Valeant Pharmaceuticals

Quality Assurance Manager

US-SC-Greenville
Job ID
9370
Pos. Category
R&D
Pos. Type
Full Time

Overview

Develop and maintain quality systems that comply with Valeant’s quality management system (QMS) and relevant regulatory requirements for the distribution of drugs, medical devices, nutritionals, and cosmetics. 

Responsibilities

  • Ensures that the quality management system requirements are effectively established and effectively maintained in accordance with the requirements of 21 CFR 820, 21 CFR 210/211, 21 CFR 111, Valeant QMS and other applicable laws and regulations for the distribution center (DC).
  • Responsible for reporting on the performance of the DC quality system to management with executive responsibility for review.
  • Develop quality goals and objectives from the Quality Policy that are linked to the business plan. Communicate and implements the Quality Policy.
  • Manage Quality professionals within the distribution centers.
  • Oversee the management oversight, NC/CAPA, validation, change control, risk management, internal/supplier audits, calibration, document control/records management, and training systems.
  • Manage/control quality of product from receiving to distributing ensuring appropriate product conditions and traceability.
  • Communicate the importance of meeting customer requirements as well as regulatory requirements.
  • Sponsor and/or lead quality improvement activities.
  • Manages the Internal and External Audit Programs. Liaison with internal and external contacts with regards to quality issues.
    • Direct Reports: Yes. Will have 2-4 direct reports within multiple US based distribution centers. 
    • Key Relationships: Internal: All DC personnel, other manufacturing sites, corporate quality, regulatory, and logistics personnel. External: CMOs, regulatory bodies, and customers.

 

Qualifications

  • BS in Engineering, Scientific, or Technical field.
  • 21 CFR 111, 210, 211, and 820. Working knowledge of FDA regulations and experience with interacting with external agency.
  • Demonstrated project management and leadership skills, strong written and oral communication and interpersonal skills.
  • Technology Skills: Windows, MS Word, MS Excel. Will require training for CATSWeb.
  • Certified ASQ CQE and/or Lean Six Sigma Green belt preferred.
  • Training in problem solving tools is required (Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis).

Experience:

8-10 years’ experience in pharmaceuticals or medical devices. 

3-5 years’ experience supervising professional level employees.    

Experience in a distribution center environment preferred. 

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