Senior Manager, Quality Control

US-MA-Watertown
3 weeks ago
Job ID
2017-1080
# of Openings
1
Category
Quality Assurance

Overview

The Senior Manager of Quality Control will assist in the development, implementation and maintenance of global quality control strategies across all phases of drug development through product approval and the post marketing setting.  Assure compliance with relevant regulations and guidelines.  Serve as quality control representative on cross-functional teams.  Communicate with and manage quality consultants, CROs, and other external vendors. 

Responsibilities

  • Manage the quality control function to ensure corporate timelines are met
  • Understand and prepare the quality control function and documentation for commercial production in the future
  • Oversees the development, implementation and maintenance of quality control systems and activities
  • Support of the submission and life-cycle maintenance of US and international regulatory filings
  • Maintain compliance with regulatory requirements
  • Ensure regulatory agency inspection readiness
  • SOP generation and implementation
  • Work closely with Regulatory Affairs to ensure that the necessary documents are available and provided for the regulatory application/submission
  • Oversee and assist in the review and approval of all analytical method development and validation protocols and reports
  • Oversee and assist in the review and approval of Product Development reports and process validation protocols and reports
  • Support development projects by performing due diligence/evaluation audits of potential partners including performing GMP, GCP, and GLP audits

Qualifications

  • Minimum BS degree in a Chemistry
  • A minimum of 5-8 years quality experience working in an API and/or commercial manufacturing, packaging and testing environment
  • Experience with electronic document management and quality systems
  • Experience working with specialty drugs desired
  • Experience working with CMOs and contract laboratories
  • Experience in relevant acute care therapeutic areas (e.g. infectious diseases, critical care)
  • Experience with new product launches on a global scale

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