Senior Associate - QA Batch Release

At CSL Seqirus, we protect public health through innovative vaccines that save lives around the world. We are currently seeking an experienced Senior Associate – Quality Assurance to support critical quality operations across manufacturing and batch release activities.

This is an excellent opportunity for a quality professional looking to broaden their impact in a highly regulated, fast‑paced pharmaceutical environment.

This will be an onsite role based in Woodend.

The Opportunity

Reporting to the QA Manager, Quality Assurance, you will provide hands‑on QA expertise across QA Batch Release and/or Front-Line QA, ensuring compliance with domestic and international regulatory requirements and supporting safe, compliant product supply.

You will work closely with Manufacturing, MS&T, Quality Control, AS&T, Regulatory Affairs and Supply Chain teams playing a key role in maintaining Seqirus’ strong quality culture.

Key Responsibilities

• Support QA Batch Release and Front-Line QA activities in line with GMP and regulatory requirements.

• Review batch documentation to ensure materials and finished products meet quality and regulatory standards.

• Support and perform batch release activities, including preparation of regulatory release documentation where required.

• Provide shopfloor QA oversight, resolving quality issues and supporting investigations.

• Manage deviations, technical complaints and quality events, including root cause analysis, CAPAs and effectiveness checks.

• Review and approve Change Controls, validation and stability documentation.

• Support audits, inspections and regulatory compliance activities (TGA, FDA and other agencies).

• Collaborate with internal and external stakeholders, including in‑licensing partners and third‑party suppliers.

• Support and guide Associate QA staff and graduates as required.

About You

You are a quality‑focused professional with a strong understanding of GMP and regulated manufacturing environments, capable of working both independently and collaboratively.

You will bring:

• A tertiary qualification in a science‑related discipline.

• At least 2 years’ experience in a Quality/Operations/Quality Operations role within a regulated industry (pharmaceuticals, biologics, medical devices or similar).

• Sound knowledge of GMP, Quality Risk Management and QA/QC systems.

• Experience working with Quality Management Systems / Pharmaceutical Quality Systems.

• Strong written and verbal communication skills and excellent attention to detail.

• The ability to manage multiple priorities and meet timelines in a fast‑paced environment.

• The ability to influence compliant Quality outcomes in a shop-floor capacity with Manufacturing and/or Quality Control teams.

• Experience with quality systems such as TrackWise, Veeva QMS/QDocs, SAP (highly desirable).

What We Offer

• The opportunity to work with a global leader in vaccine manufacturing.

• Exposure to complex, high‑impact products that protect communities worldwide.

• A collaborative and supportive quality culture with strong development opportunities.