Director Quality Execution & Projects, Customer Logistics Services (CLS)-00000OLV
Description
Johnson & Johnson is recruiting for a Director, Quality Execution and Projects, Customer Logistics Services (CLS), located in the United States or Canada.
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
The Director, Quality Execution and Projects, Customer Logistics Services (CLS) is accountable for the execution of projects and oversight of Quality Management Systems and Compliance at CLS Distribution Centers and CLS Transportation within the United States that receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors.
The Director, Quality Execution and Projects, Customer Logistics Services serves as the single Quality and Compliance point of contact for North America CLS Q&C to lead distribution, transportation and customer service Projects and Quality Management Systems oversight and reporting who will liaise with CLS Operations North America business partners, business Quality, make Quality and franchise Quality organizations to drive timely reporting of QMS metrics, resolution of Quality related issues and on time delivery and support of Enterprise Projects. This person defines and implements site execution strategies and services as the business expert on quality systems, distribution, and quality management in collaboration with CLS Quality and other sectors and develops common distribution standards and Quality Management Systems and implements within CLS North America DC network and CLS service organizations as appropriate. Responsible and accountable for coordinating and directing quality assurance programs designed to ensure effective and consistent processes that meet established standards by performing the following duties personally or through subordinates:
Optimizes quality systems and processes and ensures alignment with CLS Q&C QS, CLS Operations North America and Business Quality partners consistent with the quality vision and to provide a measurable impact to quality, cost, and customer value. Identifies opportunities through systems data analysis to continuously improve quality execution, cost and compliance consistent with Business Quality, CLS Q&C QS, Enterprise and CLS Operations business objectives. Proactively identifies critical business compliance risk and prioritizes appropriate action to lead timely problem solutions throughout the CLS DC network and CLS services as appropriate. Understands current and emerging regulations and the impact to quality and distribution practices such as FDA, DEA, TSA, DOT, and Standards organizations such as ISO and Notified bodies such as BSI, TUV etc. Establishes and defines measures of controls and quality standards execution for distribution to ensure robust processes are implemented at distribution centers. Executes and maintains quality assurance standards, which adhere to Good Manufacturing Practices, Quality System and ISO regulations. Provides regulatory compliance guidance and accountable for decision making for CLS North America in order to be fully compliant with government and corporate requirements in all states where Distribution Centers operate. Provides leadership to drive Enterprise minded cultural change and process improvements and ensure adequate resources. Hires, retains and develops qualified personnel, as well as resolving all personnel issues and employee performance management. Monitors, reports and leads continuous improvement of CLS North America Quality Systems including: Management Controls, Internal/External Audits, CAPA, QSCAN, Training, Quality Review Board and Management Review, global complaint management, and management of recall/Field correction activities. Establishes procedures and techniques for the control of quality standards and leads the development and improvement of the global Quality systems, policies, procedures and goals at all DC’s in the US. Leads the development of quality functional strategic plans to support organizational goals and provide guidance to functional areas concerning quality system development. Works with cross-functional Enterprise teams to identify and eliminate compliance deficiencies and manage oversight of North America Quality Systems compliance that supports CLS Distribution Centers, Make Distribution Centers and CLS Service organizations as appropriate. Supports and leads as needed DC site FDA, ISO and JJRC inspections including: Escalation communication and coordination with Sector and Franchise quality organization reporting to regulatory agencies including US FDA Investigators, ISO-13485:2003 auditors, and JJRC.
The Director, Quality Execution and Projects, CLS Partners with DC site Quality organizations in Business Quality, Make Quality, CLS Quality and Franchise Quality to correct and eliminate compliance gaps within North America DC facilities through the CLS NA internal audit program and JJRC audits and QSCAN of Make DC facilities to ensure inspection readiness and provide strategic focus for quality and compliance by negotiating and influencing with appropriate DC site Quality organizations and functional areas to identify continuous improvement opportunities. Partners with CLS Operations PMO to implement business solutions and leads compliance efforts associated with Enterprise and Sector projects and activities through effective implementation of Enterprise Standards, gap assessments, action plans and CAPA’s. Executes deployment of external regulatory requirements at DC’s within North America that meet business strategies and effectively negotiate and influence CLS management and Business Quality partners to ensure that regulatory and business needs are met. Understands and effectively manages budgetary requirements and recognize recruiting, developing and managing area personnel 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. Coordinates and reports timely and accurate metrics and analysis 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, Standardization of Distribution Center Management Reviews in the U.S.
Qualifications
A minimum of a Bachelors degree is required and 10 or more years of related experience within a highly regulated GMP environment. MBA or Master's degree is preferred. QA/QC or Operations experience in the pharmaceutical, medical device or consumer products industries and experience with regulatory inspections is required. Quality Systems and compliance experience is required. Knowledge of cGMP regulations is required. Knowledge of distribution processes is required. Knowledge of ERP systems is required. Experience with warehouse management systems is preferred. Experience partnering with operating companies, operations, distribution, information technology, and other QA partners is preferred. Demonstrated ability to develop long-term strategies and implement corresponding performance standards. Must be able to demonstrate strong influencing and negotiation skills to effectively execute responsibilities. Substantial knowledge of current operations management approaches and cost drivers preferred. Prior experience leading or managing cross functional teams is required. Must be able to effectively train and mentor employees at all levels of the organization. Strong business and financial acumen, required.
This role is located at any appropriate J&J site in US or Canada and will require up to 30% travel.
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J2W:LI NA
Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-Canada, North America-United States
Organization: JOM Pharmaceutical Services, Inc. (6162)
Job Function: Quality Assurance
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