Senior Director Quality Affairs
SurModics, Inc. is a leading provider of surface modification, drug delivery, and in vitro diagnostic technologies to the healthcare industry.
Medical professional with over 25 years’ experience in both clinical and FDA regulated environments, including medical device and pharmaceutical biotechnology. Passionate senior leader with a proven track record of building high performance teams and improving culture. Detailed expertise with Code of Federal Regulations parts 210/211/820, EU MDR, ICH and ISO regulations and standards. Success in process engineering roles, driving process improvements and technical transfers to manufacturing. Significant expertise with aseptic manufacturing, microbiology, and sterilization process validation. Exceptional communication skills and ability to work effectively across departments to execute and drive company goals while balancing business and compliance requirements.
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