Associate Director, Quality Job at CSL Behring
**THIS POSITION REQUIRES THE FLEXIBILITY TO BE ABLE TO TRAVEL UP TO 85% OF THE TIME AS NEEDED
Responsibilities:
- Ensure center processes conform to Quality standards across multiple locations
- Oversee quality metrics and take responsibility for any necessary actions, including but not limited to, a Formal Quality Development Plan to address negative compliance trends
- Oversee the audit process for assigned area, including prep, hosting, and response to audit observations
- Maintain collaboration with Operations partner to meet annual operational, quality and safety goals to ensure that overall quality at all locations is sustained
- Take lead on GXP investigations to ensure root cause, risk mitigation and CAPA are processed correctly and completed
- Manage approval of Quality deviations
- Oversee training and compliance protocols at area locations
- Minimum 7 years management experience, including managing employees,
- Progressive experience handling increasingly responsible positions in a complex organization in a regulated environment (preferred)
- Excellent critical thinking, decision-making and problem solving skills to analyze situations, determine risks and to find solutions to prevent future issues and resolve recurring defects
- Strong organizational skills and attention to detail, multi-tasking, meeting short deadlines and shifting priorities, in support of changing company objectives
- Understanding of regulatory standards, including various local, state and federal laws that apply to the business.
- Experience managing project resources preferred
- Proven skills in budgeting and financial management
- Bachelor’s degree in science/medical technology or equivalent combination of education and relevant work experience
- 5+ years' experience including managing multi-site locations in a regulated industry
- Knowledge of continuous improvement concepts and systems
***Different qualifications or responsibilities may apply based on local legal and/or educational requirements.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Plasma
CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Plasma!
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