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:** Customer/Commercial Quality **Job Category:** Professional **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 NA Sr Manager QS and Perf Monitoring, located in Raritan, NJ, Titusville, NJ, Horsham, PA or Toronto, Canada! 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/. The Regional Sr. Manager Quality Systems and Performance Monitoring is responsible to assess the health and performance of the NA Quality Systems on behalf of the US and Canadian Janssen commercial companies. This includes: + Quality System Management Review (QSMR) Lead for the North American Region including commercial businesses of all therapeutic areas for both US and Canada. Continuously assess the health and performance of the QMS and identify high risk areas, work with business partners in CQ NA to address with CAPA where appropriate. Specific areas of responsibility include: + Analyze and report US and Canada Quality System metrics + Prepare and lead CAPA Review Board meetings + Implement and continuously evaluate the quality systems as per current US and Canadian GxP requirements + Understand North American LOC including US and Canada needs related to quality system and processes **What You Will Do:** + Coordinate the QSMRs for the US and Canadian LOCs, providing in-depth data analysis of product information including complaint data. Prepare annual Quality Review for Puerto Rico. Ensure compliance awareness is highlighted and addressed in the QMR updates to the commercial boards. + Serve as CQ NA lead on the QSMR/Metrics Community of Practice to ensure alignment across all regions and to introduce analytical improvements for data gathering and QSMR preparation. + Support regional Commercial Quality organization and partner with other LOCs to build quality processes and maintain the compliance with J&J standards, ensuring identification and deployment of key processes with other regions. + Evaluates, monitors, and reports on internal compliance metrics, including CAPA, NC, Escalations, audit commitments, change controls, etc., ensuring appropriate management oversight and notification of compliance risk per company standards and/or in support of Management Review, + Strategic key performance indicator development for critical compliance programs across North America (e.g Drug Establishment Licensing, Confirmatory testing, etc. in Canada). + Serves as the Chair of the monthly CAPA Review Board meeting for Scientific Affairs, Medical Affairs, Deliver, Sample Compliance and CQ NA (US and Canada), facilitating non-conformance and CAPA oversight, timely completion of CAPA, identification of overdue CAPA or resource issues. Ensures ongoing documentation and reporting on CAPA Review meeting activities. + Prepare for, participate in and actively support as SME for North American CQ internal, HA audits, (Global CQ audits as the need arises) and ensures commitments are delivered on time. + Prepare Quality Plans annually for both the US and Canada. + Master Data lead for CQ North America and key stakeholder on global digital initiatives related to Quality Systems. **Special requirements:** + Required: BA/BS – Chemistry/Microbiology/Technical/Life Science + Desirable: MA/MS/MBA – Business/Technical/Life Science **Other features of the job:** + Frequently collaborating with other partners such as Scientific Affairs, Global Medical Organization, Supply Chain, Innovative Medicine Sector Quality System, Global Regulatory Affairs, Enterprise Quality. Occasionally interacting with external service provider or vendors. Participate in or Lead CQ process improvement initiatives and projects related to the QSMR and metrics topics. **Knowledge and skills needed:** + Highly collaborative and strong partnership skills to actively participate on teams and represent the commercial business. + Partnership mentality to ensure cross functional team alignment is acquired. + Minimum 10-years’ experience in the Pharmaceutical or related industry; + Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes; + Up-to-date knowledge of relevant pharmaceutical legislation and GMP/GDP in both US and Canada **Core proficiencies required for this role:** + Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers, partners and senior leadership across commercial functions + Proven strong influence across cross-functional groups. + Outstanding communication (verbal, written), interpersonal and project management skills + Canadian and US FDA Regulatory Requirements knowledge + Demonstrates agility and adaptability in learning new technologies and business processes + Able to prioritize and pull information together from multiple business units to ensure concise consolidated business picture is communicated to the commercial businesses. + Able to balance project management aspects in conjunction with daily work. + Outstanding attention to accuracy and details **Job location:** + Role location can be at an Innovative Medicine office in Ontario, Canada or New Jersey, US with up to 10% travel. **Delegation:** + This role may act as a delegate for: Director, Commercial Quality Excellence North America 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 . 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 and 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 email the Employee Health Support Center ( ra-employeehealthsup@its.jnj.com ) or contact AskGS to be directed to your accommodation resource. **The anticipated base pay range for this position is :** $120,000-$207,000 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)). This position is eligible to participate in the Company’s long-term incentive program. 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