Quality Assurance Manager, Quality Systems (2 Positions)

Boulder, CO | Quality Assurance

Share This Job

Job Description

Job Summary

The Quality Assurance Manager, Quality Management Systems, will provide primary oversight and maintenance of assigned Clovis Oncology Inc. Quality Systems, Quality Processes, Quality Functions, Quality Standards and Policies, and GxP compliant work instructions.  Support the continuous improvement activities via selection, development/enhancement, and implementation of electronic Quality Management Systems. 

Job Responsibilities

  • Implementation of QA standards, and adherence to ongoing compliance requirements.
  • Lead and/or support project teams developing new or improving existing Quality Management Systems.
  • Assist with the selection and implementation of electronic Quality Management System(s) based on area of focus. 
  • Assist with computer validation activities, as assigned.
  • Determine and communicate ‘Best Practices’ for harmonization of Quality procedures and practices.
  • Compile, analyze, and report on routine Quality Metrics of assigned Quality Systems, including effectiveness assessments.
  • Support in the identification and assessment of quality systems compliance risks and needed risk mitigation strategies.
  • Conduct internal and documentation audits, as assigned.
  • Report to supervisor on project progress, issues, and problem solving.
  • Support Regulatory and Health Authority Inspections as a Subject Matter Expert on Quality Systems and GxP Document Management.
  • Participate on cross-functional teams to support relevant quality requirements.
  • Address other Quality Systems objectives/tasks as assigned

Quality Assurance Manager focused on Learning Management System and Internal Audit Program:

  • Manage the Clovis Training Program / Learning Management System.
  • Working with Management to complete annual training reviews.
  • New hire setup, to include partnering with managers/HR to establish job descriptions.
  • Work with Management on compliance to training.
  • Assist with training system improvement and maintenance.
  • Manage and oversee Internal Audit Program: develop annual schedule, monitor performance to schedule

Quality Assurance Manager focused on Change Control, Issues, and CAPA Management Systems:

  • Manage and track Change Control, Complaints, Deviations, Corrective and Preventive Actions, and associated metrics related to Clovis products.
  • Assist with the selection and implementation of electronic Quality Management System(s) to track Change Control, Complaints, Deviations, Corrective and Preventive Actions.
  • Liaise with Technical Operations and Regulatory Affairs teams as needed in support of assigned systems

Quality Assurance Manager focused on Document Management:

  • Management and implementation of Standards, Policies, Procedures, and Forms to control GxP activities.
  • Assist with the selection and implementation of electronic Quality Management System(s) to track Document Management. 
  • Provide oversight and tracking of Periodic Review process for Standard Operating Procedures and associated Forms.
  • Administer the Document Management system and associated metrics for Product Documentation related to Clovis products.
  • Provide support for SMEs (Subject Matter Experts) for development of department Standards and Policies. 
  • Assist GxP Documentation Archiving Process.

Skills & Requirements

Qualifications

  • Demonstrated ability to define, create and implement procedures and processes which ensure compliance to GxP and regulatory standards.
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
  • Strong technical, analytical, and writing skills to identify and solve problems and document them appropriately.
  • Working knowledge of GMPs (Good Manufacturing Procedures), GDPs (Good Documentation Practices), GCPs (Good Clinical Practices) and Drug Development processes.
  • Demonstrated project management experience and skills, with the ability to coordinate multiple projects in a demanding fast-paced environment.
  • Experience working in a virtual environment preferred.
  • R&D Experience and Clinical Development experience preferred.

Education and Experience

  • At least 10 years’ experience in a quality, documentation, or project management role or combination thereof within a pharmaceutical development setting required.
  • A degree in Biology, Chemistry, Pharmaceutical Sciences, or related scientific discipline is desirable.
  • Area of expertise preferred:  Quality, Project Management, GXP, and Regulatory

Working Conditions

  • This position is office based with limited travel.