Lonza · 13 hours ago
Senior Quality Program Specialist
Walkersville, MD
Full-time
Onsite
Mid, Senior Level
$95K/yr - $153K/yr
7+ years expLonza is a global leader in life sciences manufacturing. The Senior Quality Program Specialist is responsible for ensuring compliance with ISO and cGMP quality system requirements while providing oversight and support to operations and quality control teams.
BiotechnologyLife SciencePharmaceutical
Responsibilities
Verify and maintain compliance with ISO and cGMP quality system requirements
Serve as QA Subject Matter Expert (SME) for validation, equipment qualification, facilities, and associated quality systems
Review and approve qualification and validation protocols and reports
Provide QA oversight for cleaning validation, equipment calibration and maintenance, OOTs, periodic reviews, and related documentation
Provide real-time quality support to Operations and Quality Control teams to address compliance-related issues
Make independent quality decisions based on regulatory and compliance expertise
Provide oversight and approval of CAPAs, deviations, investigations, OOTs, and change control records
Perform quality system activities within DMS, LIMS, and TrackWise (Change Control, CAPA, Deviations, Investigations)
Act as a customer and regulatory interface during audits, inspections, and meetings
Represent the QA department in internal and external audits and regulatory inspections
Support documentation updates, quality projects, and continuous improvement initiatives
Lead or support gap analyses, mitigation plans, and ad hoc quality improvement projects
Maintain site compliance with approved quality systems, regulatory requirements, industry standards, and customer expectations
Perform other duties as assigned
Qualification
Required
Minimum of 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 is required
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
Strong working knowledge of manufacturing quality systems (manufacturing, packaging, facilities, critical systems, validation)
Proficiency with MS Office tools (Word, Excel, Adobe, Visio)
Experience with Quality Systems such as Document Management Systems and TrackWise QMS
Proven ability to manage multiple priorities in a fast-paced environment
Strong project planning, execution, and collaboration skills
Proactive, innovative, and resourceful mindset with a focus on continuous improvement
Ability to guide, coach, and mentor others while fostering a strong Quality Culture
Highly self-accountable with the ability to meet deadlines or proactively communicate and resolve obstacles
Preferred
Experience interacting with FDA or other regulatory agencies is strongly preferred
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).
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
NH Business Review
2026-01-17
Company data provided by crunchbase