Product Compliance Manager

2 days ago


GondrecourtleChâteau, Grand Est, United States LTS Lohmann Therapy Systems, Corp. Full time
About LTS Lohmann Therapy Systems, Corp.

LTS Lohmann Therapy Systems, Corp. is a leading Contract Development and Manufacturing Organization (CDMO) that partners with the pharmaceutical industry to deliver innovative oral, transdermal, and intradermal drug delivery systems. Our team of experts is dedicated to utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value, and improve patient outcomes.

Job Summary

We are seeking a highly motivated and detail-oriented 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.

Key Responsibilities
  • 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.
Requirements
  • 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 package
  • Opportunities for professional growth and development
  • A collaborative and supportive work environment
  • The chance to contribute to improving patient lives

LTS Lohmann Therapy Systems, Corp. 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.



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