, , , ,

monaco-irma-2065213Title: Quality Operations Manager

Company: EMD Serono, Inc

Location: Hamilton, Ontario, Canada


Hamilton, Ontario, Canada, December 16, 2016, Irma Monaco, Quality Operations Manager of EMD Serono, Inc, has been recognized by Elite Women Worldwide, for dedication, achievement and leadership in biopharmaceuticals.

Ms. Monaco has nearly two decades of pharmaceutical experience in the areas of submissions management and medical services. Her technical and analytical expertise covers a wide spectrum of pharmaceuticals, biologics, devices and over-the-counter products. In addition, she has ensured that chemistry data, including submission data generated by the laboratory and process validation, complies with standard operating procedures and good manufacturing practice.

Looking back, Ms. Monaco attributes her success to her passion, patience and ability to connect with others. She became involved in her profession after graduation, when she interviewed with a firm that was being purchased by a larger company whose regulatory team was leaving. The head of regulatory services invited her to join her in a consulting role where Ms. Monaco helped build a team from five to 100 people. Her contribution to the growth and success of the different pharmaceutical organizations she has worked for has been the highlight of her career.

Ms. Monaco received a Bachelor of Science and became a certified pharmacy technician through Niagara College in 1995. In years to come, Ms. Monaco sees herself working with the key stakeholders in developing robust strategies to reduce the time it takes for a drug to reach the market, and hence, contributing to patient safety and a company’s success. Furthermore, she plans on assisting up-and-coming regulatory professionals in developing the correct approach to building relationships, thus maximizing the cost-effective use of company resources and coordinating scientific endeavors with regulatory demands throughout the life cycle of the product.

Contact Irma Monaco