Assoc. Director, Quality Value Stream Lead- Bulk

About CSL

With operations in 35+ nations and ~ 22,000 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 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!

Job Description

The key responsibilities of this position are:

This role is responsible for quality oversight of the activities within the manufacturing Value Stream. This includes operational quality management in the area of Bulk/ Fractionation to assure appropriate quality of the products manufactured within the value stream, adherence to any applicable CSL standards and procedures, review and approval of related records, support and approval of quality risk assessments, non-conformances, investigations, CAPAs, and change controls, and monitoring and continuous improvement of quality performance metrics.

1

Manufacturing Value Stream Leadership:

Overall Quality Operations

• Oversees all Quality related activities that support within the Value Stream to support the Bulk/Fractionation process.
• Responsible for product quality and compliance within the site value stream. Partners with all teams within the site value stream regarding product quality aspects
• Responsible for support and oversight of manufacturing shop floor quality, shop floor hygiene / sterility assurance
• Presents quality investigations and decisions to health authorities
• Maintains a current status for departmental GMP training requirements and provides oversight to onboarding training to department personnel.

Batch Operations

• Accountable to manage all batch documentation review per unit operations and issue final batch disposition recommendation

Deviation/Complaint Management

• Partners with the team to support/review/approval of trends, product technical complaints, investigations, corrective & preventative actions, and change control
• Supervises the management of the Product Technical Complaint system and adverse events for the site.
• Management of deviation business process to meet the DIFOT schedule to ensure consistent supply of product to patients.
• Overall management responsibility of deviation investigations ensuring they are properly classified by risk and investigated thoroughly, well written and reviewed/approved in a timely manner. This includes that root cause analysis tools are utilized to drive robust CAPAs

2

Change agent:

• Leads the respective teams to facilitate new ways of working to develop the desired culture within relevant quality areas.
• Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities

3

Leadership:

• Responsible for the management and execution of performance management process. Development of department personnel for Quality Assurance Operations including talent management process.
• Places a high priority on developing others through coaching, feedback and developmental goals.
• Provides a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

4

Network:

• Responsible for representing Quality Assurance Operations on local and global projects and serving on steering committees as required.
• Collaborates and acts as liaison globally with other CSL sites regarding investigation resolution.

5

Health & Safety:

• Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements.
• Reinforces safe working practices with team and champions the safety culture within the site team.

Education:

• Undergraduate degree in relevant discipline (or equivalent)

Related Experience:

• 10 years or more working in a similar role
• Significant experince in:
  • Technical aspects / manufacturing
  • Quality and complinace
  • Batch dispostion
  • Health authority expectations and inspections
• Leadership and influencing skills
• 5 years or more experience working within a global matrix organization
• Involvement in cross-functional, multicultural and international teams

Special Training:

• Ability to work across a range of countries and cultures

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.

Strategic/Innovative:

Global perspective. Takes a broad view when approaching issues. Sees ahead to future possibilities & translates to breakthrough strategies. Collaborates to influence strategies of others, and adapts own strategy towards enterprise value.

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.