Pharmaceutical Distributor Manager - Designated Representative

Biopeptek Pharmaceuticals LLC; Malvern (Chester County); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

100% employer-paid MEDICAL HMO

MEDICAL PPO

DENTAL PPO

VISION

100% employer-paid Basic Life/AD&D + ST Disability

4% 401K Match (Immediately vested Safe Harbor)

FSA

Job summary

Biopeptek Pharmaceuticals LLC in Chester County, Malvern, seeks a qualified Designated Representative (DR/CDR) to maintain compliance in a licensed wholesale drug distribution facility. Responsibilities include oversight of quality systems, regulatory audits, and daily operations. Candidates must possess Florida CDR and/or California licensure or be willing to obtain it immediately. The ideal candidate has at least 2 years of supervisory experience in pharmaceutical distribution and strong knowledge of industry regulations. Comprehensive benefits include 100% employer-paid health insurance and a 401K match.

Qualifications

• Current Florida CDR and/or California Designated Representative licensure or eligibility to obtain.
• Minimum 2+ years of supervisory experience in pharmaceutical distribution.
• Strong knowledge of Board of Pharmacy regulations and GDP practices.

Responsibilities

• Serve as the Designated Representative and ensure compliance.
• Lead all compliance-related activities including audits and inspections.
• Oversee day-to-day distribution operations to ensure efficiency.

Skills

Regulatory compliance and attention to detail

Leadership and operational oversight

Strong organizational and documentation skills

Effective communication and cross-functional coordination

Education

Bachelor's degree in a relevant field

Tools

Microsoft Excel

Job description

Seeking candidate with current Florida CDR and/or California Designated Representative licensure

We are seeking a qualified Designated Representative (DR/CDR) to serve as the responsible person for our licensed wholesale drug distribution facility. This role is accountable for ensuring full compliance with state and federal regulations governing pharmaceutical distribution, including oversight of quality systems, licensure, and daily operations.

The ideal candidate will bring strong experience in pharmaceutical wholesale distribution, regulatory compliance, and operational oversight, and will play a critical role in maintaining an inspection‑ready, compliant, and efficient facility.

Key Responsibilities

• Serve as the Designated Representative (California) and/or Certified Designated Representative (Florida) for the facility, meeting all statutory requirements for licensure and operational oversight
• Maintain full compliance with applicable regulations, including DSCSA, state Board of Pharmacy requirements, and industry standards for drug storage, handling, and distribution
• Lead and manage all compliance‑related activities, including audits, inspections, and ongoing regulatory readiness
• Develop, implement, and maintain SOPs covering distribution, storage, recordkeeping, returns, recalls, and diversion/suspicious order monitoring
• Act as the primary point of contact for regulatory agencies and support state licensing and NABP accreditation activities
• Oversee repackaging operations to ensure compliance with all applicable regulatory and quality standards
• Ensure proper documentation, record retention, and inventory controls are maintained in accordance with regulatory requirements
• Provide leadership and oversight of day‑to‑day distribution operations to ensure compliance and operational efficiency
• Supervise shipping and receiving activities, ensuring accurate documentation, timely processing, and adherence to compliance standards
• Coordinate with carriers and internal teams to support efficient and compliant distribution operations

Requirements

Qualifications

• Current Florida CDR and/or California Designated Representative licensure, or eligibility and willingness to obtain required licensure promptly upon hire
• Minimum of 2+ years of recent supervisory or managerial experience in pharmaceutical distribution, wholesale drug distribution, or pharmacy operations; at least 1 year of experience must be within the last three years (meeting Florida and California DR requirements)
• Strong working knowledge of Board of Pharmacy regulations, GDP practices, and pharmaceutical supply chain compliance (and potentially DSCSA down the line)
• Demonstrated experience supporting regulatory inspections, audits, and licensing processes
• Prior experience in a supervisory or managerial role within a regulated pharmaceutical environment
• Ability to serve as the designated responsible person for the facility and be physically present full‑time as required by law

Preferred Qualifications

• Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, supply chain, or related discipline)
• Experience with NABP accreditation processes
• Familiarity with warehouse and distribution systems, including shipping platforms (e.g., FedEx, UPS)
• Proficiency in Microsoft Excel (e.g., pivot tables, data tracking)

Key Skills

• Regulatory compliance and attention to detail
• Leadership and operational oversight
• Strong organizational and documentation skills
• Effective communication and cross‑functional coordination

Benefits

• 100% employer‑paid MEDICAL HMO
• MEDICAL PPO
• DENTAL PPO
• VISION
• 100% employer‑paid Basic Life/AD&D + ST Disability
• 4% 401K Match (Immediately vested Safe Harbor)
• FSA

PTO: 15 days total (vacation/personal days) + 5 sick days + holidays (the 13 vacation days accrue + earn more days when you hit milestone years)