Sr. Program Manager Quality Systems

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is currently recruiting a Sr. Program Manager Quality Systems. This position will be located in Santa Clara, CA.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Sr. Program Manager Quality Systems will be responsible for leading multiple Quality System programs and projects that optimize processes and support business objectives while enhancing compliance.  This role will ensure overall execution to meet project objective and timelines.

Key Responsibilities:

• Drive QMS Optimization programs with cross-functional business partners streamlining procedures that support the Quality Management System. Implement process updates to address new regulations and the requirements for market expansion.
• Manage Transformation projects that implement digital solutions to automate and leverage AI and drive process efficiency.
• Collaborates with multiple functions on overall Quality Systems strategy, updates, and processes.
• Coordinates the External Standards program with platform partners.
• Evaluate the strategic adoption of Shared J&J Procedures that enhance and simplify Auris processes.
• Help coordinate Quality Systems Management Review.
• Assist with the coordination of audit readiness activities.  Provide support for FDA, Health Authority and Notified Body inspections conducted at Auris RAD sites, including readiness activities, front- and back-room participation/management and general inspection support as requested.
• Mentor project teams with identification of quality system requirements to ensure compliance.
• Mentors others and promotes a culture of compliance to regulations, standards, and procedures and risk management throughout the organization.
• Proactively engage stakeholders to drive consensus and resolve issues in a timely fashion.
• Support departmental objectives, while adhering to the Johnson and Johnson Credo, as well as safety and environmental policy and procedures.

Qualifications

Education

• A minimum of a Bachelor’s or equivalent degree in Engineering and/or a Scientific discipline is required. Advance degree in Engineering and/or a Scientific subject area is preferred.

Experience:

Required:

• Minimum of 8-10 years of related experience
• Quality Assurance or Quality System Compliance experience in a development or manufacturing environment with a quality system designed to meet the requirements of the FDA Quality System Regulation and ISO 13485
• Minimum 3-5 years of people and program management
• Good understanding of Quality Management System as applied to medical devices and ISO policy and procedures
• Demonstrated experience and knowledge of Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs) and Data Integrity requirements
• Previous work experience engaging in a team-based environment
• Strong communication, organizational, analytical, and problem-solving skills
• Strong interpersonal skills, ability to influence, and work with others in a positive and collaborative manner
• Ability to present data effectively
• Versatility, flexibility, and a willingn