QMS - GDP Regulations

Highly Competitive
  1. Permanent
  2. Good Distribution Practice (GDP)
  3. United States
Thousand Oaks, California
Posting date: 14 May 2019

An exciting opportunity has arisen with a leading biopharmaceutical organization who are currently recruiting a QMS-GDP (Quality Management System - Good Distribution Practice) Regulations position with their California office. The company has an extensive history in discovering, developing, and manufacturing innovative human therapeutics and focuses on areas of high unmet medical need, leveraging its expertise to strive for solutions that improve health outcomes. This vacancy will be home-based for three weeks per month, with the remaining week being in the organization's office in Thousand Oaks.

The company is looking for a proposed program that aligns with best practices to ensure consistent application of risk management principles within the QMS and Product Quality, Patient Safety, and Product Availability following the regulations and standards for Biologics and Medical Device Products.

Job Responsibilities:

  • Being responsible for the Quality Risk management, Risk assessment, Risk analysis and Risk approach.
  • Implementing Product Control Strategy (QbD and Risk Based Controls).
  • Overseeing Medical Device Risk Management following ISO-14971.
  • Overseeing all QMS activities:
    • Change Control
    • Validation
    • Deviation
    • Internal Audits
    • Quality Oversight of Outsourced Activities
    • Complaints
    • Adverse Events
    • Transportation validation
    • Qualification of Service Providers
    • Contamination Control
    • Environmental Monitoring

Skills and Requirements:

  • Degree in related discipline or sufficient relevant experience.
  • Demonstrable project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at +44 207 440 0679 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.