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Manager, Controlled Substance (Site Operations)

Company: Pfizer
Location: Kalamazoo
Posted on: September 23, 2022

Job Description:

Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveManager of Controlled Substance (Site Operations) is responsible for being the source of expertise within the manufacturing site regarding the Federal Drug Enforcement Administration (DEA). Supports the site controlled substance activities including the completion of required records and reports, assessments, provides expert advice and training and generally directs the application of policies and procedures to comply with the DEA laws and regulations. Liaise with DEA when necessary.Continued compliance with DEA and state regulations is critical in ensuring Pfizer can consistently produce and distribute controlled substances and other prescription products. Failure to effectively support the manufacturing and commercial organizations could have significant implications to short term and long-term business strategies.How You Will Achieve ItManager of CS directs and provides leadership for the following functions with the goal of maintaining compliance within the responsible site and enhancing DEA, customer and peer perception of Pfizer:

  • Establishing, managing, and maintaining Pfizer's working relationships with applicable DEA Field Office.
  • Manages quota grants at applicable manufacturing site.
  • Provides expertise and direction within the site regarding the DEA requirements.
  • Supports the development and application of DEA regulatory procedures at the site level.
  • Providing expert counsel for addressing issues that impact compliance with DEA requirements
  • Supports DEA compliance assessment programs.
  • Consulting with Pfizer's legal counsel when legal action is taken against Pfizer for alleged inappropriate actions by Pfizer regarding controlled substance or listed chemical handling.
  • Identifying and acting upon opportunities to promote and strengthen Pfizer's relationship with DEA, and/or our customers.
  • Maintaining written documentation of DEA approvals and agreements
  • Supports corporate-wide DEA programs at the site level, i.e., registrations, procurement quotas, site transfer forms, ARCOS reporting, year-end reporting, biennial inventory, and Powers of Attorney
  • Responding to DEA and other agency requests for information, e.g., customer sales and return data.
  • Conducts investigations into the loss or theft of controlled substances in a timely manner.
  • Leads DEA training development for site personnel and provides the expertise and direction necessary to support the implementation of Corporate DEA training programs at the site level
  • Oversee inventory accountability and reconciliation for all controlled substances at designated sites.
  • Responsible for maintaining all required DEA reports and records related to controlled substances at the site.
  • Responsible for coordinating annual physical inventory of controlled substances including preparing training materials, templates, reconciling against previous inventory and organizing complete and accurate biennial records for inspection.QualificationsMust-Have
    • HS Diploma with ten years of related industryexperience in pharmaceutical manufacturing
    • OR an Associate's degree with eight years of related industryexperience in pharmaceutical manufacturing
    • OR a Bachelor's degree with at least five years of related industryexperience in pharmaceutical manufacturing
    • OR a Master's degree with more than three years of related industry experience
    • OR a Ph.D. with 0-2 years of experience
    • Prior experience handling DEA matters DEA Headquarters and local Field Offices is required
    • Experience with controlled substances and listed chemical requirements is required
    • Must have sound knowledge of product lines, processes and associated technologies to effectively facilitate communication with stakeholders
    • Previous experience in regulatory interpretation of government regulations via compliance and/or regulatory affairs positions is necessary
    • Must possess ability to think strategically, strong attention to detail and ability to problem solve
    • Must operate with highest level of integrity, professionalism and exhibit sound judgement at all levels
    • Proficient in MS Office Applications (i.e., Excel, PowerPoint, Word, Outlook)
    • Strong oral and written communication skills
    • Comprehensive/Working knowledge of Drug Enforcement Agency (DEA) regulations with particular emphasis on Schedule II, all controlled drugs and listed chemical requirements
    • Experience interacting with State and Federal regulatory officials
    • Knowledge and experience in DEA required records (e.g. DEA Forms 222, 263, 357, 161, etc.)
    • Knowledge and experience in receipt, dispensing, manufacturing, packaging, storage, shipping, and destruction of controlled substances (CS) in compliance with State and Federal regulations
    • Knowledge and experience in conducting CS investigations.
    • Ability to analyze and troubleshoot issues, identify CAPAs and proposed actions
    • Knowledge and experience in reviewing CS SOPs to ensure CS requirements are met
    • Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirementsNice-to-Have
      • Experience working in the pharmaceutical industry including API Manufacturing
      • SAP knowledge
      • Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements
      • Regulatory experiencePhysical/Mental RequirementsSitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.Other Job Details
        • Last Date to Apply: September 12, 2022
        • Eligible for Relocation Package: YESRelocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Quality Assurance and Control#LI-PFE

Keywords: Pfizer, Kalamazoo , Manager, Controlled Substance (Site Operations), Executive , Kalamazoo, Michigan

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