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Director of Quality – QMS Simplification

Employer
Perkin Elmer
Location
Waltham MA US
Closing date
Feb 2, 2018

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Sector
Pharmaceutical
Hours
Full Time
Organization Type
Corporate
JOB PURPOSE: The Director of Quality will lead initiatives in Quality Management Simplification intended to reduce complexity, and streamline process to obtain the operational efficiency within Diagnostics manufacturing sites. This person is responsible for assessing the established quality management systems of the Diagnostics business manufacturing sites and associated sites against the applicable Quality System regulations to identify and resolve areas of non-compliance, to reduce complexity, simplify processes and procedures to achieve an efficient and effective QMS that supports the business objectives and ensures the safety and effectiveness of the products distributed to our customers. The person will be responsible for establishing a Quality Management System for the Diagnostic Service organization and as needed, participate on project teams to ensure compliance with the QMS of the legal manufacturing site.
DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS:
  • Assess the current QMS of Dx manufacturing sites subject to FDA QSR and/or ISO13485 using direct assessment and retrospective review of both internal and external audit findings to develop a prioritization of required changes and improvements.
  • Work with Ops and R&D to identify and remove obstacles preventing compliance with regulations and internal processes.
  • Develop and implement QMS simplication recommendations to reduce complexity, eliminate non-value added work not required by regulations,
  • Design and establsh a QMS for the Dx Service organization.
  • Serve as needed as Quality lead on projects, as needed.
  • Provide vision and leadership to the quality organizations.
  • Assertive, self-confident leader with ability to drive initiatives to successful completion.
  • Participate in QMR process for manufacturing sites and Dx business level.
  • In conjunction with the Diagnostics Regulatory Affairs, work to facilitate domestic and international regulatory requirements
  • Work with sites to prepare for and participate in inspections and audits.
  • Monitor emerging regulations or market expansion regulations and work with sites to remain / gain compliance with those regulations.
  • Assists sites with audit finding remediation and and responses.
  • As needed, apply continuous improvement principles for system optimization.
  • Capable of building trust, strong relationship and able think clearly under pressure.
  • Able to work in a fast pace environment.

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