HireDiversity

Cincinnati, OH, US

Director, Quality Systems and Regulatory Compliance-3821120905

Description

Sedation Systems business, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Quality Systems and Regulatory Compliance, to be located in Cincinnati, Ohio.

Sedation Systems is working on the first computer-assisted personalized sedation (CAPS) system, designed to enable physician/nurse teams to administer minimal-to-moderate propofol sedation to patients undergoing screening and diagnostic endoscopy procedures for colorectal cancer (colonoscopy) and the upper gastrointestinal tract (EGD).

The Director, Quality Systems and Regulatory Compliance is responsible for establishing and maintaining global systems & compliance processes that support customer satisfaction for all customers of the company, including site locations in Canada & US and others as business grows. This individual provides global regulatory compliance interpretation, consulting, training and assessment of the organization and is accountable for ensuring company systems meet current global regulatory requirements, standards and industry trends. Establishes preventative and corrective actions to mitigate potential or actual non-compliance risks. Ensures global systems are implemented and that compliance issues are addressed in a timely manner. Provides leadership to department staff and is accountable for meeting departmental goals and responsibilities. Leads Quality Management Review board and participates on Business Unit Leadership Team to help develop business strategy and ensure that quality strategy supports business strategy while also maintaining compliance/regulatory requirements. Responds rapidly to new learning for a first of a world product to ensure quality and compliance objectives are met. Defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, as well as transfer and steady state phases of manufacturing operations. Serves as Site Management Representative for SEDASYS.

The Director, Quality Systems and Regulatory Compliance clearly defines, communicates and implements the Quality Management System vision throughout the organization. Responsible for establishing and maintaining quality system strategies, processes and structures to deliver customer-focused products and services. Establishes and maintains global quality assurance standards, which adhere to Good Manufacturing Practices, Quality System and ISO regulations. Understands, interprets and influences global regulatory requirements such as: National Regulatory agencies (FDA, MDA, etc), Standards organizations (ISO, IEC, AAMI, ICH, etc.), Notified bodies (BSI, TUV, TNO, etc.). Provides global regulatory compliance guidance and is accountable for decision making for the company in order to be fully compliant with government and corporate requirements in all countries where the company operates. Provides leadership to drive cultural changes and process improvements and ensures adequate resources. Hires, retains and develops qualified personnel, and resolves all personnel issues and employee performance management.

The Director, Quality Systems and Regulatory Compliance is accountable for continuous improvement of the Quality Systems globally, including: Management Controls, Internal/External Audits, CAPA, 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. Leads the development of global quality functional strategic plans to support organizational goals and provide guidance to functional areas concerning quality system development. Works with cross-functional teams to identify and eliminate global compliance deficiencies and manage the global Quality Systems compliance function, personnel and the budget. Leads FDA, ISO and corporate inspections including: global communication and coordination with regulatory agencies including US FDA Investigators, ISO-13485:2003 auditors, and J&J corporate organizations, e.g., Q&C WW and SST. Identifies and partners with process owners to correct and eliminate compliance gaps within global manufacturing facilities through the EES internal audit program and ensure inspection readiness and provide strategic focus for global Quality Systems Compliance by working with appropriate functional areas to identify continuous improvement opportunities.

Partners to implement business solutions and leads global compliance efforts associated with complex projects and activities through effective implementation of the Management Action Plan (MAP) process. Translates global external regulatory requirements into balanced decision-making with business strategies and effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that global regulatory and business needs are met. Understands and effectively manages budgetary requirements and recognize recruiting, developing and managing area personnel. Partners cross-functionally to establish an audit readiness plan for the quality system that aligns with the business strategy. Effectively negotiates and influences senior management and other functional areas to ensure compliance to current and emerging regulations and business needs. Sponsors/champions benchmarking opportunities. Establishes a J&J and external network to ensure knowledge sharing of best practices. Ensures good clinical practices (GCP) integration with regulatory compliance requirements applicable to EES. Understands and supports new approaches to clinical research practices to provide compliance direction. Assesses risk associated with clinical research studies and provides solutions for data integrity and compliance of the quality system. Effectively partners within J&J Quality Management Partners to establish risk management standards that incorporate business and compliance risk. Sponsors risk management initiatives to improve the quality system to deliver business results. Supports a risk management philosophy in the business process. Fosters open communications with regulatory bodies.

Provides leadership in establishing compliance policies within the industry and among regulatory bodies and gains commitment and ownership of compliance risk. Ensures organizational alignment to and execution of key J&J standards such as Environmental Health & Safety, Health Hazard Evaluation, and Post Market Safety and Surveillance Standards. Provides leadership in Business Process Management to ensure effective processes to deliver on the quality and compliance goals. Provides organizational quality leadership through implementation of business models that ensure cross functional collaboration (e.g. Baldrige Model) to deliver results and effectively manage change. Provides leadership with international external suppliers and partners to ensure high quality product design and manufacturing.

This individual will establish productive working relationships within a multi-cultural environment. Effectively engages customers to first determine product requirements, and to then address any potential technology issues they may have during use. Leads and manages Quality Engineering group to ensure new products and existing products meet or exceed quality objectives. Monitors worldwide regulatory and technical standards environments for shift in design-related quality trends. Assesses impact on company and makes recommendations accordingly. Responsible for building capability of organization and leading engineers to create effective Quality Engineering processes at all levels and throughout organization.

Guides high-level engineers (Staff, Principal QE, etc.) in development and deployment of innovative Quality Engineering tools, techniques and systems that will drive product development to successfully achieve key business results. Provides vision and leadership in identification, design and implementation of World-Class Quality engineering systems to support entire product life cycle with focus on business results including prevention and detection of defects at earliest phase of product design, continuous improvement and customer satisfaction. Responsible for Management and organizational development of department staff.

Qualifications


A Bachelor's degree and a minimum of 12 years of leadership experience in Quality Assurance, Regulatory Affairs and/or Quality Systems within the Medical Device industry is required. A Bachelor's degree in Life Science, Engineering, or a related area of study is preferred. A Master's degree in Engineering, Science, Management or Quality Systems Management is preferred. A minimum of 8 years of supervisory experience is required. Process Excellence Black Belt certification is preferred. Certified ISO Auditor certification is preferred. Capital experience is preferred. Experience working on PMA Devices is preferred. Field sales or service experience is preferred.

Experience in leading regulatory body inspections and resultant regulatory compliance improvements/communications, Leading Quality Review Boards and CAPA systems, and effectively leading upper management, regulatory agencies, and suppliers to ensure compliance with regulatory and business needs is required. Extensive knowledge of FDA Quality System Regulation and ISO 13485 Standard is required. Experience in Quality Systems Development is required. Experience with Quality Review Board and recall requirements is required. Experience in CMDR regulations is preferred. Practical knowledge of QSR, ISO, GLP regulations, and Good Clinical Practices is required.

Experience leading in start-up as well as ongoing concern preferred, including the ability to change roles to enable franchise goals and create a sustainable quality system. Experience sitting on leadership board (business unit level) in directing business strategy as well as quality strategy is preferred. The ability to enroll and influence across functional areas is required. The ability to effectively negotiate and influence upper management, regulatory agencies, and industry to ensure compliance with regulatory and business needs is required. Excellent written and oral communication skills are required. A proven track record as change agent in challenging status quo and driving culture change is required. The ability to apply risk management philosophy to business processes, decisions and data is required.

Up to approximately 30% international and domestic travel may be required. This position will be located in Cincinnati, Ohio.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Endo Surgery Inc (6041)