Head of MedTech Quality & Compliance, VWave

establish a Quality Management System that is a competitive advantage for VWave. The role has Executive Responsibility with ultimate responsibility for Quality and Compliance across VWave organization.

The position is authorized to receive Regulatory Authority Notice of Inspections, and to oversee activities related to regulatory inspections including all necessary follow-up. The position is also designated as the management with executive responsibility for the Quality System for VWave.

Major Duties & Responsibilities

80%: Under general direction and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:

• Acts as a strategic thought partner with business leaders in the development of the franchise business strategy and effectively links the Quality objectives to the business strategy.

• To proactively evaluate, manage, and effectively communicate risk.

• To create and lead a vision for breakthrough innovation with prudent risk management. To seek and leverage knowledge across Johnson & Johnson of industry best practices, emerging technologies, and regulatory developments

• Assures the implementation of policies and strategies for systems to assure compliance with regulations and industry standards. Implements a globally integrated quality management system approach balancing customer satisfaction and regulatory compliance with business objectives.

• To provide comprehensive Quality Management Strategy for VWave WW. This includes Research & Development, Clinical, Regulatory, Marketing, Sales, Manufacturing, Procurement, Information Management, Communications and New Business Development.

• Influences the franchise business strategy by ensuring an appropriate balance of business, customer and regulatory requirements and emerging trends.

• Develop and sets strategic direction for quality and compliance that integrates customer, product and market requirements to meet the goals of the franchise.

• Establish the Franchise Quality Policy and ensures the proactive identification of compliance risks and the corresponding improvement plans. Sets the direction for relevant and emerging regulations through the application of good judgment that balances business needs and compliance risk of the franchise. Participates in MedTech Quality Leadership team and special interest groups to influence regulatory agencies to align with business and customer needs.

• Partners with Compliance to establish strategy for quality and compliance auditing and assessments across the franchise and ensures adequate resources to support the global program. Effectively partners with senior management to support audit readiness/preparation for risk mitigation and corrective and preventative actions and on-going process improvements.

• Partners with Supply Chain and Commercial to set strategies that drive continuous improvements for the customer. Champions continuous improvement initiatives across the franchise that incorporates risk management, process excellence and measurement systems to align business benefits with action and resource prioritization.

• Prioritizes and resources franchise benchmarking activities and participates in best practice sharing internally across Johnson & Johnson and externally to drive competitive advantage.

• Establishes the strategy for the implementation of policies for external source selection, monitoring and control.

• Ability to understand current and emerging regulations and approaches for clinical research involving human subjects and existing requirements for sponsors of clinical investigations involving medical devices.

• Assures a risk management approach which achieves an acceptable risk-benefit balance to quality, compliance and business objectives. Through risk management strategies, supports the franchise in delivering business results and fosters a culture change within the franchise that embraces risk management tools and techniques.

• Chairing the Quality Review Board committee to support product field action decisions.

• Responsible for communicating business-related issues or opportunities to the next management level.

• Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.

20%: General Team Management

• To recruit and/or further develop high potential Quality and Compliance professionals.

• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

• Creates an environment that thrives on diverse perspectives, backgrounds, and talent to generate innovative ideas or solutions, solving organizational challenges

• Leads and holds others accountable to talent acquisition, performance, and development objectives

• Creates a high performing team environment and cohesive culture

• Responsible for Talent development and capability building

• Credo based actions and employee engagement

• Mentoring coaching and stakeholder management activities.

travel required: 30%

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Qualifications

Required Minimum Education: Graduate degree in in science, business, engineering or organizational management or equivalent experience preferred.

Required Years of Related Experience: Minimum 12-15 years of experience managing many aspects of Quality & Compliance in an international, global context, in a regulated healthcare environment.

Required Years of People Management Experience: 10 years

Required Knowledge, Skills and Abilities:

• Demonstrated experience in achieving and maintaining compliant Quality Systems in a large, global Corporation.

• Excellent written and verbal communication skills

• Expert knowledge of FDA QSR, ISO and related standards and regulations and demonstrated expertise in the interpretation and practical application of these requirements.

• Experience of leadership roles in worldwide project management, problem solving and technical projects in multi-cultural sites.

• Demonstrated ability to balance and manage business and compliance risk consistent with J&J Credo and Quality Policy.

• Ability to effectively negotiate and influence senior company management, other departments and regulatory agencies.

Preferred Knowledge, Skills and Abilities:

• Business Acumen: High-level knowledge of company strategy, key business functions and processes, phases of the product life cycle, research & development, design/development requirements, financial information, analytical tools, global launch plans, current business issues, emerging trends, global regulatory environments, and the competitive environment.

• Process Expertise - Has a substantial body of knowledge of processes relevant to quality and compliance of manufacture and production of products in a regulated environment.

• Knowledge of Health Authority Regulations, their application, and implications for a given operating company. Demonstrated knowledge / expertise in Quality System Regulations, ISO 13485, EU MDR, and as applicable international GxP and product/process regulations and expectations. Experience with PMA and 510k submissions, combination product requirements, complaint vigilance.

• Understanding and application of Lean, six-sigma, and other continuous improvement methodologies.

• Product / Operating Group Knowledge - Specific Knowledge/ Skills and Abilities necessary to work in J&J Operating group.

• Leadership & negotiation.

• Excellent interpersonal & communication skills.

Key Working Relationships:

Internal:

• VWave Operating Management Board

• Johnson and Johnson Quality Professional Community

• Corporate Q&C WW and WW Supply Chain

• R&D, Clinical, and Regulatory Leadership

• Commercial Functions

External:

• External Regulatory and Health Authorities
• External Standards setting committees
• External Sub-Contractor Management as required
• Professional Industry Associations in Shaping the External Environment