Lonza · 11 hours ago
QMS Senior Specialist
United States
Full-time
Remote
Senior Level
7+ years expLonza is a global company focused on manufacturing the medicines of tomorrow, and they are seeking a QMS Senior Specialist to enhance their Quality Management System. This role involves leading global governance and continuous improvement of QMS processes, overseeing supplier quality programs, and facilitating collaboration across various functions to advance quality compliance.
BiotechnologyPharmaceuticalLife Science
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
Qualification
Required
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
Preferred
Advanced degree preferred
Lean/Six Sigma certification is a plus
Benefits
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.
Company
Lonza
Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
10001+ employees
H1B Sponsorship
Lonza has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2022 (1)
2021 (3)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$444.8M2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO
Leadership Team
Wolfgang Wienand
Chief Executive Officer
Alfons Ehinger
Founder
Recent News
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