Seasoned, energetic Quality Assurance and Regulatory Affairs professional with 20+ years of experience in pharmaceuticals, medical devices, and combination devices. Expertise in implementing quality management systems including supplier quality and design controls adhering to FDA and EU requirements for pharmaceutical and medical device organizations.
Experience in managing the product development lifecycle from concept to commercialization. Experience in managing production activities for existing products including technology transfers to multiple contract service providers. Demonstrated ability to adapt effectively to the needs of the role and being successful in delivering results.
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