Licensing Specialist

Quva • Sugar Land, TX

1h

About The Position

Our External Licensing Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include managing and overseeing the license vetting process, ensuring compliance with legal requirements, obtaining necessary licenses and permits from customers and vendors as applicable, and maintaining accurate records. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

• Bachelor’s degree in a relevant field, such as business administration, legal studies, or regulatory affairs
• Minimum 2 years’ prior experience in cGMP / FDA regulated industry or Pharmacy
• Excellent technical writing and verbal/written communication skills
• Strong knowledge of licensing regulations, laws, and compliance requirements in the applicable industry
• Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Nice To Haves

• Texas Pharmacy Technician Registration

Responsibilities

• Reviews licensing requirements and develops strategies to meet regulatory obligations
• Verifies all licenses match the required criteria while onboarding new customers
• Verifies data and profile set up in INFOR comply with federal and state requirements for 503B industry
• Ensures all onboarding license documentation is accurate, complete, and submitted within specified timelines
• Tracks expiration dates and initiates renewal process in a timely manner to prevent any disruption in shipping
• Maintains and updates customer licenses via customer portal submission for all existing customers
• Collaborates with internal stakeholders to gather necessary information and documentation to resolve any licensing discrepancies
• Conducts regular internal reviews to ensure ongoing compliance with licensing requirements for all existing customers
• Identifies and addresses any potential compliance gaps or issues proactively
• Prepares reports and documentation as required by regulatory agencies or internal stakeholders during an audit
• Effectively communicates with a diverse group of people, in varying settings to facilitate the licensing process and ensure Quva Pharma operates within regulatory guidelines
• Stays updated on relevant laws, regulations, and industry standards to ensure compliance with 503B, DEA, BOP, DHHS, FDA guidelines
• Provides accurate and timely updates on licensing status, changes, and compliance matters to relevant parties
• Continuously assesses, enhances efficiency, improves licensing processes, and ensures adherence to best practices
• Identifies areas for automation or technology solutions to optimize the licensing process
• Performs the investigation and research that fall within Pharmacy Services for licensing related issues
• Writes and reviews standard operating procedures related to Pharmacy Services
• Establishes & maintains cooperative cross-functional relationships w/peers across all sites in Customer Service & Commercial Operations to meet corporate objectives
• Understands SOPs, cGMP & regulations to accomplish daily tasks
• Participates in team projects and meetings

Benefits

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• A minimum of 17 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees