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Global Head Plasma Quality

Job Description

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!


Job Description

In line with Global Quality strategies, develop and lead the Quality function at CSL Plasma globally. Partners with other executive team members to align the Quality systems with the evolution of the business scope, level of automation and scale of operations, leading the industry in the supply of high quality plasma worldwide. The incumbent in this role is a member of the CSL Plasma Executive Management Team and of the Global Quality Leadership Team. Represents Quality for CSL Plasma globally to internal CSL partners and external strategic partners.

Leadership responsibility for Quality Assurance and Quality Control for collection centers, plasma logistics and release, Supplier Quality Management and Lab QA, ensuring all plasma for further manufacture supplied meets requirements of licensed CSL Behring Product dossiers, and all processes are in compliance with relevant quality standards, regulations, legal and company specific requirements.  In collaboration with CSL Plasma Laboratories and Medical, Operations ensure plasma quality and safety, and donor welfare are reliably suitable and in compliance with relevant Blood Establishment, GLP and GMP regulations globally.

Develop future leaders of CSL through coaching leadership behaviors and skills, development assignments and reinforcement of the CSL values and strengths.

Responsibilities:

  • As a member of the CSL Behring Quality Leadership and Plasma Leadership teams aligns strategic agenda and develops actions to deliver the business outcome with continual focus on improvement and growth.  Leverages global quality program changes for application into the Plasma business line and ensures deployment of industry best practices ok
  • Overall accountability for the quality and compliance of all elements of CSL Plasma, including center operations, distribution centers, and QC laboratories.  Direct the establishment of appropriate quality policies, procedures, infrastructure, capacity, support and training programs to assure the safety and welfare of blood/plasma donors in our collection centers, and the safety and suitability for use of the globally collected or procured plasma for further manufacture.
  • Ensures that all operations are carried out in compliance with local, state and federal regulations, laws and industry standards governing business operations, such as US FDA, US CMS/CLIA, GHA (EMA), Ogyei (EMA), PPTA.
  • Leads plasma quality leaders responsible to manage, motivate and develop professional capabilities of CSL Quality employees (globally) in alignment with business objectives, GxP regulations and industry guidelines. Significant engagement with remote employees is required to be successful.  High dependence on technologically advanced systems for operations, communications and tracking/trending of data, utilizing paperless environments, and cross-site process controls.  Responsible for having the right organizational design and leaders to ensure that the Quality organization can support the growth plans of CSL Plasma. Leads the functional review of performances and merit raises, and the appropriate use of Development plans, especially for high potential employees.
  • Understands external market trends and best practices to actively build understanding of regulator needs and acts collaboratively to influence the evolution of regulations related to our business. Work with industry association(s) as appropriate.  Member of relevant industry associations.
  • Ensures CSL Plasma maintains a Global Quality Management Review process for management oversight and review of Quality performance, including escalation of issues, as appropriate to the Plasma Leadership Team Escalates issues to the Executive Quality Management Review meeting.  
  • Works with peers in the Global Quality Leadership team to develop Quality processes and culture across the CSL Behring network. Works on common initiatives, ensures that the Global Quality Leadership team understand the key regulations, and processes as they relate to plasma collection and contribution of robust quality plasma collection processes on product quality and safety.
  • Develops and manages performance to the annual functional budget designed to meet corporate objectives by review of performance of KPIs such as budget, forecast, cost drivers and audit experience. Periodically, develop forecasts. 
  • Responsible for inspection readiness and, in partnership with Operations, responsible for regulatory inspection outcomes within CSL Plasma.
  • Ensure the quality Group and those with quality leadership responsibilities are educated regarding national and international GMP/blood establishment standards. Regular GMP training is delivered and adapted according to needs and applicable regulations.

Qualifications:

  • Bachelor’s Degree in a related natural science, medical technology, medicine or engineering with post-graduate qualifications.
  • Master’s Degree in Business Administration or Management preferred
  • 10 years of progressively responsible experience in management positions of large, globally dispersed teams in highly regulated, multi-location environments, including direct and indirect leadership of leaders
  • Experienced in a highly regulated healthcare business such as blood or plasma collection, specialized healthcare systems.
  • Strong leadership skills (e.g. priority setting, timely decision-making, development of direct reports and others, business acumen and dealing with ambiguity) and able to make risk based Quality decisions at a senior level. Able to influence and challenge peer groups.
  • Demonstrated ability to lead teams to bring about the compliant resolution of serious issues, at times including disruptions affecting multiple sites, with maturity, excellent communications and deployment skills.
  • Experienced at regulatory inspections – knowledge of FDA, EMA and other country regulations regarding plasma or blood collection.
  • Active in industry groups influencing peer organizations and regulators.
  • Experience in Quality Assurance, or Regulatory Affairs preferred.
  • Significant experience to formulate and implement strategic plans.
  • Experience in understanding industry trends and changes to practice standards so CSL remains an industry leader 
  • Strong organizational, negotiation and influencing skills.
  • Displays strong level of engagement at all levels of the organization and does not only operate at a corporate level
  • Excellent written and verbal communications skills in English.
  • Sound commercial judgment including a demonstrated understanding of the business environment in which CSL operates.  
  • Responsible for P&L

#Plasma #LI-TD1

Job Requirements

 

Job Snapshot

Location US-FL-Boca Raton
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Health Care
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Company Overview

CSL Plasma

CSL Plasma is one of the world’s largest collectors of human plasma and we are committed to excellence and innovation in everything we do. Our work ensures that tens of thousands of people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because people’s lives depend on us. Supported by parent company CSL Behring, the global leader in plasma protein bio-therapeutics, CSL Plasma has more than 120 plus collection centers in the US and Germany, a state-of-the-art testing laboratory that features some of the most advanced technology, instrumentation and automation in the field, two logistics centers and our corporate headquarters in Boca Raton, Florida. Learn More

Contact Information

US-FL-Boca Raton
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Snapshot
CSL Plasma
Company:
US-FL-Boca Raton
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Health Care
Store Type:

Job Description

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!


Job Description

In line with Global Quality strategies, develop and lead the Quality function at CSL Plasma globally. Partners with other executive team members to align the Quality systems with the evolution of the business scope, level of automation and scale of operations, leading the industry in the supply of high quality plasma worldwide. The incumbent in this role is a member of the CSL Plasma Executive Management Team and of the Global Quality Leadership Team. Represents Quality for CSL Plasma globally to internal CSL partners and external strategic partners.

Leadership responsibility for Quality Assurance and Quality Control for collection centers, plasma logistics and release, Supplier Quality Management and Lab QA, ensuring all plasma for further manufacture supplied meets requirements of licensed CSL Behring Product dossiers, and all processes are in compliance with relevant quality standards, regulations, legal and company specific requirements.  In collaboration with CSL Plasma Laboratories and Medical, Operations ensure plasma quality and safety, and donor welfare are reliably suitable and in compliance with relevant Blood Establishment, GLP and GMP regulations globally.

Develop future leaders of CSL through coaching leadership behaviors and skills, development assignments and reinforcement of the CSL values and strengths.

Responsibilities:

  • As a member of the CSL Behring Quality Leadership and Plasma Leadership teams aligns strategic agenda and develops actions to deliver the business outcome with continual focus on improvement and growth.  Leverages global quality program changes for application into the Plasma business line and ensures deployment of industry best practices ok
  • Overall accountability for the quality and compliance of all elements of CSL Plasma, including center operations, distribution centers, and QC laboratories.  Direct the establishment of appropriate quality policies, procedures, infrastructure, capacity, support and training programs to assure the safety and welfare of blood/plasma donors in our collection centers, and the safety and suitability for use of the globally collected or procured plasma for further manufacture.
  • Ensures that all operations are carried out in compliance with local, state and federal regulations, laws and industry standards governing business operations, such as US FDA, US CMS/CLIA, GHA (EMA), Ogyei (EMA), PPTA.
  • Leads plasma quality leaders responsible to manage, motivate and develop professional capabilities of CSL Quality employees (globally) in alignment with business objectives, GxP regulations and industry guidelines. Significant engagement with remote employees is required to be successful.  High dependence on technologically advanced systems for operations, communications and tracking/trending of data, utilizing paperless environments, and cross-site process controls.  Responsible for having the right organizational design and leaders to ensure that the Quality organization can support the growth plans of CSL Plasma. Leads the functional review of performances and merit raises, and the appropriate use of Development plans, especially for high potential employees.
  • Understands external market trends and best practices to actively build understanding of regulator needs and acts collaboratively to influence the evolution of regulations related to our business. Work with industry association(s) as appropriate.  Member of relevant industry associations.
  • Ensures CSL Plasma maintains a Global Quality Management Review process for management oversight and review of Quality performance, including escalation of issues, as appropriate to the Plasma Leadership Team Escalates issues to the Executive Quality Management Review meeting.  
  • Works with peers in the Global Quality Leadership team to develop Quality processes and culture across the CSL Behring network. Works on common initiatives, ensures that the Global Quality Leadership team understand the key regulations, and processes as they relate to plasma collection and contribution of robust quality plasma collection processes on product quality and safety.
  • Develops and manages performance to the annual functional budget designed to meet corporate objectives by review of performance of KPIs such as budget, forecast, cost drivers and audit experience. Periodically, develop forecasts. 
  • Responsible for inspection readiness and, in partnership with Operations, responsible for regulatory inspection outcomes within CSL Plasma.
  • Ensure the quality Group and those with quality leadership responsibilities are educated regarding national and international GMP/blood establishment standards. Regular GMP training is delivered and adapted according to needs and applicable regulations.

Qualifications:

  • Bachelor’s Degree in a related natural science, medical technology, medicine or engineering with post-graduate qualifications.
  • Master’s Degree in Business Administration or Management preferred
  • 10 years of progressively responsible experience in management positions of large, globally dispersed teams in highly regulated, multi-location environments, including direct and indirect leadership of leaders
  • Experienced in a highly regulated healthcare business such as blood or plasma collection, specialized healthcare systems.
  • Strong leadership skills (e.g. priority setting, timely decision-making, development of direct reports and others, business acumen and dealing with ambiguity) and able to make risk based Quality decisions at a senior level. Able to influence and challenge peer groups.
  • Demonstrated ability to lead teams to bring about the compliant resolution of serious issues, at times including disruptions affecting multiple sites, with maturity, excellent communications and deployment skills.
  • Experienced at regulatory inspections – knowledge of FDA, EMA and other country regulations regarding plasma or blood collection.
  • Active in industry groups influencing peer organizations and regulators.
  • Experience in Quality Assurance, or Regulatory Affairs preferred.
  • Significant experience to formulate and implement strategic plans.
  • Experience in understanding industry trends and changes to practice standards so CSL remains an industry leader 
  • Strong organizational, negotiation and influencing skills.
  • Displays strong level of engagement at all levels of the organization and does not only operate at a corporate level
  • Excellent written and verbal communications skills in English.
  • Sound commercial judgment including a demonstrated understanding of the business environment in which CSL operates.  
  • Responsible for P&L

#Plasma #LI-TD1

Job Requirements

 
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