Job Purpose:
Quality oversight of the activities for all departments within the assigned Value Stream. This includes operational quality oversight for the area and for the processes, to assure appropriate quality of the products manufactured within the value stream.

Responsibilities:
• Overseeing adherence to any applicable CSL standards and procedures, via 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.
• Oversees all Quality related activities that support within the Value Stream to support the process.
• Partner with all teams within the value stream regarding product quality aspects.
• Responsible for support and oversight of manufacturing shop floor quality, shop floor hygiene / sterility assurance.
• Agency audit participation including assisting in the presentation of quality investigations and decisions to health authorities, leading tours, or acting as backroom support or as a host.
• Maintains a current status for departmental GMP training requirements and provides oversight to onboarding training to department personnel.
• Accountable to manage all batch documentation review per unit operations and issue batch disposition recommendation within deviation investigations.
• Partners with the team to support/review/approval of trends, product technical complaints, investigations, corrective & preventative actions, and change control.
• 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.
• 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.
• 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
• 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.
• Manage and direct the personnel headcount and assist with departmental budget planning.
• Maintain a status for departmental training requirements and provide training to department personnel.
• Responsible for ensuring all deviation events are properly classified, investigated, and given correct final disposition. Responsible for ensuring proper Root Cause Analysis tools are used for investigations resulting in robust corrective and preventive actions. Responsible for review/approval of all high/substantial risk investigations. Oversee environmental investigations that are relative to routine monitoring and/or product monitoring. Responsible for contact with other CSL sites and Global communication regarding investigations and/or changes.
• Drive continuous improvement initiatives and provide quality oversight of change management activities.
• Assists in hosting regulatory agency inspections, as required by Quality Assurance Management.

Qualifications:

Education

• Undergraduate degree in relevant discipline (or equivalent) B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing) or experience and training equivalent to such a degree.

Experience

• Five (5) years industry experience. 1 or more years' experience managing teams directly or in a networked accountability
• 2-3 years' experience supervising two or more staff members preferred. Specific experience in Quality/Change management role preferred. (Proved demonstration to perform min role may also be considered.)

Competencies

• Significant technical expertise in: Change Management/Change control.
• Demonstrated ability to influence decisions, drive continuous improvement, increase value of systems to the business and create an environment of continuous inspection readiness and right-first-time execution.
• Knowledge of cGMPs and regulatory agency guidelines preferred.
• Demonstration competency of verbal and written communication.

The expected base salary range for this position at hiring is $91,000 - $118,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.