Quality Manager, USA
About the role
The Quality Manager – USA serves two primary functions: support the QMS operations and act as the back-up Local Quality Officer (LQO) for the US Vifor Pharma, Inc and CSL Behring Affiliate Operations.
Responsibilities
- 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. Ensure 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.
- 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.
- 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 evaluate 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.
Requirements
Requires a bachelor’s degree in a relevant business or science discipline. 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.
Qualifications
Proven leadership, organizational and interpersonal skills by demonstrating the following competencies: Enterprise Results and Value Orientation, Customer Orientation (external/internal), Collaboration & Influencing, Strategic/Innovative, Change Agent, 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.
Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
Pay
The expected base salary range for this position at hiring is $106,000 - $125,000. 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.
Schedule
Implied from the job description, the schedule is likely full-time, but specific details are not provided.