Director of Quality Assurance

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

Lohman Therapy Systems is seeking a highly motivated Director of Quality Assurance to join our growing team. As a premier Contract Development and Manufacturing Organization (CDMO), we are committed to delivering innovative drug delivery solutions to our clients.

This is a full time, hybrid role located in West Caldwell, NJ.

• Role can be remote up to 2 days / week
• On call as needed, occasional travel to Minnesota site.

What You Will Do :

• Ensure regulatory compliance with US FDA, US DEA, and EMA regulations.
• Oversee all site quality operations and the Batch Release Process.
• Manage the site's Annual Product Review (APR) program and Customer Complaint System.
• Serve as a liaison with clients on commercial quality topics.
• Streamline departmental procedures and ensure staff are trained in compliance and efficiency.
• Understand cGMP and ICH guidance to maintain inspection readiness.
• Manage and maintain oversight over all DEA-related activities.
• Participate in global Quality System harmonization activities.
• Generate and maintain site quality system metrics.
• Manage and develop Quality Assurance staff.
• Represent the company for Quality-related issues with customers and internal teams.

Your Background & Qualifications :

• Bachelor's degree in science or related field; Master's degree preferred.
• 10-15 years of experience in a Pharmaceutical or medical device environment in a QA / QC role.
• At least 10 years of experience leading Quality teams.
• Strong organizational leadership skills and ability to influence positively.
• Experience in conducting and hosting GMP Audits.
• Proficiency in Word, Excel, PowerPoint, and SAP.
• VEEVA and SAP experience preferred.

We Offer

• Competitive compensation and benefits package
• Opportunities for professional growth and development
• A collaborative and supportive work environment
• The chance to contribute to improving patient lives

Join our team and make a significant impact on the future of drug delivery.

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.