Position Purpose:

Quality Manager - USA:

The Quality Manager - USA serves two primary functions: 1) Support the QMS operations and 2) as the back-up Local Quality Officer (LQO) for the US Vifor Pharma, Inc and CSL Behring Affiliate Operations.

The expected base salary range for this position at hiring is $106,000 - $125,000. 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.

Included in these responsibilities are the day-to-day support of the quality activities within the US Affiliate:

• Support CSL's Quality System and ensure compliance with current local regulations and CSL's global requirements for affiliate operations in the US.
• Support the Product Technical Complaint (PTC) process in the US Market. Assure PTCs are resolved in a timely manner and closed.
• Provide quality support for Warehousing & Logistics, and Customer Service (GDPs) activities.
• Ensure timely final administrative release for domestic products and US Manufactured exported products that represent close to 50% of the entire business revenue for CSLB.
• Manage deviations impacting the release of material and work to quickly resolve issues to limit local and global market impact. Ensure that short- and long-term corrective actions are effectively implemented.
• Serve as a real-time support and interface function for US Commercial Operations, Global Logistics and all Sites of Manufacture.
• Support the Affiliate Recall Coordinator for recalls impacting the US market and support counterfeit product investigations. Liaise with other Global Quality Affiliates operations as needed to ensure relevant information is shared and distributed.
• Collaborates with Global Supplier Quality (GSQ) function to ensure that the established audit program is implemented and executed in a timely manner.
• Work with ESQ to ensure Quality Agreements between the KOP Affiliate, US 3rd Party Logistics and authorized distributors are in place and/or updated as needed.
• Create, review and update Local and Global SOP Quality Procedures and Policies.
• Review and evaluates new or changes to Local GMP/GDP Regulations and assesses impact to current business practices.
• Drive continuous improvement and efficiency initiatives in Global and Local Quality operations of CSL Behring.
• Generate Lot Distribution Report semi-annually as per FDA requirement.
• Maintain the CSLV US Inspection Management program. Schedule and plan regulatory inspection drills to ensure the CSLV US site is ready for any regulatory inspection.
• Limited travel required
• Improve the Global Quality Management System by providing ideas and suggestions to the Quality Systems Operation Teams.

Education:

Requires a bachelor's degree in a relevant business or science discipline.

Experience:

Requires minimum of 5 years of experience as a GMP quality or systems professional in pharmaceutical manufacturing of drug products, medical devices or related field. Experience with Good Distribution Practices (GDP) systems implementation and utilization is desirable. Requires effective communication, collaborative and negotiation skills. Must be comfortable working in a global, matrix organization.

Competencies:

Proven leadership, organizational and interpersonal skills by demonstrating the following competencies:

• Enterprise Results and Value Orientation - Looks for outcomes that maximize the benefits for the Enterprise not just their department or function and pursue value realization for the Enterprise even if their function does not benefit.
• Customer Orientation (external/internal) - Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs. Drives alignment across the Enterprise to customer needs.
• Collaboration & Influencing - Collaborates effectively with others and influences all stakeholders towards Enterprise outcomes, embracing the sometimes difficult conversations needed to deliver Enterprise value.
• Strategic/Innovative - Exhibits global perspective. Takes a global view when approaching issues. Sees ahead to future possibilities & translates to breakthrough strategies. Collaborates to influence strategies of others and adapts own strategy towards global Enterprise Value.
• Change Agent - Mobilizes others to initiate global change; builds group momentum for change; embeds culture of change. Aligns change to Enterprise strategies and direction.
• Analytical and self-motivated. Works independently and with minimum supervision. Excellent oral and written communication skills. Advance computing skills. Experience with SAP is highly beneficial