Responsibilities

• Ensure center is “inspection ready” at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center.
• Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management.

• Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination.

• Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of timely audits. Utilize quality tools and applications to facilitate understanding of issues and documentation.

Experience

• Bachelor degree in scientific discipline/life sciences or related discipline
• 5+ years' experience related to quality and regulatory/ Plasma industry experience
• Demonstrated leadership/supervisory experience
• Knowledge of government and industry regulations

Preferred dress code

Business Casual or Scrubs

About CSL Plasma

See yourself at CSL Plasma...opportunities for you to pursue meaningful work, realize your potential, and grow your career.

Health, Well-being, and Security
Medical, Dental, and Vision Insurance
Accidental Death & Dismemberment Insurance (AD&D)
Life Insurance
Dependent Life
Short-Term and Long-Term Disability
Financial Planning
Company Paid Holidays

Time Away from Work
Paid Time Off
Paid Floating Holidays
Bereavement Days
Personal, Medical, and Military Leave

Your Future
401(K) Savings Plan
Tuition Reimbursement
Global Employee Share Plan
Career & Development

What is a virtual interview?

Virtual interviews help employers connect with job seekers when they are not in the same physical location. Since hiring is a human process, employers would like to talk with you online (chat, video or phone) to see if you meet the requirements for the job.