experienced, hands-on quality leader who will build-out, lead, and continuously strengthen our GMP quality function. This role will own GMP QA operations and batch disposition across internal and external manufacturing, provide strategic and operational quality leadership, and ensure the organization remains inspection ready as it scales. The Head of Quality / Director, Quality Assurance will report to company General Manager and partner closely with Technical Operations, Manufacturing, CMC, Regulatory Affairs, and external partners to support business needs, and deliver solutions that drive compliance, risk-based decision making, and continuous improvement.

This role scales beyond a standard QA leadership role. This individual must be solution driven, bring decisive decision-making ability to complex problems, including to make and defend quality decisions, own batch disposition and product release activities. The individual will represent the company with professionalism, support company’s business goals, and build credibly —

Key Responsibilities:

· Lead the company’s quality strategy, quality systems implementation and functioning, and GMP compliance framework in alignment with the Company’s business needs, growth, product lifecycle needs, clients’ and regulatory expectations

· Develop and execute phase-appropriate quality oversight of operations and production

· Develop fit-for-purpose quality plans to support corporate goals from Facility startup, GMP licensing to clients’ batch product release

· Reinforce and instill a quality mindset deeply into the operating culture of the company as it scales to market

· Establish and maintain effective QA oversight for internal operations and external CDMO/CMO partners, including quality agreements, routine oversight, escalation, and governance

· Own batch disposition and product release activities, including review and approval of batch documentation, assessments, investigations, product impact evaluations, and final release decisions

· Operate as the senior quality representative during TGA inspections and other health authority interactions, lead inspection readiness, support inspection management, coordinate responses, and drive remediation activities

· Develop, implement, manage, and continuously improve a fit-for-purpose Quality Management System (QMS), including SOPs, training, document control, deviation management, CAPA, change control, risk management, and management review

· Provide proactive quality input to manufacturing, supply, technical operations, quality control, and regulatory teams, balancing compliance requirements while enabling execution in a fast-paced environment

· Drive quality metrics, trend analysis, and continuous improvement initiatives to identify risks, strengthen operational performance, and close compliance gaps

· Lead root-cause analysis and risk-based decision making for complex quality events, ensuring timely escalation, robust corrective actions, and sustainable prevention measures.

· Lead quarterly management reviews, report to company’s leadership in a timely manner on real-time risk matrix for the Facility's general operations and on a Manufacturing project basis

· Build and lead a high-performing quality team, while remaining engaged in work hands-on and as needed in a lean startup environment

· Promote a strong culture of quality, accountability, and inspection readiness across company and its external network.

Qualifications and Skills:

· 10+ years of progressive experience in Quality Assurance / GxP leadership roles within a regulated pharmaceutical, biotechnology, or advanced therapeutics environment

· Demonstrated experience in GMP QA operations with direct authority or substantial accountability for facility operation, batch disposition and product release

· Direct experience supporting, leading, or fronting regulatory inspections; prior TGA inspection experience is strongly preferred

· Experience operating successfully in a startup, scale-up, or otherwise high-growth environment, including building or maturing phase-appropriate quality systems and processes

· Strong knowledge of cGMP requirements, ICH guidelines, quality risk management, deviation and CAPA systems, change control, and inspection readiness practices

· Experience developing real-world quality plans and processes, balancing the Company’s business goals and compliance requirements

· Experience working at or with CDMOs/CMOs and managing external quality oversight in a multi-stakeholder environment

· Excellent written and verbal communication skills, with credibility and judgment to represent quality decisions clearly to regulators, executives, and cross-functional teams

· Demonstrated ability to influence, challenge constructively, and make sound, timely decisions in situations involving quality risk and ambiguity

· Bachelor’s degree or higher in life sciences, pharmacy, chemistry, biotechnology, engineering, or a related scientific discipline.

Differentiating qualifications:

· Direct experience with TGA inspections, responses, and ongoing engagement in the Australian regulatory environment

· Experience in mRNA, LNP, biologics, sterile/aseptic manufacturing, or other complex regulated modalities

· Experience across clinical, launch, and commercial manufacturing stages

· Hands-on familiarity with electronic quality systems such as Veeva, TrackWise, QDocs, or comparable platforms

· Prior experience building quality organizations and quality culture from early-stage operations through commercial readiness

· Aware and ideally well-grounded in key business principles such as business operations, financial management, business scaling, managing growth, and similar relevant to creating a high-impact company.