Reports To: Associate Director Quality Operations Value Stream Lead, Fractionation.

Overview

Responsible for managing Quality Assurance Operations personnel for Parenteral Manufacturing. Responsible for quality oversight of Fractionation Manufacturing Operations.

Key Responsibilities:

• Manage and develop department personnel through performance management.

• Manage and direct the personnel headcount and assist with departmental budget planning.

• Maintain a current status for departmental training requirements and provide training to department personnel.

• Manage the Quality Assurance operations for Fractionation Manufacturing, ensuring that manufacturing operations are performed in a state of Compliance.

• Responsible for ensuring all deviation events are properly classified, investigated, and given the 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 relative to the Parenteral Manufacturing Department.

• Oversee environmental investigations that are relative to routine monitoring and/or product monitoring.

• Prioritize workload according to DIFOT timelines.

• Drive continuous improvement initiatives and provide quality oversight of change management activities.

• Assists in hosting regulatory agency inspections, as required by Quality Assurance Management.

• Maintain a current status for departmental training requirements, and provide training to department personnel.

• Responsible for contact with other CSL sites and Global communication regarding investigations and/or changes.

Education:

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

Experience:

• Minimum of (6) six to (8) eight years of experience working in a cGMP regulated environment such as the field of quality, manufacturing, or engineering, applying the cGMP rules in everyday activities. CFR 211 knowledge is preferred.

• Minimum of (2) two to (3) three years of experience supervising two or more staff members preferred.

• Specific experience in a Quality / Change Management role is preferred.

• Proven demonstration to perform in the role may also be considered.

Qualifications:

• In-depth knowledge of cGMPs.

• Must demonstrate strong leadership qualities, and excellent written and oral communication skills.

• Ability to interpret and apply cGMP and quality principles in daily work, and strong computer/technical skills.

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

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About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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