Lupin Pharmaceuticals (Company Headquarters)

  • DEA Compliance Manager

    Posted Date 3 weeks ago(11/27/2018 9:53 AM)
    ID
    2018-2447
    # of Openings
    1
    Category
    Quality Assurance
  • Overview

    Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions.  Together these entities make up the generic and branded U.S. business.  Lupin has a significant generic pipeline, and a branded focus on women’s health.  Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams.  Lupin is prided on being people-focused and centered around how impactful we are with our customers.  Dollars are not a measure of success but rather the people we help along the way.

    Responsibilities

    The DEA Compliance Manager reports to the Sr. Manager, Site Compliance and functions as the subject matter expert for controlled substances at Lupin Somerset. The Controlled Substance Compliance Manager will be ultimately responsible for controlled substance compliance in the areas of research and development, manufacturing, and distribution. The position requires leadership, good communication, critical thinking and problem solving skills. Filing of required state and federal reporting (ARCOS, Year-end, DEA Form 222s, etc.).

    • Apply for and maintain in good standing all required state and federal controlled substance licensing and registrations.
    • Familiarity with the full DEA quota application process: initial submission, response for additional information, and review and resubmission throughout the year.
    • Supervise the entire controlled-substance product lifecycle: receipt, manufacturing, distribution, and destruction
    • Liaise with state and federal agencies as required.
    • Conduct site-audits for continuous improvement of the CS program.
    • Supervise procedural and in-person training to ensure controlled substance compliance for a range of registrations: manufacturing, research, distribution, etc.

    Qualifications

    • Bachelor's Degree in a Business, Social Science, or Scientific field
    • 5+ years’ experience in controlled substance compliance within the pharmaceutical industry
    • 5+ years supervisory experience including full cycle performance management
    • Must have a working understanding of DEA and FDA regulations (OSHA, EPA, etc.), with extensive experience in the development, maintenance and implementation of DEA Compliance programs
    • Knowledgeable in the technical fundamentals of safety management and risk assessments and reduction, including machinery and process safety, industrial hygiene, loss prevention, ergonomics and occupational health.
    • Possesses a high degree of integrity
    • Possesses the ability to coach, motivate and empower others
    • Ability to think strategically
    • Acts as an agent of change
    • Ability to negotiate and influence across all levels of the organization
    • Excellent verbal and written communication skills
    • Action oriented and results driven
    • Self-directed and able to work independently
    • Possesses sound judgment, excellent analytical and problem-solving skills
    • Flexible and creative in developing solutions that deliver results

    The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office, warehouse, or manufacturing environment.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed