LTS Lohmann Therapy Systems, Corp. · 2 days ago
Director Product Quality Operations (PQO)
West St. Paul, MN, US
Full-time
Hybrid
Director/Executive
$140K/yr - $170K/yr
10+ years expLTS Lohmann Therapy Systems is a global leader in transdermal and oral thin-film drug delivery technologies. They are seeking an experienced Director of Product Quality Operations to lead Quality Assurance activities, ensuring product quality and compliance in a highly regulated pharmaceutical environment. The role involves overseeing QA operations, leading a high-performing team, and influencing quality culture within the organization.
Pharmaceuticals
Responsibilities
Lead, develop, and manage QA staff to ensure efficient execution of all quality functions
Oversee employee training programs and onboarding plans
Ensure staffing levels and resources appropriately support business needs
Oversee proper processing and evaluation of deviations, OOS results, investigations, change controls, and complaints
Define and monitor CAPA measures and perform statistical analysis of site-wide quality data
Ensure timely preparation of Product Quality Reviews (PQR/APR) and CPV reports
Review and approve GMP documentation, SOPs, and work instructions
Resolve quality issues, lead investigations, and support cross-functional teams
Serve as a technical leader during customer and regulatory audits
Maintain strong relationships with customer Quality representatives
Ensure each batch is manufactured and tested per applicable regulations prior to release
Release commercial products and intermediates for shipment
Participate in and support global Quality Systems harmonization initiatives
Lead monthly Management Review meetings and support continuous improvement
Qualification
Required
Bachelor's or Master's degree in a scientific field
10+ years of pharmaceutical Quality Assurance experience
At least 5 years leading and developing teams
Strong communication, documentation, and mathematical skills
Advanced proficiency in Word, Excel, and PowerPoint
Knowledge of FDA GMP requirements
Ability to wear PPE including respirators, Tyvek suits, gloves, and other safety equipment
Ability to work in a fast‑paced environment and manage significant change
Up to 10% domestic travel for training and audits
Preferred
Experience with SAP & VEEVA
CDMO experience a plus!
Company
LTS Lohmann Therapy Systems, Corp.
At LTS, our purpose drives everything we do: We CARE for patients, our partners , employees and communities, we CREATE innovative drug delivery solutions, and we DELIVER high-quality products to global markets with an exceptional track record in commercial manufacturing.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase