Drug Enforcement Administration (DEA) Director

Company Description

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. As we continue to expand our operations, we are seeking a seasoned and strategic leader to join our team as Regional DEA Director reporting directly to the SVP of Manufacturing Operations.

Job Description

The Drug Enforcement Administration (DEA) Director will direct, coordinate, and review the controlled substances (CS) activity, keeping us in compliance with DEA regulations and Veranova policy. The incumbent is also responsible for review and submission of accurate and timely DEA required reports for the US Manufacturing sites.

Key Responsibilities / Accountabilities

• 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.
• Direct site teams to maintain DEA registrations for the West Deptford, NJ and Devens, MA sites.
• Working with Legal, ensure site teams maintain all State Controlled Substance and Board of Pharmacy type registrations current and correct. Complete and file monthly sales reports as appropriate with the State agencies.
• Oversee quota strategy for US sites, coordinating quota requests with commercial requirements and key customers and direct site teams to submit quota requests according to the overall strategy.
• Work directly with Sales team on strategic business projects that include additional controlled substances to current registrations.
• Ensure timely submissions of quota requests to the Agency.
• 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.
• Provide technical leadership for matrixed employees through effective communications, coaching, training, and development; provide leadership for problem resolution to facilitate prompt improvements and enhanced working relations.
• Ensure recruitment of high caliber individuals to meet delivery of business objectives achieved through talent management program and succession planning.
• Direct and provide leadership to drive a Continuous Improvement strategy, ensuring collaboration and sharing of best practice across Veranova and with external partners to maintain effective operations and cost control.
• Take on any other duties which are within the employee's skills and abilities whenever reasonably instructed.
• Indirectly manage 2-3 site-based employees with local DEA functional responsibilities.
• Other duties as assigned.

Qualifications

• Bachelors in related field preferably in technical required is essential. An advanced degree is preferable.
• 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.
• Experience working in an API manufacturing facility is highly preferred.
• Materials management or Regulatory background is ideal.
• Must have excellent interpersonal and communication skills.
• A strong safety awareness and a working knowledge of EHS requirements in a chemical or API manufacturing facility is essential.
• Must be able to demonstrate and lead through Veranova’ s Vision and Company Values: People, Patients, and Innovation.
• Willingness to travel up to 25% of time as required by the needs of the business.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .