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Designated Representative / Compliance Manager
Vital Guard Pharma LLC
Location: Milwaukee, WI
Employment Type: Full-Time
About Vital Guard Pharma
Vital Guard Pharma LLC is a licensed pharmaceutical wholesale distributor based in Wisconsin, specializing in OTC diabetic supplies, prescription medical devices, and healthcare products. We are committed to maintaining the highest standards of regulatory compliance, operational excellence, and customer service while expanding our distribution network across the United States.
Position Summary
Vital Guard Pharma is seeking an experienced Designated Representative (DR) / Compliance Manager to oversee regulatory compliance, licensing, warehouse operations, and quality systems for our pharmaceutical wholesale distribution business.
The successful candidate will serve as the facility's Designated Representative and ensure compliance with all applicable federal, state, and industry regulations, including FDA, DSCSA, and Wisconsin wholesale distributor requirements. This role will work closely with company leadership to support licensing expansion, regulatory inspections, SOP implementation, and daily warehouse operations.
This position is primarily based at Vital Guard Pharma. However, business needs may occasionally require the employee to assist at our sister company, USA Medical Surplus (UMS), including providing compliance guidance and operational support within the warehouse environment.
Key Responsibilities
Regulatory Compliance
Vital Guard Pharma LLC
Location: Milwaukee, WI
Employment Type: Full-Time
About Vital Guard Pharma
Vital Guard Pharma LLC is a licensed pharmaceutical wholesale distributor based in Wisconsin, specializing in OTC diabetic supplies, prescription medical devices, and healthcare products. We are committed to maintaining the highest standards of regulatory compliance, operational excellence, and customer service while expanding our distribution network across the United States.
Position Summary
Vital Guard Pharma is seeking an experienced Designated Representative (DR) / Compliance Manager to oversee regulatory compliance, licensing, warehouse operations, and quality systems for our pharmaceutical wholesale distribution business.
The successful candidate will serve as the facility's Designated Representative and ensure compliance with all applicable federal, state, and industry regulations, including FDA, DSCSA, and Wisconsin wholesale distributor requirements. This role will work closely with company leadership to support licensing expansion, regulatory inspections, SOP implementation, and daily warehouse operations.
This position is primarily based at Vital Guard Pharma. However, business needs may occasionally require the employee to assist at our sister company, USA Medical Surplus (UMS), including providing compliance guidance and operational support within the warehouse environment.
Key Responsibilities
Regulatory Compliance
- Serve as the facility's Designated Representative.
- Maintain compliance with federal, state, and local pharmaceutical regulations.
- Ensure compliance with FDA regulations, DSCSA requirements, and applicable state wholesale distributor laws.
- Maintain wholesale distributor licenses, registrations, and regulatory documentation.
- Prepare for and participate in regulatory inspections and audits.
- Coordinate corrective and preventive actions following inspections.
- Develop, implement, and maintain Standard Operating Procedures (SOPs).
- Ensure compliance with Good Distribution Practices (GDP).
- Investigate quality incidents, complaints, and non-conformances.
- Manage product recalls, withdrawals, and corrective action programs.
- Oversee receiving, storage, inventory control, and shipping activities.
- Verify products are sourced from authorized suppliers.
- Ensure proper storage conditions, environmental monitoring, and inventory rotation.
- Monitor quarantine, damaged, expired, and returned products.
- Assist in maintaining warehouse organization and operational efficiency.
- Maintain regulatory records and documentation.
- Assist with state licensing and expansion initiatives.
- Ensure accurate receiving, shipping, inventory, and compliance records.
- Support internal audits and documentation reviews.
- Train warehouse personnel on compliance procedures and SOPs.
- Promote a culture of regulatory compliance and continuous improvement.
- Work collaboratively with management on operational improvements.
- Provide compliance and operational support to USA Medical Surplus (UMS) as needed.
- Assist with warehouse operations, documentation, and compliance-related projects across both organizations when requested by management.
- Minimum age of 21 years.
- One of the following:
- Bachelor's degree in Pharmacy, Chemistry, Biology, Life Sciences, or a related field; or
- At least 3 years of experience in pharmaceutical distribution, medical device distribution, wholesale drug distribution, pharmacy operations, healthcare logistics, or another FDA-regulated environment.
- Strong knowledge of:
- FDA regulations
- DSCSA
- Wholesale pharmaceutical distribution
- Regulatory compliance
- Inventory control
- Quality systems
- Excellent organizational and documentation skills.
- Strong communication and leadership abilities.
- Ability to work in a warehouse environment when necessary.
- Forklift certification is a plus (or willingness to obtain certification).
- Previous experience serving as a Designated Representative.
- Experience with state licensing and regulatory inspections.
- Experience in pharmaceutical wholesale distribution.
- Experience developing and implementing SOPs.
- Familiarity with NABP accreditation standards and Good Distribution Practices (GDP).
- Experience managing compliance in an FDA-regulated warehouse.