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 achieve budget, product quality, compliance and timely supply objectives.
Drive a culture of Operational Excellence across sites
- Drive risk-based continuous improvement across the business to drive implementation of the CSL Operating System (COS) and the Site Management System (SMS).
- Identify and implement key performance indicators (KPIs) to track the impact of improvement/LEAN initiatives across sites
- Lead policy deployment in the areas of Lean Manufacturing techniques, quality, cost reduction, completion and on-time delivery
- Direct the analysis of expenditure base to identify opportunities for cost reduction and productivity improvements.
Provide Manufacturing technical direction, leadership, and education
- Serve as company expert and resource on manufacturing matters.
- Present technical information to management to ensure their understanding of the manufacturing issues affecting the company.
- Interface with leadership at all levels to understand and proactively address issues affecting manufacturing processes.
- Facilitate regular learning forums to facilitate knowledge sharing, skill development, and education on new standards/procedures through the organization.
- Find technical solutions and innovation by bringing to bear a network of external experts and solution providers, technology leaders and IP search companies as appropriate.
- 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:
- Ensure compliance with all safety, Good Manufacturing Practices, regulatory and company’s policies
- Meet the Quality KPI’s in all areas.
- Oversee the ongoing education and development of employees in GxP and other Quality topics.
- Accountable for global policies and procedures to ensure company, GMP, and regulatory compliance
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.
Minimum Requirements:
- Bachelor’s 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
- cGMP Awareness
- Network/contact with key opinion leaders / organizations
- 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
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
