Director, QC Analytical Technologies

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 Analytical Technologies is accountable for the development and validation of modern QC methods using best practices to support biopharmaceutical manufacturing.

This role will have to manage modernisation needs of routine QC teams on all manufacturing sites and deliver methods for efficient operations. Analytical method validations will have to be performed according to cGMP and presented during authority inspections. The Global QC Analytical Technology team will have staff on all manufacturing sites and support QC operations teams as subject matter experts on all technical QC aspects.

The incumbent will be a member of the Global QC Leadership Team. This role will interact closely with R&D, Engineering and CMOs to support analytical method transfers as sending or receiving site. Working in association with the Director for Process and Standards Excellence the role will support Operational Excellence initiatives through technical and analytical innovation.

The position requires regular travel for onsite presence.

1.Develop and validated modern methods for an efficient QC routine operation

  • Develop the Strategic Plan for Assay Standardization and corresponding Method Development for the QC organisation globally
  • Establish a standardized approach, and oversee, method development plans for each QC site
  • Develop innovative modern QC methods to assure efficient routine operation in the QC labs with a global focus to use best harmonized methods on all manufacturing sites
  • Standardise QC methodology supporting identical products manufactured at various sites
  • Develop and oversee a standardised method validation review for all QC sites globally supporting regulatory body requirements and expectations
  • Identify novel technologies and develop associated implementation strategies designed to improve method performance and customer service delivery
  • Validate analytical methods according to current regulations, best industry practice and global CSL standards
  • Track performance metrics across all manufacturing sites on development projects and report to senior management
  • Establish and maintain processes for test method lifecycle management and monitoring method performance across QC sites

Support transfer of methods from R&D into QC labs or from QC labs to CMOs as subject matter experts.

  • Support global method transfer managers as subject matter expert for sending or receiving analytical methods
  • Establish a close working relationship with Global Owner of Methods Transfer and Validation and R&D labs to represent QC

Support routine QC operation as subject matter experts

  • Provide subject matter expertise on analytical QC methods for trouble shooting and deviation investigations
  • Ensure expertise exchange between the different site QC
  • Support CAPAs for authority inspection observations and regulatory submission as experts on analytical methods

2.Management:

  • Provide leadership and guidance to teams or individuals of scientists on the manufacturing sites performing analytical method development, validations and subject matter expert support
  • Establish performance objectives in a manner that supports the achievement of CSL's business goals and objectives
  • Promotes high employee engagement and a positive work environment
  • Develop staff competencies & capabilities to enable sustained success and career development

Education:

Graduate level in Chemistry, Biochemistry, Microbiology or other related technical field. Masters/PhD degree preferred

Related Experience:

  • 6+ years working experience in Quality Control
  • 10+ years working experience in GMP regulated industry
  • Experience in matrix organizations is required
  • cGMP background in the Pharmaceutical industry and knowledge of relevant GMP regulations (FDA, EU, TGA)
  • Leadership skills in supervision of teams
  • Knowledge of continuous improvement techniques and advanced root cause analysis techniques

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 Analytical Technologies is accountable for the development and validation of modern QC methods using best practices to support biopharmaceutical manufacturing.

This role will have to manage modernisation needs of routine QC teams on all manufacturing sites and deliver methods for efficient operations. Analytical method validations will have to be performed according to cGMP and presented during authority inspections. The Global QC Analytical Technology team will have staff on all manufacturing sites and support QC operations teams as subject matter experts on all technical QC aspects.

The incumbent will be a member of the Global QC Leadership Team. This role will interact closely with R&D, Engineering and CMOs to support analytical method transfers as sending or receiving site. Working in association with the Director for Process and Standards Excellence the role will support Operational Excellence initiatives through technical and analytical innovation.

The position requires regular travel for onsite presence.

1.Develop and validated modern methods for an efficient QC routine operation

  • Develop the Strategic Plan for Assay Standardization and corresponding Method Development for the QC organisation globally
  • Establish a standardized approach, and oversee, method development plans for each QC site
  • Develop innovative modern QC methods to assure efficient routine operation in the QC labs with a global focus to use best harmonized methods on all manufacturing sites
  • Standardise QC methodology supporting identical products manufactured at various sites
  • Develop and oversee a standardised method validation review for all QC sites globally supporting regulatory body requirements and expectations
  • Identify novel technologies and develop associated implementation strategies designed to improve method performance and customer service delivery
  • Validate analytical methods according to current regulations, best industry practice and global CSL standards
  • Track performance metrics across all manufacturing sites on development projects and report to senior management
  • Establish and maintain processes for test method lifecycle management and monitoring method performance across QC sites

Support transfer of methods from R&D into QC labs or from QC labs to CMOs as subject matter experts.

  • Support global method transfer managers as subject matter expert for sending or receiving analytical methods
  • Establish a close working relationship with Global Owner of Methods Transfer and Validation and R&D labs to represent QC

Support routine QC operation as subject matter experts

  • Provide subject matter expertise on analytical QC methods for trouble shooting and deviation investigations
  • Ensure expertise exchange between the different site QC
  • Support CAPAs for authority inspection observations and regulatory submission as experts on analytical methods

2.Management:

  • Provide leadership and guidance to teams or individuals of scientists on the manufacturing sites performing analytical method development, validations and subject matter expert support
  • Establish performance objectives in a manner that supports the achievement of CSL's business goals and objectives
  • Promotes high employee engagement and a positive work environment
  • Develop staff competencies & capabilities to enable sustained success and career development

Education:

Graduate level in Chemistry, Biochemistry, Microbiology or other related technical field. Masters/PhD degree preferred

Related Experience:

  • 6+ years working experience in Quality Control
  • 10+ years working experience in GMP regulated industry
  • Experience in matrix organizations is required
  • cGMP background in the Pharmaceutical industry and knowledge of relevant GMP regulations (FDA, EU, TGA)
  • Leadership skills in supervision of teams
  • Knowledge of continuous improvement techniques and advanced root cause analysis techniques

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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