Sr. Program Manager Quality Systems

Johnson & Johnson Innovative Medicine • Santa Clara, CA

3d • $142,000 - $244,950 • Hybrid

About The Position

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.

Requirements

• A minimum of a Bachelor’s or equivalent degree in Engineering and/or a Scientific discipline is 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 willingness to work in an environment with evolving priorities

Nice To Haves

• Advance degree in Engineering and/or a Scientific subject area is preferred.
• Experience in research, design, or process/operation engineering
• Knowledge of FDA requirements for design control and risk management of medical devices
• In depth understanding of international medical device regulations and standards
• Previous experience implementing AI solutions or automating processes is desired

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.

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: Senior