Head, Manufacturing

Responsibilities

• Lead and direct the Seqirus Influenza manufacturing business strategy and activities to achieve profitability and business objectives.
• Create and maintain a global strategic view of the manufacturing function in partnership with SVP Operations and VP Supply Chain.
• Develop a multi year manufacturing strategy that considers product impact, volume, site and geographic expansion, including technical transfers and fill finish.
• Build and maintain external relationships with third party suppliers, partners, key customers and professional organisations while monitoring future market trends.
• Lead on time, quality delivery of manufacturing strategic projects and oversee capital expenditure projects to ensure completion within budget.
• Initiate and coordinate strategic projects and enable consistent implementation across sites globally.
• Oversee maintenance programmes, inventory controls and validation activities.
• Lead site manufacturing activities to deliver against plan and achieve profit targets, ensuring effective operation of the manufacturing operation.
• Appraise manufacturing performance against objectives and communicate progress to senior leadership.
• Ensure all manufacturing activities comply with global compliance regulations, relevant acts, legal demands and CSL's Code of Conduct.
• Maintain product and facility compliance with EMA, TGA and FDA regulations and ensure compliant execution of quality responsibilities.
• Manage internal and external relationships to deliver on goals, including complaints, recalls and corrective actions.
• Ensure optimal inspection readiness and drive timely responses to regulatory authorities.
• Plan headcount and resource utilisation through effective production control techniques to meet budget, quality, compliance and supply objectives.
• Drive a culture of Operational Excellence across sites, implementing CSL Operating System (COS) and Site Management System (SMS).
• Identify and implement key performance indicators (KPIs) to track the impact of improvement/lean initiatives.
• Deploy lean manufacturing techniques, quality, cost reduction, completion and on time delivery policies.
• Direct expenditure analysis to identify opportunities for cost reduction and productivity improvements.
• Provide manufacturing technical direction, leadership and education; serve as company expert on manufacturing matters.
• Present technical information to management and proactively address issues affecting manufacturing processes.
• Facilitate regular learning forums to share knowledge, skill development and education on new standards and procedures.
• Find technical solutions and innovations through external experts, solution providers and technology leaders.
• Ensure compliance with regulatory standards and interaction with health authorities, meeting all safety, GMP and company policy requirements.
• Oversee ongoing education and development of employees in GxP and other quality topics.

Qualifications

• Bachelor's or master's degree in a science or business related field (PhD, MBA, MSc desirable).
• 15+ years in biopharmaceutical or related industry; 10+ years in leadership/line management within a manufacturing environment.
• Experience leading change in a large regulated manufacturing environment.
• Regulatory awareness, capable of leading FDA and MHRA inspections; cGMP awareness.
• Strong team leadership, influencing, communication and team building skills.
• Results driven, highly motivated, robust, resilient and with proven technical competency.
• Hands on Operational Excellence experience.

Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please contact the recruitment team.