Sr. Supply Chain and Controlled Substance Manager

Employer
Civica Rx
Location
Petersburg, Virginia
Posted
Jan 08, 2022
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
About Civica

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration's shortage list. Manufacturing challenges and predatory pricing are both the cause and result.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Led by an experienced team of health care and pharmaceutical industry leaders.

Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines.

Civica is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been Do What Is in the Best Interest of Patients.

Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.

To find out more about how Civica's innovative model is directly impacting patient care, click here to read a recent article from the New England Journal of Medicine.

Intro to Civica

Watch this video to learn more about Civica!

Position Summary

The Sr. Supply Chain and Controlled Substance Manager is responsible for implementing and managing site Supply Chain functions, including Supply Planning, Warehouse Operations, Inventory Control, Logistics, and Controlled Substance Management for the Civica, Petersburg manufacturing facility.

Essential Duties and Responsibilities
  • The essential functions include, but are not limited to the following:
  • Oversees site integrated supply chain duties associated with, but not limited to, supply planning, production planning, and material requirements planning.
  • Manages warehouse and logistics Operations (including general shipping, receiving, and freight management) to ensure compliance with cGMP requirements, standard operating procedures, guidelines, and policies.
  • Manages DEA programs, i.e., inspections, registrations, procurement quotas, ARCOS reporting, year-end reporting, biennial inventory, and responds to DEA and other agency requests for information and reports.
  • Leads the development and application of DEA regulatory policies and procedures for quota requests, operational controls, storage, and transport of controlled substances within Civica's Operation. Ensures operations are carried out in full compliance of DEA regulations for the processing of controlled substances and other applicable FDA regulations.
  • Collaborates with other facility colleagues to ensure understanding and alignment to 21 CFR Part 1300 - End requirements are adequately documented and adhered to.
  • Coordinates and submits Controlled Substance Quota Applications for Civica's Petersburg manufacturing site.
  • Coordinates the Annual and Biennial inventory efforts at the site as required by 21 CFR Part 1300 - End and/or company policy.
  • Maintains written documentation of DEA approvals and agreements.
  • Serves as the Subject Matter Expert for operational issues regarding the collection and documentation of CS data for production reconciliation activity and inventory systems. Review critical calculations as they relate to controlled substance accountability. Perform investigations of deviations of controlled substance accountability issues.
  • Ensures compliance to all regulatory (DEA, FDA, NC Department of Agriculture and The Controlled Substance Branch of the NC Department of Health and Human Services) procedures and policies for the processing of controlled substance materials and products while maintaining high alert to diversion and theft possibilities.
  • Provides an independent (third party) verification of accountability for the handling of controlled substance at crucial process points.
  • Provides supervisory oversight in the production, distribution and testing of controlled substance products.
  • Completes documentation to verify independent observations at critical process points.
  • Prepares DEA correspondence and informational packages.
  • Develops and maintains written procedures as it pertains to warehouse operations, logistics, production planning, and inventory control.
  • Interacts with various cross-functional teams to provide support and ensure timely completion of tasks in alignment with company mission.
  • Assures compliance with federal, state, and local regulations as well all site safety requirements.
  • Supports the development, implementation, and management of company ERP system, especially as it pertains to controlled substances management, production planning, material planning, warehousing, logistics, and inventory control.
  • Creates a culture of continuous improvement.
  • Hires, recruits, coaches, and trains employees within the Supply Chain group (warehouse, logistics, supply planning, and inventory control).
  • Continuously assesses and ensures the appropriate Supply Chain structure is in place to support growth. Identifies gaps and ensures the proper hiring and development of employees.
  • Completes thorough root cause investigations and corrective actions for any deviations in a timely manner.
  • Develops, implements, and leads training programs related to controlled substance handling, internal control requirements, and employee qualifications.
  • Ensures staff training is documented and in compliance with current cGMP and DEA requirements.




Minimum Qualifications (Knowledge, Skills, and Abilities)
  • Bachelor's degree in related area and 5-7 years in Supply Chain Management, Controlled Substance Management, and Warehouse Management, with increasing responsibility in a cGMP environment. Parenteral pharmaceutical experience preferred.
  • An equivalent combination of education and directly relevant DEA interactions, controlled substance handling and inventory Control experience may be considered for the right candidate.
  • 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.).
  • Advanced computer applications skills (Excel, Word, Visio, ERPs, and PP).
  • Excellent written and oral communication and presentation skills with the ability to speak and communicate effectively with both senior management and front-line staff personnel.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.



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