Associate Director, QC Excellence

CSL


With operations in 35+ nations and ~ 20,000 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 operatesCSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company 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!

The Global Head of QC Excellence is responsible for developing the strategic direction for the Automation and Process Efficiency for the Global Quality Control team. Working in association with the Director for Process and Standards Excellence the role will support Operational Excellence initiatives through technical and analytical innovation.

Under the direction of the Global Head of QC, the role will work with the respective site QC Directors to manage the Automation, Modernisation and IT Interfacing needs for all QC Business Units on all manufacturing sites globally.

The incumbent will be a member of the Global QC Leadership Team. This role will interact closely with the respective site QC Directors, the Global Director for QC Analytical Technology and relevant Engineering heads to support Process Development.

The incumbent will be expected to be connected with providers of automation, process excellence and also emerging technologies.

You will be expected to be experienced with efficient LIMS design and optimal process design. As such you will lead the QC sites to a standardised LIMS design (including Master Data standardisation) based on the adoption of existing best practice, or through implementation of novel best practice (re-engineering).

You are an experienced leader in LEAN process, and subsequent process re-design.

You are an experienced Project Manager and have managed Capital Projects including Business Case Development, Capital Identification, Acquisition Processes (including price negotiation), Implementation and Post Implementation Reviews.

You are familiar with Instrument and IT qualification (validation), and will be responsible for project governance for the introduction of automation

The position requires regular travel for onsite presence

1.Develop and Implement the QC Automation Strategic Plan

  • Develop the Strategic Plan for the Global QC organization designed to drive Process Standardization, Automation, Best Practice IT design and Process Efficiency.
  • Establish and Implement processes to identify areas for greatest benefit from Automation. Process Re-Design or IT interface- including Equipment/Automation options
  • Develop and Implement a standard Business Case approach to support Capital approval submissions
  • Establish Project Milestones and associated metrics to monitor achievement of the plan and address areas of poor compliance to the plan
  • Establish and Implement post Implementation Reviews (PIR's) to ensure the identified benefits of the Business Plan have been delivered
  • Review Site Manufacturing Development Plans to ensure appropriate QC support is provided

Provide Site Leadership with Global Vision

  • Actively participate as part of the Global QC Leadership team
  • Working with the Global Head for Analytical Technology and the Global QC Directors, support and implement the associated strategies for performance improvement and standardisation
  • Provide active support to the other Global QC Directors for non-project based process improvement

Key Job Achievables.

  • Accountable for the automation in the QC labs. Develops strategies and implement automation solutions for the instrument – LIMS interface
  • Accountable for the lab instrument qualification including interaction with Engineering. Instrument maintenance and support on the sites
  • Accountable for LIMS master data management and coordination of LIMS projects with QC and BT
  • Lead for standardization of processes
  • Develop lean and paperless lab processes
  • Establish a customer focused and supportive culture across the QC Business Unit to facilitate efficient communication channels

2.Personal

  • Ability to influence and communicate to senior management, peers and QC teams to drive efficient processes and systems
  • Lead by example in the display of company values and assume responsibility for ensuring these values are operational within the Business Unit
  • Provide leadership and guidance to project teams or individuals of scientists on the manufacturing sites to achieve project deliverables

Education:

  • Graduate level in Chemistry, Biochemistry, Microbiology or other related technical field. Masters/PhD degree preferred
  • Qualification in Business Management an advantage
  • Qualification in Project Management an advantage
  • Qualification in LEAN, Six Sigma an advantage

Related Experience:

  • 6+ years working experience in Quality Control
  • cGMP background in the Pharmaceutical industry and knowledge of relevant GMP regulations (FDA, EU, TGA)
  • Previous experience in Capital related Project Management
  • Previous experience in Process Re-Engineering and Automation
  • Previous experience with LIMS design and Implementation.
  • Knowledge of continuous improvement techniques (LEAN)

Special Training:

  • Fluency in English
  • Knowledge of pharmaceutical industry standards through active engagement in industry associations, e.g. PDA, ISPE
  • Lean and Six-sigma training are a plus
  • Strong communication, negotiation and conflict management skills to influence technical experts and stakeholders at all levels in the organization
  • Ability to influence and motivate others while maintaining a cohesive team environment.

Competencies:

Customer Orientation (Internal/External):
Creates companywide strategies to stay ahead of industry-related changes. Drives alignment across the enterprise in order to serve customer needs. Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs.

Enterprise Results and Value Orientation:
Looks for outcomes that maximize the benefits for the enterprise, not just their department or function. Pursues value realization for the enterprise even if their function does not benefit.

Collaboration and Influencing:
Champions a culture of inclusiveness and teamwork.
Collaborates effectively with others and influences all stakeholders towards enterprise outcomes. Embraces conversations needed to deliver enterprise value.

Priority Setting:
Spends his/her time and the time of others on what's important; quickly zeros in on the critical few and puts the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.

Change Management:
Mobilizes others to initiate change; builds group momentum for change; embeds culture of change. Aligns change to enterprise strategies and direction.

Interpersonal Savvy:
Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

Worker Type:

Employee

Worker Sub Type:

Regular

CSL


With operations in 35+ nations and ~ 20,000 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 operatesCSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company 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!

The Global Head of QC Excellence is responsible for developing the strategic direction for the Automation and Process Efficiency for the Global Quality Control team. Working in association with the Director for Process and Standards Excellence the role will support Operational Excellence initiatives through technical and analytical innovation.

Under the direction of the Global Head of QC, the role will work with the respective site QC Directors to manage the Automation, Modernisation and IT Interfacing needs for all QC Business Units on all manufacturing sites globally.

The incumbent will be a member of the Global QC Leadership Team. This role will interact closely with the respective site QC Directors, the Global Director for QC Analytical Technology and relevant Engineering heads to support Process Development.

The incumbent will be expected to be connected with providers of automation, process excellence and also emerging technologies.

You will be expected to be experienced with efficient LIMS design and optimal process design. As such you will lead the QC sites to a standardised LIMS design (including Master Data standardisation) based on the adoption of existing best practice, or through implementation of novel best practice (re-engineering).

You are an experienced leader in LEAN process, and subsequent process re-design.

You are an experienced Project Manager and have managed Capital Projects including Business Case Development, Capital Identification, Acquisition Processes (including price negotiation), Implementation and Post Implementation Reviews.

You are familiar with Instrument and IT qualification (validation), and will be responsible for project governance for the introduction of automation

The position requires regular travel for onsite presence

1.Develop and Implement the QC Automation Strategic Plan

  • Develop the Strategic Plan for the Global QC organization designed to drive Process Standardization, Automation, Best Practice IT design and Process Efficiency.
  • Establish and Implement processes to identify areas for greatest benefit from Automation. Process Re-Design or IT interface- including Equipment/Automation options
  • Develop and Implement a standard Business Case approach to support Capital approval submissions
  • Establish Project Milestones and associated metrics to monitor achievement of the plan and address areas of poor compliance to the plan
  • Establish and Implement post Implementation Reviews (PIR's) to ensure the identified benefits of the Business Plan have been delivered
  • Review Site Manufacturing Development Plans to ensure appropriate QC support is provided

Provide Site Leadership with Global Vision

  • Actively participate as part of the Global QC Leadership team
  • Working with the Global Head for Analytical Technology and the Global QC Directors, support and implement the associated strategies for performance improvement and standardisation
  • Provide active support to the other Global QC Directors for non-project based process improvement

Key Job Achievables.

  • Accountable for the automation in the QC labs. Develops strategies and implement automation solutions for the instrument – LIMS interface
  • Accountable for the lab instrument qualification including interaction with Engineering. Instrument maintenance and support on the sites
  • Accountable for LIMS master data management and coordination of LIMS projects with QC and BT
  • Lead for standardization of processes
  • Develop lean and paperless lab processes
  • Establish a customer focused and supportive culture across the QC Business Unit to facilitate efficient communication channels

2.Personal

  • Ability to influence and communicate to senior management, peers and QC teams to drive efficient processes and systems
  • Lead by example in the display of company values and assume responsibility for ensuring these values are operational within the Business Unit
  • Provide leadership and guidance to project teams or individuals of scientists on the manufacturing sites to achieve project deliverables

Education:

  • Graduate level in Chemistry, Biochemistry, Microbiology or other related technical field. Masters/PhD degree preferred
  • Qualification in Business Management an advantage
  • Qualification in Project Management an advantage
  • Qualification in LEAN, Six Sigma an advantage

Related Experience:

  • 6+ years working experience in Quality Control
  • cGMP background in the Pharmaceutical industry and knowledge of relevant GMP regulations (FDA, EU, TGA)
  • Previous experience in Capital related Project Management
  • Previous experience in Process Re-Engineering and Automation
  • Previous experience with LIMS design and Implementation.
  • Knowledge of continuous improvement techniques (LEAN)

Special Training:

  • Fluency in English
  • Knowledge of pharmaceutical industry standards through active engagement in industry associations, e.g. PDA, ISPE
  • Lean and Six-sigma training are a plus
  • Strong communication, negotiation and conflict management skills to influence technical experts and stakeholders at all levels in the organization
  • Ability to influence and motivate others while maintaining a cohesive team environment.

Competencies:

Customer Orientation (Internal/External):
Creates companywide strategies to stay ahead of industry-related changes. Drives alignment across the enterprise in order to serve customer needs. Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs.

Enterprise Results and Value Orientation:
Looks for outcomes that maximize the benefits for the enterprise, not just their department or function. Pursues value realization for the enterprise even if their function does not benefit.

Collaboration and Influencing:
Champions a culture of inclusiveness and teamwork.
Collaborates effectively with others and influences all stakeholders towards enterprise outcomes. Embraces conversations needed to deliver enterprise value.

Priority Setting:
Spends his/her time and the time of others on what's important; quickly zeros in on the critical few and puts the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.

Change Management:
Mobilizes others to initiate change; builds group momentum for change; embeds culture of change. Aligns change to enterprise strategies and direction.

Interpersonal Savvy:
Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

Worker Type:

Employee

Worker Sub Type:

Regular

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