Pharmaceutical Compliacence Officer

Pharmaceutical Compliance Officer – Drug Wholesaler

📍 Carolina, PR | 💰 $65,000 - $75,000 Annually | 🕒 Full-Time

Join Our Compliance Team!

We are seeking a Pharmaceutical Compliance Officer to ensure regulatory compliance within our drug wholesale operations. This role is critical in overseeing adherence to federal and state regulations, including FDA, DEA, DSCSA, and state Board of Pharmacy requirements. The ideal candidate will develop policies, conduct audits, and monitor supply chain integrity to maintain full compliance and prevent regulatory violations.

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Key Responsibilities

1. Regulatory Compliance

✅ Ensure compliance with FDA, DEA, DSCSA, and state Board of Pharmacy regulations.
✅ Manage and maintain licenses, permits, and regulatory filings for wholesale drug distribution.
✅ Oversee compliance with controlled substance distribution regulations, including Suspicious Order Monitoring (SOM) and record-keeping requirements.
✅ Ensure adherence to Good Distribution Practices (GDP) and company policies.

2. Auditing & Inspections

✅ Conduct internal audits and risk assessments to identify potential compliance gaps.
✅ Prepare for and manage regulatory inspections (FDA, DEA, state pharmacy boards).
✅ Develop and implement Corrective and Preventive Actions (CAPA) in response to audit findings.

3. Supply Chain & Drug Security

✅ Ensure DSCSA compliance, including track-and-trace requirements for drug pedigree documentation.
✅ Monitor and assess suppliers and customers for compliance with anti-diversion policies.
✅ Implement security measures to protect against drug theft, fraud, and counterfeit products.

4. Training & Policy Development

✅ Develop and maintain Standard Operating Procedures (SOPs) related to compliance, risk management, and regulatory requirements.
✅ Provide training to employees on compliance, ethical distribution, and anti-diversion measures.
✅ Stay updated on regulatory changes and implement necessary updates to policies and procedures.

5. Risk Management & Reporting

✅ Identify and mitigate compliance risks associated with wholesale drug distribution.
✅ Investigate and report suspicious orders, compliance violations, and adverse events as required.
✅ Maintain thorough documentation of compliance activities, audits, and regulatory communications.

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Qualifications & Skills

✔ Education:

• Bachelor’s degree in Pharmacy, Regulatory Affairs, Business, or a related field (Juris Doctor or advanced degree preferred).

✔ Experience:

• 3+ years in pharmaceutical compliance, regulatory affairs, or quality assurance (experience in drug wholesaling or distribution preferred).

✔ Knowledge:

• Strong understanding of DSCSA, FDA, DEA, and state Board of Pharmacy regulations.

✔ Skills:

• Attention to detail, analytical thinking, problem-solving, and risk assessment.

• Excellent communication skills and ability to work cross-functionally.

✔ Certifications (Preferred):

• Regulatory Affairs Certification (RAC) or Certified Compliance & Ethics Professional (CCEP).

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Job Details & Benefits

📆 Schedule: 8-hour shifts, variable according to needs and challenges.

🎯 Job Type: Full-Time.

🚀 If you are passionate about pharmaceutical compliance and regulatory excellence, apply today!

Pay Details: $31.25 to $36.06 per hour

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance