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Director, QS and DS CSS - 2406199355W

Description

Johnson & Johnson Medtech, Cardiovascular and Specialty Solutions Franchise is recruiting for a Director, Quality Systems and Digital Solutions CSS, located in Irvine, CA, Irving, TX, El Paso, TX or Plymouth, MN!

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.jnj.com/.

This role has responsibility for direct interpersonal development and planning, crafting, and implementing tactical business plans to meet Company and Corporate objectives, deployment and execution of policies and standards to ensure systems and products are in full compliance with applicable Corporate, MedTech Center of Excellence, Company, Local, Federal, and international regulations. Also, develop partnership and collaboration with Johnson and Johnson counterparts to ensure alignment and standardization of standard processes. Provide mentorship and support for department staff to ensure departmental goals and responsibilities are met. Ensure that systems are implemented to address compliance issues in a timely manner.

The Cardiovascular and Specialty Solutions Medtech Franchise include the following Product Platforms: Electrophysiology (Biosense Webster, Inc.), Nerovascular ( Cerenovus), Aesthetics (Mentor) and Medical Device Reprocessing (Sterilmed).

Job summary

Leading the implementation of the Quality Systems strategy and execution within the Franchise to include but not limited to Corrective Action/Preventive Action (CAPA), Escalations and Field Actions, Non-conformances (NCR), Quality Systems Management Review (QSMR), Document and Change Control, and Quality Training. The Quality System leader ensures the ongoing effectiveness and continuous improvement of the Quality Management System(s) within the Franchise.

In addition, they are the liaison presenting Quality Systems and Digital Solutions requirements of the Franchise to the Medtech QS/DS Center of Excellence to shape and drive the business objectives.

They will lead the deployment of new QS/DS solutions created at the CoE back into the Franchise

This leader will have responsibility for direct organizational development and planning, creating, and implementing tactical business plans to meet Company and Corporate objectives, deployment and execution of policies and standards to ensure systems and products are in full compliance with applicable Corporate, MedTech Center of Excellence, Company, Local, Federal, and international regulations. Also, develop partnership and collaboration with Johnson and Johnson counterparts to ensure alignment and standardization of best practices. Provide guidance and support for department staff to ensure departmental goals and responsibilities are met. Ensure that systems are implemented to assure compliance issues are addressed in a timely manner and to foster prevention and proactive actions through leading indicators.

The Franchise Director of Quality Systems and Digital Solutions will deploy digital tools striving to simplify and optimize the quality system processes through digitalization.

Key Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Maintains Franchise quality assurance standards, which adhere to Good Manufacturing Practices, Quality System and ISO regulations. Responsible for presenting business related issues or opportunities to next management level.

• Understands, interprets and influences regulatory requirements as they pertain to Franchise requirements such as: National Regulatory agencies (FDA, MDA, etc.), Standards organizations (ISO, IEC, AAMI, ICH, etc.), Notified bodies (BSI, TUV, DEKRA, etc.) o

• Represent or provide representation and inputs to the digital solutions team as part of our goals to automate our quality systems, integrate our data, and advance proactive quality. Participate in project conceptualisation and any other data and digital transformation efforts impacting the Franchise Quality Systems and Digital Solutions organization.

• Participate and where required lead external regulatory agency and notified body assessments and inspections (example: FDA, ISO). Review and participate in issues and/or decisions related to assessments including pre-assessment and post-certification audit activities.

• Hires, retains and develops qualified personnel, as well as resolving all personnel issues and employee performance management.

• Manages execution to the Quality Systems including Management Controls, Training, Document and Change Control, CAPA and Non-Conformance, Escalations and Field actions across the Franchise businesses.

• Participates in the development of Franchise strategic plans to support organizational goals and provide mentorship to functional areas concerning quality system development.

• Supports FDA, ISO, international Health Authority, and corporate communications and inspections including: communication and coordination with regulatory agencies including US FDA members, ISO-13485:2016 representatives, and J&J corporate organizations.

• Represent business as the Quality Systems Franchise leads for Quality Centers of Excellence, Supply Chain and R&D Quality Systems related initiatives.

• Understands and effectively manages budgetary requirements and resources.

• 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

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

• Performs other duties assigned as needed.

Qualifications

Education:

• A minimum of a BS in Engineering, Science, Business or Business Management, or Quality Systems Management is required. Graduate degree preferred but not required.

Experience and Skills:

Required:

• A minimum of 10 years of related work experience with 5 years of leadership experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS .

• Excellent interpersonal skills both written and oral.

• Deep knowledge of FDA Quality System Regulation and ISO 13485 Standards.

• Familiarity with international regulatory Medical Device frameworks and Health Authority requirements.

• Ability to influence across functional areas.

• Subject Matter Experience in Quality Systems Development.

• Solid understanding and experience in managing third party inspections and negotiating with 3rd parties on compliance issues.

• Prior supervisory experience, including leading direct reports is required.

Additional position requirements

• Experience in international Medical Device regulations is preferred.

• Experience or certification in Lean/Six methodologies preferred.

• Professional certifications are preferred.

Responsibility for others & internal interactions

• All employees have a duty to follow applicable laws, regulations, standards, J&J policies and procedures. Examples of required areas of compliance include but are not limited to:

• Quality Systems

• Good Manufacturing Procedures (GMP)

• Good Documentation Practices (GDP)

• Sarbanes-Oxley (SOX)

• Health Care Compliance (HCC)

• Government Contract Compliance (GCC)

• Environmental Regulations

• Records Management

• Johnson & Johnson Business Conduct and Employee Policies

• Extensive knowledge of FDA Quality System Regulation and ISO 13485 Standard is required. Familiarity with international regulatory frameworks and Health Authority requirements is required.

• Demonstrated ability to enroll and influence across functional areas.

• Working knowledge and experience in managing third party inspections and negotiating with 3rd parties on compliance issues.

• Prior supervisory experience, including leading direct reports is required.

Other:

• This position is anticipated to have approximately 20-25% international and domestic travel

• The anticipated base pay range for this position is $142,000 to $215,000. California Bay Area - The anticipated base pay range for this position is $163,000 to $240,000.

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.

• Please use the following language:

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.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-California-Irvine

Other Locations NA-US-Texas-El Paso, NA-US-Texas-Irving, NA-US-Minnesota-Plymouth

Organization Biosense Webster Inc. (6010)

Travel Yes, 25 % of the Time

Job Function Quality Assurance

Req ID: 2406199355W