QMS Senior Specialist

Lonza•Greenwood, SC

9d•Remote

About The Position

As a key member of our global Quality Organization, the QMS Senior Specialist will help shape and elevate the maturity of our global Quality Management System (QMS). This role is ideal for someone who thrives in a highly collaborative, multi‑site environment and wants to drive global impact in quality, compliance, and continuous improvement. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. A variety of benefits dependent on role and location. Explore more of our benefits here: https://www.lonza.com/careers/benefits.

Requirements

7–10+ years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance within pharmaceutical, food, or healthcare environments required.
Direct, hands‑on QMS experience within Drug Product manufacturing (required — current or past experience acceptable).
Strong expertise in QMS frameworks and regulatory standards (GMP, GxP, ISO, HACCP), with experience supporting inspections and audits.
Proven ability to lead global or multi‑site quality initiatives, including corporate‑level auditing and cross‑functional program management.
Strong analytical, digital, and data skills, with experience using MS Office, Power BI, SharePoint, SAP, and QMS platforms.
Excellent communication and stakeholder‑engagement skills across regions, functions, and leadership levels.
Bachelor’s degree in a scientific or technical discipline required

Nice To Haves

Advanced degree preferred.
Lean/Six Sigma certification is a plus.

Responsibilities

Lead global governance, harmonization, and continuous improvement of QMS processes aligned with GMP, GxP, ISO, and regulatory expectations.
Co‑develop and manage global inspection‑readiness programs, including corporate audits and pre‑/post‑inspection support across sites and functions.
Oversee raw material and supplier quality programs, including audits, compliance assessments, and maintenance of technical relationships with global suppliers.
Serve as a global SME for core QMS processes (document control, change control, CAPA, risk management) and support digital QMS platform optimization.
Lead global certification and recertification activities (ISO, GMP, HACCP) and coordinate readiness with certification bodies.
Support global quality initiatives, including QMS integrations, system transitions, and cross‑division improvement projects.
Facilitate collaboration across regions, sites, and corporate functions to advance QMS maturity and compliance culture.