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Sr Manager, Commercial Quality - 2406208522W

Description

Johnson & Johnson is recruiting for a Sr Manager Commercial Quality, located in Titusville, NJ, Somerset, NJ or Shepherdsville, KY!

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 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. 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:

• 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

Qualifications

Education:

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

Experience and Skills:

Required:

• A minimum of 8 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

Other:

• This position is anticipated to have up to 10% travel

• The anticipated base pay range for this position is 118000 to 203550.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be 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.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location NA-US-New Jersey-Titusville

Other Locations NA-US-Kentucky-Shepherdsville, NA-US-New Jersey-Somerset

Organization Janssen Pharmaceuticals, Inc. (6062)

Travel Yes, 10 % of the Time

Job Function Customer/Commercial Quality

Req ID: 2406208522W