Meet Melanie Chess
PMP, founder of ChangeWorks
Melanie Chess, PMP, founder of ChangeWorks, brings over 15 years of experience leading business transformation in life sciences, healthcare, and other complex, regulated industries.
With a foundation in laboratory science and regulated manufacturing, she has delivered high-stakes initiatives including post-acquisition integrations, enterprise turnarounds, and system transitions.
Melanie combines strategic insight with hands-on execution, helping businesses turn goals into results without losing momentum. When you work with ChangeWorks, you gain a trusted partner who understands operational complexity, regulatory pressure, and the importance of getting change right the first time.
Key Accomplishments
Manufacturing Relocation: Led the relocation of multiple diagnostic product lines across countries while maintaining Regulatory and ISO compliance, ensuring zero disruption to customer supply and audit readiness throughout.
New Market Entry: Led the stand-up of a new international facility to support expansion into a previously unserved vertical, coordinating global teams and ensuring operational readiness under tight regulatory and timeline constraints.
Regulatory Project Execution: Coordinated pre-inspection readiness for FDA and other regulatory audits at a medical device manufacturing site, translating compliance requirements into clear, actionable workstreams.
Rapid Scale-Up: Quickly transferred a high-value product line, simultaneously scaling production capacity by 10x.
International Restructure: Led cross-functional restructuring of several manufacturing and distribution sites to eliminate silos and improve operational efficiency.
M&A Integration: Supported integration efforts of 40+ acquired businesses, aligning systems, teams, and processes to drive continuity and capture post-deal value.