Executive Director, Manufacturing & Site Head

Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people’s lives. It’s a feeling of possibility, creativity, and purpose that inspires us every day.

Responsibilities

Reporting to the Global Head of Manufacturing, the Executive Director, Manufacturing & Site Head will lead and direct Seqirus Influenza 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 product gets delivered on schedule and within budget. This individual will also serve as the Site Head enabling a high degree of cross functional collaboration and communication across the site. 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.

MAJOR ACCOUNTABILITIES:

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 achieve budget, product quality, compliance and timely supply objectives

Identify and implement continuous process, productivity, and cost improvements

• Develop and implement effective processes and systems to ensure Seqirus products meet operational, regulatory and business plan schedules.
• Direct research into innovative technologies and production methods and implement new initiatives.
• Drive a culture of risk-based continuous improvement across the business to drive development and operational excellence.
• Lead and drive strong business and financial competency in the management of manufacturing materials, COGs and the P&L.
• Direct the analysis of expenditure base to identify opportunities for cost reduction and productivity improvements.

Perform Site Head responsibilities

• Lead the Site communications and engagement activities to develop cross functional working, foster collaboration and develop the Site community
• Lead the Site Leadership Team to develop, manage and cascade a Site wide plan that captures the goals and tactics, from across the functions.
• Ensure that the cross functional governance and project forums are sponsored and supported appropriately, delivering outputs as required.
• Lead the site leadership team through the annual people processes, included talent review and performance calibration
• Be the legal signatory and/or authorized person, for any statutory, regulatory, governance, environmental and safety matters.
• Be host for internal and external relationships, including Seqirus Leadership, local dignitaries, and local/national government

Provide Site Manufacturing Team Leadership

• Provide leadership and guidance to a site-based Manufacturing team to effectively executive site goals and tactics.
• Set objectives and provide clear direction for execution.
• Responsible for organizational design and staffing decisions.
• Responsible for acquisition of top manufacturing talent
• Oversee the ongoing education and development of employees in GxP
• Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.

Qualifications

• B.S. Engineering, Science or related degree required, MS/PhD, MBA desirable
• 12+ years technical experience in biologics or pharma manufacturing, preferably in vaccines
• Experience in leading change in a large regulated manufacturing environment
• 8-10 years Leadership / Line Management experience within a manufacturing environment
• Regulatory awareness / capable to lead FDA and MHRA inspections
• cGMP Awareness
• Network/contact with key opinion leaders / organizations
• Strong team leadership skills including experience within a 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

Capabilities

Worker Type:

Employee

Worker Sub Type:

Regular