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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, New Jersey (Any City), Pennsylvania (Any City), Somerset, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Controlled Substances Manager, Commercial Quality to join our team located in Titusville, NJ, with considerations given to Horsham, PA and other NJ/PA J&J sites at the discretion of the business.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Essential Job Duties and Responsibilities

The overall purpose of the Commercial Quality, Senior Manager/QA Associate Director for the US LOC is to ensure high quality products and services are available in every market every day. Additionally, this role will support activities related to the Controlled Substance business within J&J. The scope of Commercial Quality responsibility includes the Quality Management System within respective commercial businesses (i.e., Cardiovascular & Metabolism, Neuroscience, Immunology, Oncology, Pulmonary Hypertension, Infectious Disease & Vaccine, and Established Products) as well as quality and/or compliance within these Commercial businesses.

Key responsibilities include:

+ Maintain QMS in U.S. and continually evaluate and have oversight of the quality system for suitability and adequacy for the commercial business.

+ Participate in escalations relevant to the US businesses that are SC led and lead CQ escalations, including root cause investigations, NC and CAPAs to mitigate risk.

+ Continuously supervise the health of the QMS and identify high risk areas, address with CAPA where appropriate.

+ Provide in-depth data analysis of product information including complaint data and review to support management review by providing recommendations for changes and updates to bring business value.

+ Ensure all audit commitments are delivered on time

+ Perform Know Your Customer reviews, 867 data analysis, process permit applications and perform DEA and state regulatory body reporting as needed.

Minimum Qualification

+ Minimum of a Bachelor’s or equivalent University degree required in Technical or Life Science, preferred MA/MS/MBA

+ A minimum of 3-5 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 GxP.

+ Results-driven leader who contributes to stretch goals and delivers results.

+ Ability to build and nurture strong, positive relationships with business partners in IT, Manufacturing, Regulatory Affairs, Commercial and Quality functional groups.

+ Demonstrated understanding of regulatory requirements that impact Commercial Quality specifically, as well as Controlled Substance Regulations.

Other requirements

+ REMS knowledge

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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$100,000- $173,500

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