Director, Customer Logistic Services, Quality & Compliance – Johnson & Johnson – Skillman, NJ, USA
Johnson & Johnson Customer Logistics Services (CLS) is a global Supply Chain organization that supports operating units across all of the Johnson & Johnson Family of Companies. The Johnson & Johnson Customer Logistics Services team is recruiting for a Director, CLS Quality & Compliance (QC) Medical Device (MD) Distribution US. This position will be located in Skillman, NJ.
The Director, CLS Q&C MD Distribution US is accountable for the oversight and execution of Quality Management Systems and compliance of operations at all MD Distribution Centers within the United States that receive, pick, pack, store, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors globally. The Director CLS Q&C MD Distribution US serves as a single point of contact on Distribution Quality related matters and liaise with J&J Regulatory Compliance (JJRC) and multiple MD Make Quality and MD Business Quality organizations (8 – Acclarent, Anspach, ASP, BWI, DePuy/Synthes, Ethicon, Inc., Ethicon Endo-Surgery, & Mentor) to drive timely resolution of Quality related issues. The Director CLS Q&C MD Distribution US defines and implements departmental strategies and services as the business expert on quality systems, distribution, and quality management. In collaboration with Enterprise CLS Quality and other sectors, execute common distribution standards and Quality Management Systems (where appropriate) and implements within MD. The Director CLS Q&C MD Distribution US optimizes quality systems and processes and ensures alignment with the worldwide business, the quality vision, and provides a measurable impact to quality, cost, and customer value; Identifies opportunities to continuously improve quality, cost and time factors, consistent with Medical Device goals, Consumer-Pharma and CLS business objectives. Identifies significant business issues, prioritize for action, and lead improvement opportunities and problem solutions, escalate any issues to CLS and Franchises Management; understands current and emerging regulations and the impact to quality and distribution practices.
The Director CLS Q&C MD Distribution US, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates. Other responsibilities will be to oversee the controls and quality standards execution for distribution; ensure robust processes are transferred to distribution centers; be the lead Q&C role in multiple projects which involve the divestiture and/or integration of processes within the North America DC network; be the lead Q&C role for integration of Make MD DC’s (ie. DePuy/Loaner Kit Centers) into the CLS organization; evaluate the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations; accountable for robust product disposition procedures and the quality oversight of all product quality holds and field actions impacting the Distribution Centers; oversee and approve deviation and CAPA investigations; define requirements for rework or special inspection to be conducted within the Distribution Center and assess requests and partners with business partners to meet requirements; accountable for adherence to temperature control and monitoring requirements within facility and during transportation (cold chain). The Director CLS Q&C MD Distribution US will oversee Compliance execution of the followings -(but are not limited to) Quality Management Review, Facility validation (temperature mapping), Facility Change Control Process, Inbound receipt, Pick and Pack/Outbound, Repack-Relabel, Stop Shipment/Quarantine, Escalations and New product Introduction; ensure appropriate handling of distribution related service disputes including track and trend and mitigation of Quality related issues. The Director will also be accountable for the successful management of all Health Authority inspections (e.g., FDA) conducted at the MD Distribution Centers in the U.S; responsible for the proactive identification and mitigation of compliance risk at the DCs through QScan, internal audits, and other compliance programs; accountable and responsible for timely and accurate metrics and reports per J&J policies; reporting responsibilities within North America include (but are not limited to) QScan execution, Metric evaluation and reporting in EDGE, EDGE entry updates, Metrics for Distribution Center Management Reviews in the U.S., Establish appropriate goals and objectives, and business measurements for department.
For third parties, the Director CLS Q&C MD Distribution US Distribution Centers is responsible for assuring a robust quality management program in place to oversee the quality practices and appropriate level of skills for quality personnel at the 3PL’s; ensures appropriate distribution supplier quality management processes in place; ensure appropriate internal-external Quality Agreements are in place. The Director CLS Q&C MD Distribution US carries out managerial responsibilities in accordance with the organization’s policies and applicable laws; including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing complaints; and, resolving problems; responsible for the overall direction, coordination, structure, and evaluation of QA Managers and Engineers; provides interpretation of policies and regulations to unique site requirements and problems; acts as quality lead for CLS-QA for management initiatives; sets quality policies and decisions based upon assessments of compliance risks balanced with the overall business needs. The Director CLS Q&C MD Distribution US drives innovation within functional area while ensuring functional initiatives are delivered in a compliant, cost efficient manner; ensures that new initiatives meet customer and regulatory requirements; provides guidance and direction to others for developing and assessing programs; creates a framework within which the organization assesses new approaches to issue resolution and process improvement; serves as a contact and representative for regulatory and industry groups; manages relationships externally and internally across functional areas and sites; represents J&J in professional organizations.
A minimum of a Bachelor’s degree is required. A minimum of 10 years of related experience in a regulated industry is required. QA/QC medical device experience is required. QA/QC consumer and pharmaceutical experience is preferred. An advanced degree in an applicable field of study is preferred. Knowledge of cGMP regulations is required. Expert knowledge of distribution processes, ERP systems (i.e. SAP), and manufacturing/ warehouse management systems is required. Experience partnering with operating companies, operations, distribution, information technology, and other QA partners is required. Must be able to develop long-term strategies and implement corresponding performance standards is required. Must have proven experience interfacing with regulatory and health authorities is required. Substantial knowledge of current operations management approaches and cost drivers is preferred. Must be able to effectively train and mentor employees at all levels of the organization required. Strong business and financial acumen is required. Demonstrates Credo Value, Innovation, master complexity, customer/market place focus, independent partnering, organizational and people development is required. Must be a strong leader to provide site leadership required.
This position will be located in Skillman, NJ. 60% of both domestic and international travel is required.