Commercial Quality and Controlled Substance Manager

6062-Janssen Pharmaceuticals Legal Entity • Somerset, NJ

5d • Hybrid

About The Position

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). This includes ensuring adherence to all applicable local, state, and federal laws and regulations from agencies such as the Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), and Transportation Security Administration (TSA). The role also involves developing and supporting programs and providing DEA regulatory guidance for JOM Distribution Centers (DCs) to ensure 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.
• 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 cross-functional organization is required.

Nice To Haves

• QA/QC experience in the Pharmaceutical, Medical Device, and/or Consumer products industry.
• 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.
• Liaise and partner with other functional/business areas, 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 product receipt, handling, storage, order fulfillment, product disposition (stock release and refusals/returns), and destruction.
• Manage Quality Event Management (QEM) system records, including Quality Issues/Quality Investigations, Corrective/Preventive Actions (CAPAs), Effectiveness Checks, Change Controls, etc.
• Manage partnerships/relationships with 3PLs, when applicable.
• Ensure that the DCs are inspection ready for internal audits and external health and regulatory body audits, and lead/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.
• Make quality and compliance-based decisions based on assessment of risks balanced with 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 consistent with business objectives.
• Provide leadership and oversight of Repack/Relabel, Re-Work, and/or other special inspection activities within the DC.
• Manage quality and compliance for temperature-controlled facilities, including oversight for identification and communication of temperature excursions and subsequent remediation activities.
• Provide Quality and Compliance management input for the Warehouse Management System (WMS) and leadership/support to local Business Technology and IT functional areas on site-specific WMS related items.
• Support the 24/7 operations of the DC.
• Oversee any Facilities related issues.
• Participate, as required, in Quality System Management Reviews (QSMR) providing visibility/awareness to quality, compliance, and controlled substance compliance items.
• Provide security guidance to sites, including review and development of controlled substance security procedures, scheduling and communicating with DEA on security changes, and compliance to J&J Global Security policies and Supply Chain Security initiatives.
• Support new product introduction (NPI) by assisting with product evaluations, submitting Controlled Substance registration documents, ensuring IT systems are modified for 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 J&J procedure requirements.
• Establish and/or oversee internal/external quality agreements.
• Develop and monitor reporting DEA requirements such as ARCOS and DEA Form 41.
• Oversee controlled substance domestic order/import/exports to ensure uninterrupted supply.
• 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.
• 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.
• Maintain contact and meet with federal, state, and local regulatory personnel relative to controlled and non-controlled substance security and handling issues.
• Keep current on industry trends, proposed changes, or new state and federal regulations that affect controlled substance handling/distribution at the DCs.
• Manage a team of direct reports in the areas of people development, skill development, and career development.

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 period
• 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: Manager