Senior Quality Program Specialist
LonzaMaryland, United States
Posted January 30, 2026
95000 - 153000 USD
Full Time
About the Company
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow.
Job Description
We are looking for a Senior Quality Program Specialist to ensure company compliance with ISO and cGMP quality system requirements and applicable regulatory guidance. The ideal candidate provides independent quality oversight and plays a key role in audits, inspections, continuous improvement initiatives, and quality system governance.
Requirements
- 7+ years of relevant work experience in Quality Assurance, validation, quality systems, or regulated biopharmaceutical/manufacturing environments.
- Bachelor’s degree (BS) in a scientific, engineering, or related technical discipline
- Strong technical writing, review, and documentation skills
- Extensive knowledge of cGMPs, ISO standards, FDA regulations, and Quality Unit requirements
- Demonstrated expertise in Computer system validation & Equipment qualification
- Ability to independently review and approve validation protocols and reports
- Proficiency with MS Office tools (Word, Excel, Adobe, Visio)
- Experience with Quality Systems such as Document Management Systems and TrackWise QMS
Benefits
- Performance-related bonus
- Medical, dental and vision insurance
- 401(k) matching plan
- Life insurance, as well as short-term and long-term disability insurance
- Employee assistance programs
- Paid time off (PTO)
