VP Quality & Compliance, Vision

Johnson & Johnson Innovative Medicine • Jacksonville, FL

1d • $199,000 - $366,850 • Onsite

About The Position

Acts as a strategic partner with business leaders in the development of the segment business strategy and effectively links the Quality objectives to the business strategy. Including interfacing with Sr. Executive Management, Company Group Chairs, Corporate Staff, and EC members. Provides key strategic direction and oversight for all areas of Quality & Regulatory Compliance in the segment, integrating customer, product and market requirements in order to meet the goals of the business, with direct reports encompassing all quality & compliance talent in the segment. 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 all Franchise organizations globally. This includes Research & Development, Clinical, Regulatory, Marketing, Sales, Manufacturing, Procurement, Information Management, Communications and New Business Development Sr. Executive Management, including Company Group Chairs, Corporate Staff, and EC members. Influences the segment & Franchise business strategy by ensuring an appropriate balance of business, customer and regulatory requirements and emerging trends. Leads processes, organizations, and governance to assure that all quality & compliance related requirements and goals for the Franchise are achieved at all levels - segment, franchise, operating company, and site level Is a member of the Johnson & Johnson MedTech Quality & Compliance Leadership team (MTQCLT), responsible for recommending policy and standards across the enterprise and representing the segment on that leadership team.

Requirements

• Bachelors Degree - Scientific Discipline or equivalent related experience; masters degree preferred.
• Minimum of 15 years of working experience in the quality assurance and/or regulatory compliance environment, with at least 10 years management experience.
• Strong communication, organizational, negotiation and interpersonal skills.
• Knowledge, understanding and application of quality and regulatory compliance principles, concepts and practices related to quality systems regulated by domestic and foreign governments.
• Understanding and knowledge of a broad set of regulations and standards (21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, etc.)

Responsibilities

• Ultimate authority and responsibility for quality and compliance for the Franchise.
• Establish the 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 business.
• Member of the MTQCLT and external special interest groups to influence regulatory agencies to align with business and customer needs.
• Member of the Franchise GOC.
• Establishes strategy for quality and compliance across the business and ensures adequate resources to support global programs.
• 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 Operations and Process Excellence to set strategies that drive continuous improvements for a better customer experience.
• Champions continuous improvement initiatives across the Francise that incorporates risk management, process excellence and measurement systems to align business benefits with action and resource prioritization.
• Prioritizes and resources benchmarking activities and participates in best practice sharing internally across MD Segment and 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 new drugs for human use (including biological products for human use) and 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 segment that embraces risk management tools and techniques.
• To recruit and further develop Diversity, Equity and Inclusion driving high performing Quality and Compliance professionals, inspired leaders and a strategic workforce plan to enhance future capabilities.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Executive