Senior 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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Manager, Quality Systems! This position can be located at any US/PR J&J site with a preference for Horsham, PA, Titusville or Raritan, NJ.

Position Summary:

Senior Manager External Quality, P&O is the EQ Global Process Team Leader for assigned Quality System(s):

Manages day-to-day proactive and effective quality processes and systems within the External Quality (EQ) Processes & Operations to support external manufacturing globally. Ensures EQ is in full compliance with regulatory, industry and Johnson & Johnson Supply Chain requirements and standards. Resolves planned and unplanned issues regarding compliance, quality systems and training.

Key Responsibilities:

Leads and manages assigned global processes as assigned. Ensures that quality systems supporting EQ maintain a state of inspection readiness.

• Ensure the effective and efficient day-to-day operation of the Quality System.
• Provide centralized support for regionally implemented processes.
• Design and/or Implement process and supporting system (e.g. digital) improvements as required.
• Streamline assigned Quality Systems in alignment with Cascades and other initiatives.
• Participate in Enterprise and Segment Governance / Council Meetings.
• Interact with other segments and sites to share and implement best practices.
• Monitor and act on Quality System Metrics.
• Maintain the Quality System in a state of inspection readiness.
• Provide training on processes and procedures related to assigned Quality Systems to EQ (and other impacted groups) as required.
• Lead Process and System Improvement Projects for assigned Quality Systems.
• Develop strategies and innovative systems to measure & improve supplier performance, in collaboration with J&J Enterprise segments for assigned Quality Systems

Objectives

• Shape future direction and evolution of quality processes in advance of industry and JNJ changing requirements to support the portfolio incl. new technologies.
• Analyze quality data to prioritize EQ proactive and remediation efforts.
• Serve as External Quality representative on various cross-functional and/or cross-enterprise project teams.
• Identify areas where digitization/technology can be used to support optimization of and deployment of Quality processes.
• Benchmark Quality Processes best practices from other JNJ and/or External parties and incorporate into EQ.

Additional Duties/Sphere of authority

• Compliance with the cGMP requirements and guidelines, which are connected to the respective function.
• Ensures up to date on industry, JNJ and regulatory quality and compliance environment and future trends.
• Liaises with EQ functional teams to ensure awareness of their requirements and to ensure they are up to date on quality process requirements.
• Reviews and approves SOP’s and other documents.
• Performs and/or participates in process improvement initiatives.
• Leads project/cascade teams to implement specific projects as necessary.
• Supports team to maximize their potential. Demonstrate coaching, caring and inclusive behaviors on an on-going basis.

Qualifications:

Education:

• Minimum bachelor’s or equivalent University degree is required.

Required Skills & Capabilities:

• Experience in drugs, biologics, or medical devices qual