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Sr. Manager, GMP/GDP Audit and Inspection Management
Boston, MA  Posted: 12/3/2019

Details:

Title/Role: Sr. Manager, GMP/GDP Audit and Inspection Management     Area: Quality Assurance
 
 
General position summary:
The Sr. Manager, GMP/GDP Audit and Inspection Management in Quality Assurance is responsible for the oversight and management of quality activities related to CMC activities, inclusive of R&D and Commercial (internal and external), including the oversight of Manufacturing/CxO compliance and distributors, developing and executing audit plans and onsite vendor audits. This Sr. Manager level position will be responsible for leading a team responsible for the successful execution of the GMP/GDP Audit and Inspection Preparation and Management Program.   
 
Key Responsibilities:
  • Serves as CMC Lead of the GMP/GDP Audit function with responsibility for the overall planning, execution and effectiveness of the audit program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with GMP/GDP regulatory requirements (and guidances, etc.)
  • Partners with QA leadership (e.g. QA Vendor Management ,Computer Systems QA, Functional Area QA) and business leadership for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement across vendors and internal operations (e.g. audit planning, review of audit outcomes, and corrective/preventive action development and implementation)
    • Develops, maintains, and executes strategic Audit Plans for to support CMC audits (GMP/GDP)
      • Conducts GMP/GDP Vendor qualification and requalification audits
      • Provides oversight and tracking, for audits that are outsourced
      • Executes directed or For-Cause audits, as needed
  • Engages in Preparation, Support and Follow-up activities for Regulatory Inspections.
  • May serve as CMC Quality Management System representative
    • Reviews and analyzes key Performance Indicator data and trends
    • Analyzes risk and proposes remedial, corrective and /or preventive actions
 
Minimum qualifications:
  • M.S. (or equivalent degree) 10+ years of relevant work experience, or
  • B.S. in a scientific or allied health field (or equivalent degree) 13+ years of relevant work experience, or relevant comparable background
  • 5+ years experience in a Quality Management role
 
In-depth knowledge in the following areas:
  • GMP/GDP Audit processes
  • GMP/GDP Quality Systems
  • Global GMP regulations (US/EU etc.); 21 CFR Part 210/211, ICH guidelines and high level knowledge of 21 CFR Part 11 and International equivalents as necessary
  • CMC Documentation (e.g., NDA Submissions.)
  • Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
  • Risk management principles and process, change management
 

Job ID#:

6976

 



 

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