VP, Quality & Compliance, Global Joint Reconstruction - Cork

ty
Job Sub Function:
Multi-Family Quality
Job Category:
People Leader
All Job Posting Locations:
Ringaskiddy, Cork, Ireland
Job Description:

Johnson & Johnson MedTech is recruiting for a VP, Quality & Compliance for the joint reconstruction business. The role can be located in Cork, Ireland (Ringaskiddy).

Position Summary

This leader will have accountability for the MedTech Orthopedics $4B+ Joint Reconstruction End-to-End Quality & Compliance organization. Leading 1-4 Senior Director/Director/Sr. Manager/Managers. Total Staff: ~ 550 (Joint Reconstruction Quality Organization). Reporting to the VP Q&C, MedTech Orthopedics.

Responsibilities:

• Defines and assures the effective implementation of the Joint Reconstruction Platform Quality Management System in accordance with Business, Market and Customer needs as well as in compliance with Global Regulatory Requirements. To establish a Quality Management System is a competitive advantage for Joint Reconstruction.

• Acts as a strategic thought partner with business leaders in the development of the 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 J&J 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 all Joint Reconstruction organizations WW. This includes Research & Development, Clinical, Regulatory, Marketing, Sales, Manufacturing, Procurement, Information Management, Communications and New Business Development.

• Influences the 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 in order to meet the goals of the Platform.

• Establish the Platform 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 Platform.

• Participates in MedTech Quality Leadership team and special interest groups to influence regulatory agencies to align with business and customer needs.

• Establishes strategy for quality and compliance auditing and assessments across the Platform 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.

• Responsible for Quality Operations in Warsaw, IN, Raynham, MA, Bridgewater, MA, Palm Beach Gardens, FL, Cork, IE, Leeds, UK, Blackpool, UK, Oberdorf, CH, Suzhou, CN and Costa Rica.

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

• Prioritizes and resources business unit 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.

• To recruit and further develop high caliber Quality & Compliance professionals.

• Escalates significant quality and regulatory issues as applicable in line with Escalation process.

• This individual is also the designated Management with Executive Responsibility for the Joint Reconstruction Platform.

Qualifications:

• Bachelor's degree level qualification, or equivalent experience, master's degree desired
• Minimum 15 years of experience in a medical device, pharmaceutical or similar regulated industry, 10 years of which are at management level, including experience at Management Board level.
• 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 DePuy Quality Policy.
• Ability to effectively negotiate and influence senior company management, other departments, and regulatory agencies.
• Experience with financial acumen (P&L, NOV, ROI, etc., including as related to acquisitions and divestitures) is extremely helpful.
• Digital awareness to help plan strategically for the future.