Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
- Oversee all aspects of regulatory compliance for pharmacy operations, including adherence to FDA regulations, cGMP guidelines, USP standards, and state pharmacy laws.
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Develop, implement, and maintain policies, procedures, and protocols to ensure compliance with regulatory requirements and DEA regulations.
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Serve as the primary point of contact for regulatory agencies, including the FDA, DEA, and State Boards of Pharmacy, and manage inspections, audits, and inquiries.
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Conduct regular audits and assessments of pharmacy operations to identify compliance gaps and implement corrective actions as needed.
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Provide guidance and support to pharmacy staff on regulatory and DEA compliance matters, including training programs and continuing education initiatives.
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Stay abreast of changes to regulatory requirements, DEA regulations, and industry standards relevant to pharmacy operations and implement necessary updates and changes.
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Collaborate with cross-functional teams, including quality assurance, regulatory affairs, legal, and operations, to ensure alignment on compliance initiatives and objectives.
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Develop and maintain a robust controlled substance management program, including oversight of DEA registration, recordkeeping, security measures, and diversion prevention efforts.
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Ensure timely and accurate submission of regulatory filings, reports, and documentation required by regulatory agencies and DEA.
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Serve as a subject matter expert on regulatory and DEA compliance matters, providing guidance and support to internal stakeholders and external partners as needed.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Doctor of Pharmacy (PharmD) degree from an accredited institution.
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Active pharmacist license in good standing with the State Board of Pharmacy.
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Minimum of 5 years of experience in pharmacy operations, with a focus on regulatory compliance and DEA requirements
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In-depth knowledge of FDA regulations, cGMP guidelines, USP standards, and state pharmacy laws pertaining to sterile compounding and 503B outsourcing facilities.
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Strong understanding of DEA regulations related to controlled substances, including registration requirements, recordkeeping, security protocols, and diversion prevention.
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Proven leadership skills with the ability to drive compliance initiatives, motivate teams, and foster a culture of excellence and integrity.
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Excellent communication, interpersonal, and problem-solving skills.
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Detail-oriented with a focus on accuracy, quality, and continuous improvement.
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Ability to thrive in a fast-paced, dynamic environment and effectively manage multiple priorities.
Physical Demands and Work Environment
The Director of Pharmacy will work primarily in a pharmaceutical manufacturing facility, which may involve exposure to chemical substances, cleanroom environments, and production machinery. The position may require occasional evening or weekend work to accommodate production schedules or address urgent issues.