Site Head & VP Manufacturing

Reporting to the Global Head CSL Manufacturing, the Site Head and VP Manufacturing will lead and direct Seqirus Influenza (and Products of National Significance in AUS) manufacturing business strategy and activities to achieve profitability and business objectives within the site. This role has end to end accountability for manufacturing at the site making sure that high quality products are delivered on schedule and within budget. This role is also accountable for the safety of both products and the Site, including all workers.

This individual will also serve as the Site Head accountable for enabling a high degree of cross functional collaboration and communication across the site to ensure the Site delivers on its objectives. This role of Site Head includes performing activities such as creating a site-wide plan with goals/tactics, leading the Site Leadership Team, leading several site-based people processes, and enabling a high degree of employee engagement at the site.

The role is the lead member of the Site Leadership Team providing leadership, mentoring, and guidance to achieve overall site business and activities, and as a member of the Global Operations Leadership Team, where responsible for contributing to the overall strategy Global Operations strategy.

• Working with the SVP Operations and VP Supply Chain to create and maintain a global and strategic view of the Manufacturing function.
• Develop a multi-year manufacturing strategy considering impacts of products, volumes, and site/geographic expansion technical transfers through to fill-finish.
• Cultivate and maintain external relationships with third party suppliers and partners, key customers and professional organizations; develop strategies to monitor and identify future market trends.
• Accountable for on-time, quality delivery of manufacturing strategic projects.
• Oversee capital expenditure projects for Manufacturing to ensure completion of schedule within established budgetary guidelines.
• Initiate and coordinate strategic projects and enable consistent implementation across sites, globally.
• Oversee maintenance programs, inventory controls and validation activities.
• Lead site manufacturing activities to deliver against plan and achieve profit targets.
• Ensure the implementation and ongoing operation of a functional 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 CSLs Code of Conduct.
• Proactively manage internal and external relationships to deliver on goals.
• Manufacture products to a quality standard that ensures drug safety, especially regarding the pharmaceutical quality of products.
• Ensure optimal inspection readiness, including appropriate preparation to enable a positive execution of any and all regulatory inspections and other third-party audits.
• Plan the optimal utilization of headcount (both permanent and temporary), equipment and material through effective production control techniques.
• Drive a culture of Operational Excellence across sites.
• Identify and implement key performance indicators (KPIs) to track the impact of improvement/LEAN initiatives across sites.
• Provide Manufacturing technical direction, leadership, and education.
• Present technical information to management to ensure their understanding of the manufacturing issues affecting the company.
• Facilitate regular learning forums to facilitate knowledge sharing, skill development, and education on new standards/procedures through the organization.
• Ensure that appropriate manufacturing and LEAN knowledge and expertise exists within the manufacturing team to support existing and emerging needs.
• Accountable for global compliance with regulatory standards and interaction with health authorities.
• Meet the Quality KPIs in all areas.
• Oversee the ongoing education and development of employees in GxP and other Quality topics.
• Perform Site Head responsibilities.
• Lead the Site communications and engagement activities to develop cross functional working, foster collaboration and develop the Site community.
• Be the legal signatory and/or authorized person, for any statutory, regulatory, governance, environmental and safety matters.
• Provide leadership and guidance to a site-based Manufacturing team to effectively execute site goals and tactics.
• Set objectives and provide clear direction for execution.
• Responsible for organizational design and staffing decisions.
• Oversee the ongoing education and development of employees in GxP.

• Bachelors degree or master degree in a science or business related field.
• Higher level Business or Technical qualification (PhD; MBA; MSc) desirable.
• 15+ years in biopharmaceutical or related experience.
• Experience in leading change in a large regulated manufacturing environment.
• 10+ years in Leadership / Line Management experience within a manufacturing environment.
• Regulatory awareness / capable to lead FDA and MHRA inspections.
• Strong team leadership skills including experience within a TU regulated environment.
• Strong influencing skills / communication skills / team building skills.
• Highly motivated / Results Driven / Robust and resilient / proven technical competency.
• Hands-on Operational Excellence experience.