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Quality Assurance Manager

2 months ago

Thousand Oaks, United States Randstad Life Sciences US Full time

A global Pharmaceutical company that harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

Making a positive difference in the world is at the heart of what we do. Join us to make a difference


  • Prior knowledge in SAP validation preferred
  • Hands on experience with all phases of Software Development Life Cycle (SDLC)
  • Experience and knowledge with GxP and CSV/CSA requirements



FUNCTIONS

May perform or oversee the following functions:

  • Review and approve Requirement Specifications, Design Specifications, Testing Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices
  • Review and approve operational and administrative SOPs
  • Review and approve Change Controls (QA Contact role for CCMS)
  • Review and approve Data Integrity Assessments
  • Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
  • Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data)
  • Anticipates and prevents potential problems
  • Independently develops solutions that are thorough, practical and consistent with functional objectives

QUALIFICATIONS:

  • Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience.
  • Previous experience leading teams, projects, programs or directing the allocation of resources.

COMPETENCIES/SKILLS

  • Prior knowledge in SAP validation preferred
  • Project management skills
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Initiate and lead cross functional teams.
  • Collaborate and communicate with higher level outside resources.
  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
  • Strong communication (both written and oral), facilitation, and presentation skills.
  • Strong skill in working independently and to effectively interact with various levels.
  • Able to manage performance issues and conflict
  • Ability to evaluate documentation/ operations according to company and regulatory guidelines
  • Ability to interact with regulatory agencies
  • Demonstrate the Company Values/Leadership Practices