Head, 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.

Major Accountabilities:

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. This includes clear definition of responsibilities and accountabilities for all manufacturing responsibilities throughout the business.

Appraise manufacturing performance against objectives and communicate progress to senior leadership

Plan and oversee maintenance programs, inventory controls and validation activities.

Ensure all manufacturing activities comply with global compliance regulations, relevant acts, legal demands and CSL’s Code of Conduct. Ensure product and facility compliance with all relevant regulatory bodies in all target markets with a focus on EMA, TGA and FDA compliance.

Ensure the business provides efficient, effective and compliant execution of quality responsibilities to assure that only materials and products that are safe and fit for purpose are released into the facility, transferred to other sites or into the market.

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, including the execution of all necessary measures in the case of complaints and possible recalls. Ensure the development of suitable measures for the limitation of possible negative impacts.

Ensure optimal inspection readiness, including appropriate preparation to enable a positive execution of any and all regulatory inspections and other third-party audits and the initiation of analysis of inspection results as well as corrective and preventative actions and ensuring that the responses to authorities are given in a timely manner and the commitments are consistent with operations at other CSL facilities.

Plan the optimal utilization of headcount (both permanent and temporary), equipment and material through effective production control techniques to…