About LTS: LTS Lohmann Therapy Systems is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems.
From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners' market advantage.
Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes.
We Care.
We Create.
We Deliver.
Job Summary Lohmann Therapy Systems North America is seeking a dynamic Product Compliance Manager/Sr.
Product Compliance Manager to join our team.
As a key member of our organization, you will oversee the day-to-day operations of our compliance systems, investigations, CAPAs, and batch record review.
You will also play a vital role in supporting internal and external audits and complaint management.
This is a full-time, on-site role located in West St. Paul, MN What You Will Do: Ensure adherence to cGMP, FDA, and DEA regulatory standards.Manage the investigation process, CAPA, complaints, and environmental programs.Drive thorough investigations, identify root causes, and implement effective CAPAs.Oversee timely completion of batch record review and deviation closures.Provide leadership to improve quality systems and support GMPs and manufacturing processes.Develop predictive metrics and KPIs from audits, investigations, complaints, and CAPAs.Represent the quality assurance department on cross-functional project teams.Review and approve IT change controls, validation protocols, and reports.Manage a team of QA Specialists and QA Inspectors, providing workload allocation, objective setting, and performance reviews.Your Background: Bachelor's degree in science.10-14 years of experience in the pharmaceutical field.Knowledge of cGMP, USP, EP, and CFR requirements.Experience with SAP and Veeva systems.Excellent reading, writing, and verbal skills.Intermediate or advanced proficiency in Word, Excel, and PowerPoint.Strong mathematical skills.Proven team-player mentality.Previous management experience.Ability to wear safety equipment as needed.Ability to work in a fast-paced environment and adapt to change.We Offer Competitive compensation and benefits packageOpportunities for professional growth and developmentA collaborative and supportive work environmentThe chance to contribute to improving patient livesIf you are a highly motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply. LTS is an equal opportunity employer.
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.