DEA Compliance Manager

Job Summary
A rapidly growing specialty pharmaceutical company is seeking an experienced and highly motivated DEA Compliance Manager to oversee and maintain all aspects of controlled substance compliance. This role is responsible for ensuring compliance with Drug Enforcement Administration (DEA) regulations, Title 21 CFR Parts 1300-end, and applicable federal, state, and local regulatory requirements. The DEA Compliance Manager will lead regulatory reporting, auditing, inspection readiness, controlled substance accountability programs, and compliance initiatives while serving as the primary liaison with regulatory agencies.
This position also provides leadership for DEA Compliance personnel and plays a key role in safeguarding the integrity of controlled substance operations through effective compliance oversight, risk mitigation, and continuous improvement initiatives. Position level will be commensurate with experience.

Key Responsibilities:

• Manage day-to-day DEA and state controlled substance compliance activities.
• Serve as the primary liaison with the DEA, state Departments of Health, Boards of Pharmacy, and other regulatory agencies, as required.
• Develop, revise, and maintain policies, procedures, and work instructions to ensure proper documentation, traceability, accountability, and diversion prevention.
• Prepare and submit required DEA reports and filings, including ARCOS, CSOS, Year-End Reports, Quota Procurement Requests, and other regulatory submissions.
• Coordinate and oversee controlled substance inventory reconciliations and audits for all DEA registrations, including annual, biennial, and year-end inventories.
• Investigate inventory discrepancies, in-transit losses, and suspicious orders, and coordinate reporting to the DEA and applicable state agencies as required.
• Ensure all controlled substance storage locations and facilities remain compliant with federal and state regulations.
• Partner with Quality, Environmental Health & Safety (EHS), Security, and Operations teams to maintain compliance and support continuous improvement initiatives.
• Coordinate and oversee controlled substance destruction activities, including both internal and third-party destruction processes.
• Maintain compliance with current Good Manufacturing Practices (cGMP), company policies, and regulatory requirements.

• Lead DEA and state regulatory inspections and serve as the primary compliance representative during audits.
• Support FDA inspections, customer audits, and other regulatory assessments as needed.
• Maintain accurate and audit-ready DEA documentation and records.
• Conduct DEA compliance assessments and due diligence reviews for acquisitions, mergers, partnerships, and newly integrated facilities.

• Manage and develop DEA Compliance personnel, including hiring, onboarding, training, coaching, and performance management.
• Coordinate employee training and professional development programs related to DEA compliance and regulatory requirements.
• Conduct performance evaluations and provide ongoing feedback to support employee growth and departmental effectiveness.
• Collaborate with executive leadership and Quality Management to ensure compliance risks and issues are addressed promptly and effectively.
• Support departmental budgeting and resource planning activities.

• Perform other duties and special projects as assigned.

Education and Experience

• Bachelor's degree in a scientific discipline or related field.
• Minimum of 8+ years of pharmaceutical industry experience with progressive responsibility in DEA compliance, controlled substance management, regulatory affairs, quality, or a related function.
• Previous leadership or management experience preferred.
• Extensive knowledge of DEA regulations, controlled substance reporting requirements, and pharmaceutical manufacturing operations strongly preferred.
• Experience interacting directly with regulatory agencies and managing regulatory inspections preferred.

Knowledge, Skills, and Abilities

• Comprehensive knowledge of DEA regulations, Title 21 CFR requirements, and controlled substance compliance programs.
• Strong understanding of current Good Manufacturing Practices (cGMP) and pharmaceutical manufacturing operations.
• Demonstrated ability to identify compliance risks and implement effective corrective and preventive actions.
• Excellent analytical, organizational, and problem-solving skills.
• Strong verbal and written communication skills with the ability to communicate effectively across all organizational levels and with regulatory agencies.
• Proven leadership, coaching, and team development capabilities.
• High attention to detail and commitment to accuracy.
• Proficiency with Microsoft Office Suite and related business systems.
• Ability to manage multiple priorities and perform effectively in a fast-paced, highly regulated environment.

Benefits

• Competitive Compensation
• Performance-Based Incentive Program
• Medical, Dental, and Vision Insurance
• Paid Time Off
• 401(k) Retirement Savings Plan
• Professional Development Opportunities

Estimated Min Rate: $115500.00
Estimated Max Rate: $165000.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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