Director, Quality Assurance - Pharmaceutical Manufacturing

LTS Lohmann Therapy•West St. Paul, MN

1d•Hybrid

About The Position

LTS is seeking an experienced Director of Quality Assurance to lead Quality Assurance activities at our St. Paul, MN site. This is a critical leadership role responsible for ensuring product quality, driving compliance, and shaping Quality strategy in a highly regulated pharmaceutical environment. You will oversee end‑to‑end QA operations—from deviations, investigations, and CAPAs to batch record review, product release, and global Quality Systems harmonization. You will lead a high‑performing QA team, partner closely with site leadership, and serve as a key technical expert during audits and regulatory interactions. This is an opportunity to influence quality culture, elevate operational performance, and contribute to the delivery of life‑changing therapies. This is a full time, hybrid role located in West St. Paul MN. Hybrid potential after initial probationally period, up to 2 days/week

Requirements

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.

Nice To Haves

Experience with SAP & VEEVA
CDMO experience a plus!

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.