Global Operational Quality Specialist
Lonza · Greenwood, SC
- Level
- Specialist
- Team
- Quality
- Travel
- 10%
- Experience asked
- 10+ years
- Industry
- Pharma & life sciences
- Posted
- 23 days ago
The role in 30 seconds
A specialist quality role at Lonza (pharma & life sciences) in Greenwood, SC. Develop, implement, and continuously improve global QA/QC standards, corporate SOPs, product release frameworks, control strategies, and quality oversight models.
- They ask for
- 10+ years
- Tools it names
- Root cause, CAPA, FDA / GMP, Validation (IQ/OQ/PQ), Automation
- Day to day
- about 10% travel
Read from the posting. The full description is below.
How this role compares
Against 32 other live quality postings in South Carolina.
- Base pay
- Not listed in this posting
- Experience asked
- More than usual (10+ vs 5+)
Typical $90k–$120k, from 15 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 67%
- FMEA 48%
- SPC 42%
- PPAP 42%
- APQP 36%
- New product launch 36%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for CAPA, FDA / GMP, Automation, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Lonza
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- The posting says about 10% travel. Between which sites?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Lonza in Greenwood
2 other open roles at this site.
- Senior Quality Specialist · Quality · Senior
- Facilities Technician III · Reliability · Technician
Full description from LonzaAs posted on their careers site.ShowHide
What you will do
- ◆Define and maintain the global Quality governance model, including governance structures, KPI/KQI frameworks, reporting processes, and inspection-ready performance management.
- ◆Coordinate global escalation processes, oversee CAPA governance and effectiveness, and drive follow-up of cross-site quality risks, critical quality events, and operational QA/QC issues.
- ◆Define, monitor, and coordinate execution of the Global Quality Plan, Annual Product Reviews, Management Reviews, and strategic quality initiatives aligned with business priorities.
- ◆Develop and drive global Quality Culture and Quality Excellence programs, including communication, best practice sharing, and execution governance across all sites.
- ◆Develop, implement, and continuously improve global QA/QC standards, corporate SOPs, product release frameworks, control strategies, and quality oversight models.
- ◆Drive global harmonization of quality practices through structured gap assessments, implementation follow-up, and inspection-ready quality standards across sites.
- ◆Define, implement, and maintain the global GxP training framework, including governance, curricula, training effectiveness, and Learning Management System processes.
- ◆Support the global coordination of critical quality events by establishing investigation principles, promoting robust root cause analysis, and defining technical expectations for CAPA effectiveness.
- ◆Lead quality change management for global operational quality processes by initiating global changes, performing quality impact assessments, and ensuring cross-site implementation.
- ◆Support business growth by providing QA/QC expertise for strategic initiatives, driving process optimization and digitalization, and embedding continuous improvement into operational quality practices.
Show full description ↓Show less ↑
The Global Operational Quality Specialist coordinates and drives the consistent execution of Operational Quality Assurance/Quality Control (QA/QC) processes across the global network. The role ensures effective implementation of quality governance, standards, performance monitoring, training, and quality systems through cross-functional collaboration with global and site quality teams.
The function supports harmonization of QA/QC practices, coordinates global quality initiatives, monitors execution, and drives timely follow-up of quality actions, risks, and improvement opportunities. The position also facilitates knowledge sharing, strengthens inspection readiness, and promotes sustainable operational quality performance across sites.
What we are looking for
- •MSc in Pharmacy, Biotechnology, (Bio-)Engineering, Life Sciences, or a related scientific or technical discipline.
- •Minimum of 10 years of experience in a GMP-regulated environment, including global quality systems, operational QA/QC, quality governance, and cross-site quality initiatives.
- •Strong technical expertise in GMP, QMS, LIMS, product testing and release, validation, data integrity, inspection readiness, CAPA, change management, and regulatory expectations.
- •Proven ability to develop, harmonize, and implement global quality standards, governance frameworks, and operational quality processes, driving continuous improvement and operational excellence.
- •Strong analytical and digital capabilities, including KPI/KQI development, trend analysis, SharePoint, and digital reporting dashboards and automation tools to support data-driven decision-making.
- •Excellent coordination, stakeholder management, and communication skills, with the ability to influence across global QA, QC, Operations, Validation, and senior leadership while delivering practical, scalable, and sustainable quality solutions
- •Willingness to travel (up to 10%)