Job Detail

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!

Stellenbeschreibung

The key responsibilities of this position are: - Timely supply of products to the appropriate quality standards from CSL Behring manufacturing sites - Quality KPI delivery, and continuous improvement, for CSL Behring manufacturing sites, including efficiency metrics. - Successful regulatory inspections and relationships with the appropriate Health Authorities for manufacturing sites - Ensure a strong and consistent Quality culture in partnership with Manufacturing & Engineering in the End to End operational structure - Management review, escalations and improvement plans for Quality risks and issues for CSL Behring Manufacturing sites - Implementation of standardized operational Quality processes for Quality Assurance aligned with the Quality Strategic Plan - Ensuring consistency product Quality attributes for CSL Behring products across the network, including growth projects at each manufacturing site. - Development of a cohesive Quality Operational Leadership Team for the manufacturing sites, operating to consistent standards - Implement standardized organizational structures for Quality across all Manufacturing sites - Budgetary control and productivity improvements for CSL Behring Manufacturing Sites - Succession planning and talent development for site based Quality roles and the Quality enterprise function. - Key member of the CSL Behring Quality Leadership Team. Influencer at senior levels within CSL Behring. This role will also be a member of the Operations Council.

Principal Accountabilities: 

1. Responsible for Quality oversight for the manufacture of pharmaceutical products in line with internal and external regulatory standards across the CSL Behring manufacturing site network. To ensure consistent product quality attributes across the manufacturing sites.

2. Maintain positive relationships with regulatory Health Authorities and ensure successful GMP inspection outcomes. Good knowledge of changing regulations and trends in the regulatory and Quality environments. 3. Management Review and Oversight of Quality Risks within the manufacturing site network, and implementation of improvement plans. Escalation of risks, and mitigations, to Global Head of Quality and the Global Head of Manufacturing.

4. Development of standardized processes and ways of working across all sites for Quality Assurance. Partners with the Global Head of Manufacturing and Site Heads, to deliver Right First Time, standardized and efficient CSL Behring QA operations, including 24/7 shop floor quality partnerships.

5. Set and meet Quality KPI targets across the manufacturing network to and continuously improve KPI performance year on year. Identification and delivery of improvement projects for productivity efficiencies within Quality Assurance.

6. Ensuring consistency of manufacturing processes and product Quality attributes for CSL Behring products across the network, including growth projects at each manufacturing site.

7. Develops and leads a cohesive team of Site Quality Heads responsible for consistent standards, ways of working and quality culture across the manufacturing network. Implement efficient and standardized organizational structures for Quality Assurance across all Manufacturing sites. Responsible for the site’s Quality talent development and succession planning. Coach and mentor for key talent.

8.Sets and delivers Quality budgets and targets for the manufacturing sites.

9. Key member and influencer in CSL Behring Quality Leadership Team. Partners closely with senior leaders in CSL Plasma Quality and Affiliate Quality to achieve Quality Excellence across all parts of the operation. Deputises for Head of Global Quality, when required.

Member of the Operations Council.

Education:

• Requires a degree in biological, medical, or pharmaceutical sciences or related field (i.e. engineering).


• A Masters or Doctorate degree preferred.

Related Experience:

• Minimum of 15 years’ experience in a pharmaceutical or biopharmaceutical company/ies in roles with increasing responsibility in quality or operations management.


• Experience as a Site Head of Quality desired, or senior Quality role.


• Minimum 10 years of managerial experience 


• Experience in preparing and complying with required regulatory guidelines including inspection readiness and follow-up. Extensive dialogue and discussion with regulatory health authorities.


• Skilled at Quality risk based decision making and able to transfer these skills into team


• Strong operations background to ensure value added and effective quality operations in partnership with Manufacturing. Experience driving out inefficiencies and improving cycle times.


• Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills


• Ability to build, mentor and grow a high performing and cohesive team of Site Quality Heads and Operational Leaders.

Special Training:

• Preference for experience in biologics and/or biotechnology, including sterile products


• Ability to work across a range of countries and cultures


• Implementation of a standardized practices across a number of manufacturing sites

Competencies: Proven leadership, organizational and interpersonal skills by demonstrating the following competencies at the enterprise level:

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.

#LI-TD1 #behring