The Opportunity
Reporting to the Senior Director, R&D Quality Assurance, you will be responsible for assuring an efficient and compliant end-to-end business process is employed for all GxP-related CMOs, raw material suppliers, service providers, and distributors at all US CSL locations and global for all Pack-n-Label.
The Role
- Implement strategic goals established by functional leadership.
- Performs quality systems audits of approved and/or potential suppliers of raw materials and components, service providers, and distributors, Pack-n-label vendors for the CSL Sites.
- Performs local Site audits, as requested. Represents and articulates Supplier Quality policies and procedures during regulatory audits of local Sites.
- Partner with R&D EU/APAC CMO and Supplier Management counterparts to drive R&D global alignment in audit schedules and overall supplier quality goals for the entire GMP R&D.
- Serves as a point of contact for all supplier quality-related matters or issues. Attends local deviation review meetings and acts as quality liaison between Supplier and Local Site to assist deviation investigation processes. Participates in the change control process as required.
- Identifies and utilizes best-in-class practices for supplier qualification. Establishes appropriate risk management tools, and supplier and raw material monitoring concepts to meet Global and Local supplier quality KPIs.
- Manages the activities of supplier quality agreements for the North American region, which include writing, editing, reviewing, updating, and routing the agreements for approvals between CSL R&D Manufacturing Sites, service providers, and suppliers.
- Works with the Senior Director to support the generation of fiscal year budgetary planning, ongoing forecasting, and business case development to justify year-on-year financial change.
- In collaboration with Global Sourcing, develops supportive and ongoing positive relationships with the external quality functions within CSL’s Critical Suppliers, ESQA, and CMO and Supplier R&D QA EU/APAC.
- Manages overall supplier qualification auditing program including establishment of standardized auditor qualification requirements; on-site, remote, or paper audit determination; and training plans and staff development. Additionally, has responsibility for the R&D supplier audit schedule, approved supplier list, staff alignment, report format, and content requirements.
- Performs additional tasks as may be reasonably assigned in the course of business.
Your skills and experience
- B.S. degree in a relevant business or scientific discipline.
- Minimum of 7 years of experience in a GxP environment in the pharmaceutical industry.
- Strong knowledge of leading internal and external audits and understanding the preparation requirements and entity regulations.
- Must be comfortable working in a global, matrix organization.
- Thorough understanding of required regulations including but not limited to FDA, PIC/s and European regulation, Therapeutics Goods Administration, Canadian Health Authority
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging at CSL.