What are the responsibilities and job description for the VP Quality & Regulatory Affairs position at LTS Lohmann Therapy?
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:
This is a full time, hybrid located in West St. Paul MN or West Caldwell, NJ. Ideal candidates will be in driving distance of these locations.- Regular travel between the two locations is required.
What You Will Do:
- Ensure LTS NA compliance with FDA, DEA, and ICH regulations.
- Harmonize quality systems across North American manufacturing sites and with global LTS systems.
- Interact with regulatory agencies (e.g., FDA, EMA).
- Oversee timely delivery of QC, QA, QTS, and regulatory commitments.
- Lead and develop a multi-site team, including direct management of managers.
- Develop and mentor staff with clear goals and objectives.
- Establish and monitor Quality KPIs for trends and compliance.
- Provide executive leadership to support business strategy and objectives.
- Evaluate and implement customer-recommended quality system improvements.
- Reorganize or replace staff as needed to maintain team effectiveness and morale.
- Promote accountability and hold staff responsible for performance.
- Ensure department operations are efficient and effective.
- Make sound, timely decisions.
- Ensure laboratory assets meet business needs in terms of capacity and capability.
- Abide by all cGMP, FDA, and DEA regulatory standards.
Education and Experience:
- Master’s degree in a scientific field.
- 15 years in Quality Assurance, Quality Control, Quality Engineering, with at least 5 years in a senior leadership role.
- Strong experience with Pharma industry regulations
- Minimum 5 years of experience leading teams, including managing managers and multi-site teams.
- Excellent reading, writing, and verbal communication skills.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Strong team player with excellent complaint resolution and negotiation skills.
- Proven administrative management experience.
- Strong leadership, analytical, and problem-solving abilities.
Preferred Skills/Abilities:
- Experience in a global company, regulatory experience for FDA, ANDA submission, DEA.
- Advanced technical degree (PhD, MA, MBA).
If this sounds like you, we want to hear from you!
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.
