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Role Overview
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, ensuring that high-quality products are delivered on schedule and within budget. It is also accountable for the safety of both products and the site, including all workers. The individual will serve as the Site Head, enabling a high degree of cross-functional collaboration and communication across the site to ensure it delivers on its objectives. This role 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. As a member of the Global Operations Leadership Team, the individual is responsible for contributing to the overall strategy and Global Operations strategy.
Major Accountabilities
- Strategic View of Manufacturing Function: Work with the SVP Operations and VP Supply Chain to create and maintain a global and strategic view of the Manufacturing function.
- Multi-year Manufacturing Strategy: Develop a multi-year manufacturing strategy considering impacts of products, volumes, and site/geographic expansion – technical transfers through to fill-finish.
- External Relationships: 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.
- Accountability for Delivery: Accountable for on-time, quality delivery of manufacturing strategic projects.
- Capital Expenditure Projects: Oversee capital expenditure projects for Manufacturing to ensure completion of schedule within established budgetary guidelines.
- Strategic Projects Implementation: Initiate and coordinate strategic projects and enable consistent implementation across sites, globally.
- Maintenance and Inventory: Oversee maintenance programs, inventory controls, and validation activities.
Lead Site Manufacturing Activities
- Functional Manufacturing Operation: 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.
- Performance Appraisal: Appraise manufacturing performance against objectives and communicate progress to senior leadership.
- Compliance and Quality: 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.
- Quality Assurance: 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.
- Relationship Management: Proactively manage internal and external relationships to deliver on goals.
- Drug Safety: 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.
- Inspection Readiness: 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.
- Resource Utilization: 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.
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Drive a Culture of Operational Excellence
- Continuous Improvement: Drive risk-based continuous improvement across the business to drive implementation of the CSL Operating System (COS) and the Site Management System (SMS).
- Key Performance Indicators (KPIs): Identify and implement key performance indicators (KPIs) to track the impact of improvement/LEAN initiatives across sites.
- Policy Deployment: Lead policy deployment in the areas of Lean Manufacturing techniques, quality, cost reduction, completion, and on-time delivery.
- Expenditure Analysis: Direct the analysis of expenditure base to identify opportunities for cost reduction and productivity improvements.
Provide Manufacturing Technical Direction, Leadership, and Education
- Company Expert: Serve as company expert and resource on manufacturing matters.
- Technical Information Presentation: Present technical information to management to ensure their understanding of the manufacturing issues affecting the company.
- Leadership Interface: Interface with leadership at all levels to understand and proactively address issues affecting manufacturing processes.
- Learning Forums: Facilitate regular learning forums to facilitate knowledge sharing, skill development, and education on new standards/procedures through the organization.
- Technical Solutions: 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.
- Knowledge and Expertise: Ensure that appropriate manufacturing and LEAN knowledge and expertise exist within the manufacturing team to support existing and emerging needs.
Accountable for Global Compliance with Regulatory Standards and Interaction with Health Authorities
- Compliance: Ensure compliance with all safety, Good Manufacturing Practices, regulatory, and company’s policies.
- Quality KPIs: Meet the Quality KPI’s in all areas.
- Employee Education: Oversee the ongoing education and development of employees in GxP and other Quality topics.
- Global Policies: Accountable for global policies and procedures to ensure company, GMP, and regulatory compliance.
Perform Site Head Responsibilities
- Site Communications and Engagement: Lead the Site communications and engagement activities to develop cross-functional working, foster collaboration, and develop the Site community.
- Site Leadership Team: Lead the Site Leadership Team to develop, manage, and cascade a Site-wide plan that captures the goals and tactics, from across the functions.
- Cross-functional Governance: Ensure that the cross-functional governance and project forums are sponsored and supported appropriately, delivering outputs as required.
- People Processes: Lead the site leadership team through the annual people processes, including talent review and performance calibration.
- Legal Signatory: Be the legal signatory and/or authorized person for any statutory, regulatory, governance, environmental, and safety matters.
- Host for Relationships: Be host for internal and external relationships, including Seqirus Leadership, local dignitaries, and local/national government.
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Provide Site Manufacturing Team Leadership
- Leadership and Guidance: Provide leadership and guidance to a site-based Manufacturing team to effectively execute site goals and tactics.
- Clear Direction: Set objectives and provide clear direction for execution.
- Organizational Design: Responsible for organizational design and staffing decisions.
- Top Talent Acquisition: Responsible for acquisition of top manufacturing talent.
- Employee Education: Oversee the ongoing education and development of employees in GxP.
- Employee Engagement: 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’s 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 of leading 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.
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K., and Australia, CSL Seqirus utilizes egg, cell, and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus, and CSL Vifor, visit CSL and CSL Plasma at CSL Plasma.
Our Benefits
For more information on CSL benefits, visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging, visit Inclusion and Belonging.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual
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