Commercial Quality and Controlled Substance Manager

Johnson & Johnson Innovative Medicine • Shepherdsville, KY

6d • $102,000 - $177,100 • Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Commercial Quality and Controlled Substance Manager to be located at Somerset, NJ or Shepherdsville, KY.
The Commercial Quality and Controlled Substance Manager is responsible for the oversight and execution of quality and compliance management at the Franklin Distribution Center (FDC) and Kentucky Distribution Center (KDC), including, but not limited to ensuring that all applicable local, state, and federal laws and regulations (Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), Transportation Security Administration (TSA)) are followed. In addition, the Manager, Pharm Commercial Quality and Controlled Substances is responsible for developing and supporting programs and providing DEA regulatory guidance for the JOM Distribution Centers (DCs) to ensure the DCs are in compliance with DEA regulations for controlled substances.

Requirements

• A Bachelor's degree or equivalent combination of experience and education is required.
• A minimum of 8 years of experience in a highly regulated industry is required with strong knowledge of FDA 21 CFR Part 820, DEA Regulations, ISO 9001 and/or ISO 13485.
• Experience with Temperature Control is required.
• Experience working with a crossfuctional organization is required.

Nice To Haves

• QA/QC experience in the Pharmaceutical, Medical Device, and/or Consumer products industry and experience with regulatory inspections is preferred.
• Experience working with Microsoft Office and ERP systems (i.e. SAP, WMS, Master Data Systems, etc.) preferred.
• Experience working with EDI data (852, 867), IMS data and Sales data is preferred.
• Experience interpreting compliance requirements and regulations is preferred.
• Knowledge of DEA and state regulations pertaining to shipping controlled substances including Suspicious Order Monitoring is preferred.

Responsibilities

• Serve as the single point of contact to internal and external partners on distribution quality and compliance related matters and liaise and partner with other functional/business area, such as Facilities, to drive and implement timely and compliant resolutions of issues through to closure.
• Oversight of processes and systems related to cGMPs, including, but not limited to product receipt, handling, storage, and order fulfillment, product disposition (stock release and refusals/returns) and destruction, and Quality Event Management (QEM) system records, i.e. Quality Issues/Quality Investigations, Corrective/Preventive Actions (CAPAs), Effectiveness Checks, Change Controls, etc..
• Managing partnerships/relationships with 3PLs, when applicable.
• Ensure that the DCs are inspection ready for internal audits and external health and regulatory body audits. Lead and/or support such audits. Lead and/or support enterprise and/or global standards gap remediations and audit observation responses.
• Act as a liaison to industry committees and outside agencies.
• Responsible for making quality and compliance based decisions based on assessment of risks balanced with the overall business needs.
• Develop, maintain and implement compliance programs and systems to ensure DEA regulatory compliance at the DCs.
• Identify opportunities for continuous/proactive improvement of quality and compliance, evaluating cost and time factors that are consistent with the business objectives.
• Leadership and oversight of Repack/Relabel, Re-Work, and/or other special inspection activities within the DC.
• Responsible for quality and compliance management of the temperature-controlled facilities, such as oversight for the identification and communication of temperature excursions within the DC and subsequent remediation activities.
• Responsible for Quality and Compliance management input of the Warehouse Management System (WMS) and providing leadership/support to the local Business Technology and IT functional areas on site specific WMS related items.
• Support the 24/7 operations of the DC.
• Responsible for oversight of any Facilities related issues.
• Participate, as required, in Quality System Management Reviews (QSMR) providing visibility/awareness to quality and compliance and controlled substance compliance items.
• Provide security guidance to sites, as needed, including, but not limited to the review and development of controlled substance security procedures, scheduling and communicating with DEA on security changes impacting the facility such as equipment, appropriate security requirements for any movement of controlled substances at either site (import, export, inter-company and customer shipments), and compliance to J&J Global Security policies and Supply Chain Security initiatives.
• Support new product introduction (NPI) by assisting with, but not inclusive of product evaluations, submitting appropriate Controlled Substance registration documents, ensure IT systems (WMS, SAP, and Master Data Systems) are modified to include new products and reviewing site capital projects from a site security standpoint.
• Ensure timely communication/reporting/escalation to the districts on any material losses (Form 106) or diversions. Lead any potential diversion investigations in partnership with J&J Global Security. Escalate all appropriate issues to leadership and ensure timely communication/reporting/escalation as per the J&J procedure requirements.
• Responsible for establishing and/or oversight of internal/external quality agreements.
• Develop and monitor reporting DEA requirements such as ARCOS and DEA Form 41.
• Oversight of controlled substance domestic order/import/exports. Ensure uninterrupted supply of controlled materials (imports, exports, shipments). This involves contact with the Controlled Substance Compliance Center of Excellence (CoE), resolving unusual issues, obtaining special permission and clarification of requirements. Ensure an adequate system is in place to track import/export permits. Ensure proper DEA documentation is completed for each movement (i.e., Form 357, 161, 161R, CSOS, 222).
• Develop, maintain and implement a suspicious order monitoring program to ensure regulatory compliance to Title 21 Code of Federal Regulations PART 1301 §1301.74 (b) through collaboration with Customer Service, Sales, Marketing, Finance and Legal.
• Support and provide expertise/guidance on business projects.
• Provide DEA regulatory expertise/guidance to other DCs, as needed.
• Manage cross functional relationships with key stakeholders including but not limited to Customer Service, Channel Operations, Controlled Substance Compliance COE, Trade, Franchise Integration, J&J Global Security, J&J Brand Protection
• Maintain contact and meet with federal, state and local regulatory personnel relative to controlled and non-controlled substance security and handling issues (i.e. Washington DEA, Newark DEA, Louisville DEA, etc.).
• Keep current on industry trends, proposed changes or new state and federal regulations that effect controlled substance handling/distribution at the DCs.
• Manage a team of direct reports in the areas of people development, skill development, and career development.
• External interactions may include, but is not limited to customers, government/health and/or regulatory bodies, industry partners, 3PLs, and Suppliers.
• Internal interactions may include, but is not limited to Business Technology, IT, Distribution Operations, DELIVER, Facilities Management, Security, and MAKE.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level