Ken Howerton serves as the Vice President of Quality Operations at Alnylam Pharmaceuticals, where he leverages over 25 years of extensive experience in biopharmaceutical operations and quality systems. In this pivotal role, Ken is responsible for overseeing all Good Manufacturing Practice (GMP) operations, including Quality...
Ken Howerton serves as the Vice President of Quality Operations at Alnylam Pharmaceuticals, where he leverages over 25 years of extensive experience in biopharmaceutical operations and quality systems. In this pivotal role, Ken is responsible for overseeing all Good Manufacturing Practice (GMP) operations, including Quality Assurance (QA) and Quality Control (QC), which are critical for ensuring the integrity and compliance of both clinical and commercial supply chains. His leadership is instrumental in fostering a culture of quality and continuous improvement across the organization, aligning with regulatory standards set forth by the FDA and other governing bodies.
Ken's expertise spans a wide array of essential functions within the pharmaceutical industry, including purification processes, cleaning validation, and computer system validation. His comprehensive understanding of GxP (Good Practice) regulations and ISO standards enables him to build robust quality organizations across multiple sites, ensuring that all operations meet the highest standards of safety and efficacy. Currently, he is spearheading key projects aimed at enhancing operational efficiencies and streamlining quality processes, which are vital for maintaining Alnylam's commitment to delivering innovative therapies.
In addition to his technical acumen, Ken is a champion of cross-functional collaboration, working closely with R&D, manufacturing, and regulatory teams to drive quality initiatives that support the company’s strategic goals. His dedication to excellence and his proactive approach to quality management not only safeguard patient safety but also bolster Alnylam's reputation as a leader in the biopharmaceutical sector.
