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Controlled Substances Manager, Commercial Quality

Controlled Substances Manager, Commercial Quality

Johnson & Johnson Innovative MedicineDurban, KwaZulu-Natal, South Africa
7 days ago
Job description

Controlled Substances Manager, Commercial Quality

Join Johnson & Johnson Innovative Medicine as a Controlled Substances Manager, Commercial Quality. The role is located in Titusville, NJ, with consideration for Horsham, PA and other NJ / PA sites.

Job Function

Quality

Job Sub Function

Customer / Commercial Quality

Job Category

Professional

Job Description

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‑based advancements. This position supports activities related to the Controlled Substance business within J&J and oversees the Commercial Quality Quality Management System (QMS) for multiple therapeutic areas.

Essential Job Duties And Responsibilities

  • Maintain and continually evaluate the QMS in U.S. and ensure suitability for the commercial business.
  • Participate in escalations relevant to the U.S. 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; provide recommendations for changes and updates that 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 Qualifications

  • Bachelor’s or equivalent university degree in Technical or Life Sciences (MA / ​MS / MBA preferred).
  • 3‑5 years of experience in the pharmaceutical or related industry.
  • Knowledge 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.
  • Equal Opportunity Statement

    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.

    Pay Range

    $100,000 – $173,500

    Benefits

    Employees may participate in company‑sponsored employee benefit programs : medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance and group legal insurance. Employees may also participate in the company’s consolidated retirement plan (401(k)) and long‑term incentive program. Time‑off benefits include vacation, sick time, holiday pay, work‑personal and family time, parental leave, condolence leave, caregiver leave, volunteer leave and military spouse time‑off.

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    Commercial Manager • Durban, KwaZulu-Natal, South Africa

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