Background information about the job or company (e.g., role context, company overview)

CSL is seeking an experienced Senior Manager, Quality Control to lead and direct QC operations across two of our critical QC departments (Biochemistry and Sample Management) at our Broadmeadows site.

Reporting to the Site Director for Quality Control, this role is a key member of the site QC Leadership Team and plays a pivotal role in ensuring operational excellence, regulatory compliance and people leadership in a GMP environment.

You will have full accountability for the operational management, quality performance and people leadership of your assigned QC department. You will ensure all QC activities are delivered on time, within budget and in compliance with cGMP, while driving continuous improvement and supporting CSL’s strategic objectives.

Responsibilities or duties

• Provide senior leadership to ensure a safe, compliant and high‑performing QC operation
• Oversee QC testing, Sample management or QC support services in line with cGMP and regulatory requirements
• Manage deviations, OOS, CAPAs, change controls and risk management activities
• Lead inspection readiness and support TGA, FDA and global regulatory inspections
• Develop and deliver operational plans, KPIs and performance metrics aligned to site and global QC strategies
• Drive continuous improvement using risk‑ and data‑based decision making
• Manage departmental budgets, resourcing and financial performance
• Lead, coach and develop managers and technical teams, fostering a strong quality culture
• Collaborate closely with Site Leadership, QA, Manufacturing, Engineering and Global QC networks
• Develop implement and monitor strategic leadership with future site testing services a key feature of the direction of the QC team.

Qualifications or requirements (e.g., education, skills)

Experience needed

• A university degree in natural sciences, pharmacy, chemical engineering or related field and ideally relevant post graduate qualifications (Masters, PhD).
• 7+ years' experience in QC within the pharmaceutical, biotechnology or related GMP/GLP industry.
• Experience in laboratory management involving optimization of operations, testing and method development for a manufacturing environment. Preference for GMP environment.
• 5+ years managing large teams (greater than 15 people) and experience managing other managers and indirect teams including priority setting, decision-making and developing team members.
• Experience in an outcome and timeline focused environment and using commercial judgement to support decisions help implement strategic plans.
• Experience communicating complex information to colleagues across the organisation to achieve outcomes.
• Experience in a role requiring collaboration with teams in different countries and different functions.
• Understanding of GxP principles and the requirements of specific Codes, especially PICs and US CFR requirements.

• Provide senior leadership to ensure a safe, compliant and high‑performing QC operation
• Oversee QC testing, Sample management or QC support services in line with cGMP and regulatory requirements
• Manage deviations, OOS, CAPAs, change controls and risk management activities
• Lead inspection readiness and support TGA, FDA and global regulatory inspections
• Develop and deliver operational plans, KPIs and performance metrics aligned to site and global QC strategies
• Drive continuous improvement using risk‑ and data‑based decision making
• Manage departmental budgets, resourcing and financial performance
• Lead, coach and develop managers and technical teams, fostering a strong quality culture
• Collaborate closely with Site Leadership, QA, Manufacturing, Engineering and Global QC networks
• Develop implement and monitor strategic leadership with future site testing services a key feature of the direction of the QC team.

• Experience in laboratory management involving optimization of operations, testing and method development for a manufacturing environment. Preference for GMP environment.
• Experience managing large teams (greater than 15 people) and experience managing other managers and indirect teams including priority setting, decision-making and developing team members.
• Experience in an outcome and timeline focused environment and using commercial judgement to support decisions help implement strategic plans.
• Experience communicating complex information to colleagues across the organisation to achieve outcomes.
• Experience in a role requiring collaboration with teams in different countries and different functions.
• Understanding of GxP principles and the requirements of specific Codes, especially PICs and US CFR requirements.

• A university degree in natural sciences, pharmacy, chemical engineering or related field and ideally relevant post graduate qualifications (Masters, PhD).
• 7+ years' experience in QC within the pharmaceutical, biotechnology or related GMP/GLP industry.