RD

Rene Dewald

QA Manager at Lannett

Rene DeWald has a diverse work experience spanning several industries and roles. They started their career as a Forensic Chemist at the Cape May Courthouse Prosecutor's Office, where they analyzed crime scene samples, controlled substances, and testified in court. Following that, they worked at Whitehall-Robins for 15 years in various positions.

In 1996, Rene joined URL Mutual Pharmaceuticals Inc. as a Senior Manager in Compliance and QA. They played a crucial role in implementing a compliant Quality System for the release of clinical supply materials. They also approved process validation protocols and reports, annual product reviews and reports, and managed the Compliance Unit. Rene's expertise in microbiological testing, audits, and change control contributed to the company's compliance and business goals.

After their tenure at URL Mutual, Rene held Director-level positions in QA and RA at several companies, including Comar Contract Packaging, Pharmaceutical Outsource Packaging, and ARC National Testing Laboratories. They were responsible for hosting customer audits and FDA inspections, developing and implementing quality systems, and managing quality units.

At Stada Pharmaceuticals Inc. US, Rene served as a Project Manager and Senior Regulatory Affairs Associate. They successfully developed and managed new products and BD project plans, adhering to FDA regulations.

Rene's next position at Cardinal Health as the Director of Quality Operations allowed them to focus on implementing a risk-based quality systems approach. They provided a strategic roadmap and benchmarking for the Operations Department, enhancing compliance and functionality.

During their tenure at Tunnell Consulting Inc., Rene worked as a Senior Consultant, providing regulatory affairs and quality assurance services to a Clinical Services organization.

Most recently, Rene worked as the QA Manager at Lannett Co. Inc. Their responsibilities in this role are not specified in the given information.

Overall, Rene DeWald's work experience showcases their expertise in quality assurance and regulatory affairs, project management, and their ability to implement compliant systems and achieve business goals.

Rene DeWald pursued their education at Cabrini University from 1976 to 1980, where they obtained a Bachelor of Science degree in Chemistry and Mathematics.

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