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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 quality assurance and/or manufacturing is required.
• A minimum of 8 years’ experience in Pharmaceutical, Medical Device, Biotech.
• Ability to develop Quality Systems and provide cGMP compliance support to External Manufacturers is required.

• In depth knowledge of global cGMP requirements is required.
• Seasoned people leader, ability to shape cross functional teams, is required.
• Project management experience is required.
• Strong team collaboration mentoring, and coaching skills are required; experience in leading cross-functional, multi-site and/or international teams.
• Proven track record of successful business or process improvements required.
• Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style required.
• Demonstrated strategic thinking capabilities, ability to define a vision for the future. Ability to translate vision to strategy, and strategy to execution.
• Demonstrated ability to build and nurture strong, positive relationships with business leadership and partners in Global Quality, Procurement, manufacturing, DPDS and across the enterprise. Strong negotiation skills. Ability to build relationships and confidence with suppliers who support J& J.
• Experience in External Manufacturing, Quality Event Management and/or Quality System Development is preferred.
• Advanced knowledge and proven application of Process Excellence tools are preferred.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https: //www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

$120, 000-$207, 000 USD$

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits