HEAD OF QUALITY AND COMPLIANCE, GLOBAL CSS

Johnson and Johnson is currently recruiting for a Vice President – Head of Quality and Compliance, Global CSS At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
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responsibilities OVERALL RESPONSIBILITIES.
To define and assure the effective implementation of the CSS Business Unit 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 that is a competitive advantage for CSS.
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 CSS 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 BU.
Establish the Business Unit 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 BU.
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 BU 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 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 and Compliance professionals.
Escalates significant quality and regulatory issues as applicable in line with Escalation process.
Reports to VP & Chief Quality Officer, Medical Devices.
Direct Reports.
8+Senior Director/Directors.
Total Staff.
~ 850 (CSS Quality Organization).
Qualifications Bachelors degree level qualification MBA, or equivalent experience.
Minimum 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.
The anticipated base pay range for this position is $ to $.
California Bay Area - The anticipated base pay range for this position is $ to $.
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits:- Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.
https://www.
areers.
nj.
om/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.