Carolina, PR, 00982, USA
1 day ago
Pharmaceutical Compliacence Officer
We are seeking a **Pharmaceutical Compliance Officer** to ensure regulatory compliance within our drug wholesale operations. This role is responsible for overseeing adherence to federal and state regulations, including FDA, DEA, DSCSA, and state Board of Pharmacy requirements. The ideal candidate will implement policies, conduct audits, and monitor supply chain integrity to maintain compliance and prevent regulatory violations. **Key Responsibilities** 1. **Regulatory Compliance:** - Ensure compliance with FDA, DEA, DSCSA (Drug Supply Chain Security Act), 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 inspections by regulatory agencies (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 regulatory compliance, ethical distribution practices, and anti-diversion measures. - Stay up to date with 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 by regulatory authorities. - Maintain thorough documentation of compliance activities, audits, and regulatory communications. **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, risk assessment, and excellent communication abilities. **Pay Details:** $31.25 to $36.06 per hour Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy 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
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