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SENIOR Manager/Associate Director, QMS Quality

Position Summary

Hands on position with focus on establishing and maintaining QMS procedures and controls to meet regulatory and ISO requirements. Assessing the effectiveness of the QMS through regular analysis of metrics, internal audits, corrective and preventive actions, customer feedback, and other activities as appropriate. Monitoring metrics for the measurement of Quality Indicators to ensure the effectiveness of the QMS.  . Manage the quality and compliance of Contract Manufacturing Organizations (CMOs) that allows the timely disposition of Clinical Supplies.

 

Individual

A hands on and enthusiastic individual with strong attention to detail and organizational skills with respect to Quality Assurance and Quality System in the drug/medical device/combination product industry. Must be able to work effectively in a development environment and function effectively as a hands-on team member. They must be able to work very effectively, communicate well and establish strong relationships with the technical staff in R&D, Engineering and Manufacturing/Operations. They must represent the company to external contract manufacturers, suppliers, regulators and customers.

 

Main Responsibilities

  • Manage the QMS to ensure compliance with applicable national and international standards and regulations.

  • Manage the Document Control System to support day to day operation

  • Review and update the QMS: scope, policy, manual and procedures to assure compliance with ISO and regulatory requirements that drives continuous improvements as required.

  • Participate in Health Authority and Notified Body audits.

  • Plan, schedule and conduct internal and/or external (supplier) quality system audits per audit schedule

  • Compile and conduct Quality Management Reviews (QMRs) that evaluates the performance of the QMS

  • Publish Quality metrics assesses QMS performance.

  • Cooperate with management personnel in formulating and establishing company policies, procedures, objectives and goals regarding Quality Management System

  • Be a leader in driving quality improvement by performing gap analysis on the QMS and recommend solutions or changes in procedures to address gaps

  • Manage the quality and compliance of Contract Manufacturing Organizations (CMOs) that allows the timely disposition of CTM in support company objectives.

  • Collaborate with Chrono and CMO Quality and Technical groups to ensure quality issues are resolved in a timely manner

  • Assist in the preparation and update of Quality Agreements to support QA operational compliance of CMOs

  • Be the QA lead on CMC and project teams

  • Drive inspection readiness strategy and activities and serve as a subject matter expert in quality systems

 

Reporting Relationship

This position reports to the Sr. Director, Quality Assurance.

 

Job Requirements

Education:

  • BA or BS in Biology, Engineering or equivalent.

Experience:

  • 8+ years in Quality Assurance and Quality Systems in the drug or medical device industry.
  • Combination drug/device product experience preferred.
  • Extensive knowledge of ISO 13485, 21 CFR 820, 210 and 211.

Expertise:

  • Document Control
  • Quality Assurance
  • Quality Systems
  • FDA regulations
  • 21 CFR 210/211, 21 CFR 820
  • ISO 13485
  • SOPs
  • change control
  • audits
  • deviations
  • CAPA
  • MS Word, Excel, PowerPoint

Supervision:

  • Management of QA/QS staff

Equipment Used:

  • Personal computers, statistical tools

Travel Requirements:  

  • May require ~5-10% travel to contract manufacturers and suppliers
 

APPLICATION FORM

Interested in the Sr. Manager/Associate Director, QMS Quality role? Please submit the following application form.

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