Job Summary

The Director, DEA & Licensing Compliance plays a pivotal role in upholding the highest standards of regulatory compliance within our manufacturing Facilities, directly reporting to the Senior Director, Global Quality. This critical position encompasses comprehensive oversight of DEA regulations and management of all Regulatory Licensing compliance, ensuring our operations meet the stringent guidelines set forth by regulatory bodies.

Job Responsibilities

• Maintain awareness of the laws and regulations, keeping apprised of current changes that may affect the organization with respect to DEA governed activities.
• Provide expertise and oversight to internal clients including consultative guidance.
• Serve as principal advisor on DEA issues for the organization’s compliance.
• Leads reviewer and respondent for DEA record requests for Aveva Drug Delivery Systems.
• Oversees and ensures all Regulatory licensing for the facilities and company are current and renewed in a timely manner.
• Spearheads the development, implementation, and auditing of controlled substance handling procedures across all facilities.
• Oversee quota strategy for sites, coordinating quota requests with commercial requirements and key customers and direct site teams to submit quota requests according to the overall strategy.
• Conducts meticulous investigations into controlled substance inventory, addressing any discrepancies exceeding procedural requirements.
• Ensure timely submissions of quota requests to the Agency.
• Thoroughly reviews state board and regulatory agency record requests, submitting them to the Senior Director, Global Quality after initial assessment.
• Review and ensure timely and accurate submissions of all monthly, quarterly, and annual DEA required reports.
• Ensure security practices and storage areas meet DEA requirements.
• Responsible for audit readiness and representing the business to local DEA inspectors, at DEA headquarters and with periodic customer-controlled substance compliance audits.
• Serve as principal with DEA Headquarters on strategic issues.
• Serve as principal with third party DEA Consultants.
• Fosters a creative and collaborative work environment, encouraging teamwork, professional growth, and knowledge sharing among team members.
• Monitors and evaluates employee performance. Provides feedback as necessary.
• Evaluates department headcount needs, conducts interviews and selects qualified candidates.
• Performs other duties as assigned.

Job Requirements

Education

• Bachelors in related field preferably in technical required is essential. An advanced degree is preferable.

Knowledge, Skills and Abilities

• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Proven strong organizational, time management, and project management skills. Demonstrated experience in coordinating project activities
• Strong organizational, interpersonal and communication skills - excellent command of the English language, both written and verbal
• Ability to be a self-starter, work independently and manage multiple priorities in a fast-paced and changing environment
• Ability to challenge the status quo in an effort to drive systemic change and improvements
• Working knowledge of GMP
• Proficiency with Word, Excel, MS Access, SAP (preferred) and statistical software

Experience

• Must have prior experience in DEA/Controlled Substance compliance.
• Minimum of seven to ten years’ experience with chemical processing, manufacturing practices, contract, and inventory control.
• Minimum of five years supervisory experience in a matrixed organization.

Job Type: Full-time

Pay: From $155,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday
• Weekends as needed

Work Location: In person