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 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!

Associate Director, Quality Engineering Lead - Commissioning & Qualification (f/m/d)

Reporting into the Senior Director Quality Engineering, the Leader, Quality Engineering Commissioning & Qualification will be responsible for the Quality oversight for Commissioning & Qualification activities. The individual will be accountable for process and product quality of commercial products and of Capex projects of a manufacturing site.

• The incumbent will have demonstrated strong technical knowledge in the above areas Commissioning & Qualification and cGMP compliance. They will be experienced in regulatory strategies and submissions for new products and technology transfers and have experience in associated regulatory inspections. They will be responsible for QA oversight of quality standards and systems aligned with the Engineering function in the above areas.

• This role will be responsible for the following: System Verification/
  commissioning, Risk analysis, IQ/OQ/PQ, CSV (responsibility of Business Technology within QA Compliance & Systems), Re-qualification, SOPs & training, Deviation (oversight), Changes, Inspections

• The incumbent will implement a learning culture and will ensure a vertical and horizontal knowledge management

The incumbent will be the Quality partner to the teams within of Global Engineering and work closely with members of the Global Engineering peers of the corresponding teams as well as Process Engineering. S/he will be also partner to the corresponding Value Stream QA Team Leaders.

The incumbent will work closely with his or her peers in Quality Engineering from the other manufacturing sites and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites and that in all projects the appearance of the documentation in the stated areas is standardized.

The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.

Provide Quality Assurance Oversight including issue and Risk Management for local capital investment projects in area of responsibility (Commissioning & Qualification).

• Collaborate with internal partners for the execution of all capital projects - EU and US and others - to deliver projects on time and to the required standards and regulatory requirements.
• Provide a consistent quality approach to facility, equipment and process design and development for capital projects
• Responsible for Quality decisions for capital projects in area of consultation with global Engineering and local QA Operations leaders.
• Provide QA oversight on equipment across the entire capital project.
• Support regulatory document submissions and pre-approval inspections for capital projects.
• Provide leadership to the capital project team to deliver "on time" and compliant delivery of activities in accordance of the approved project schedules

Provide Quality Assurance Oversight including issue and Risk Management, for Commissioning & Qualification

• Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of all Commissioning & Qualification activities to deliver these changes on time and to the required standards.
• Provide support to Quality Oversight of the corresponding other local QA Engineering function and support to the other sites commissioning and qualification, activities.
• Partner to ensure Quality decisions regarding Commissioning & Qualification activities are aligned with the direction of the organization.
• Supports Global Engineering in performing risk analysis's
• Contributes to the review and approval of all user requirements, protocols and reports linked to commissioning and qualification activates.
• Builds together with Global Engineering the framework for routine maintenance activities and frequencies
• Ensures quality is represented appropriately for regulatory document submissions and regulatory inspections for technical transfer and the corresponding activities
• Lead quality aspects of risk assessments for product quality and compliance and escalate and mitigate risks appropriately.

Provide Quality Assurance Oversight for Engineering Standards & Engineering Documentation and Knowledge Management in Commissioning & Qualification

• Ensures appropriate development, implementation and maintenance of global engineering standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures and work instructions). Approves the documents.
• Collaborates with engineering on the set up and maintenance of an appropriate Documentation and Knowledge Management system for the Engineering function.
• Responsible for the approval of the documentation in the above areas, ensure compliance to GMP and that required standards are met. Ensure a harmonized appearance of all documentation across the entire capital project.
• Ensure that global standards are met for user requirements Commissioning & Qualification
• Participate in deviations, SQUIPP assessment, ensure compliance of the final deviation reports.
• Provide QA oversight if acceptance criteria were not met.
• Facilitate global and local change controls
• Provide QA oversight to Quality Risk Assessments and manage quality risk strategy
• Contribute to internal and authority pre- and post-approval inspections
• Provide QA oversight to APQR/PQR Follow up actions.

If team lead function is included (depends on size and complexity):

Provide local Engineering Quality team leadership

• Lead the global Quality Engineering team
• Provide leadership and guidance to a local team of Engineering Quality professionals
• Set objectives and provide clear direction for execution.
• Responsible for organizational design and staffing decisions.
• Recruit, retain, train and develop the local Engineering Quality team.
• Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.

Qualifications:
• Degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred
• 8-10 years' experience in quality/GMP in the pharmaceutical/biotech industry including 3+ years' leadership/team management experience
• Experience with regulatory authorities and international inspections
• Demonstrated success in project management and business/QA systems
• Experience within a global matrix organization
• Knowledge of appropriate regulatory requirements including GMP/GQP

Worker Type:
Employee

Worker Sub Type:
Regular