JVT Advisors

QA Audit Manager

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Location: Lexington, Massachusetts
Employment Type: Direct Hire

Job Description

Looking for a highly motivated and experienced individual that will be part of the External QA Operations Group.

You will be responsible for managing and performing vendor audits as well as management of the contractor and clinical phase suppliers GMP approved supplier list and audit schedule. 

Minimum Education & Experience Requirements:

  • BS in scientific discipline or equivalent
  • 10-15 years of experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms
  • Certified Quality Auditor is considered a plus

 

Knowledge/Skills Needed:

  • Expert knowledge on regulatory requirements and industry expectations for Vendor / supplier Quality Management
  • Working knowledge of US and European Drug Product GMP requirements and associated guidelines including working knowledge of ICH Q7 API GMP Guide  
  • Experience with Quality System Regulation (QSR), GCP, and/or GLP is considered a plus
  • Experience in administration and development of quality systems
  • Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
  • Experience in product development and expectations for early phase clinical trials
  • Strong decision maker, applies job related skills and understanding of policies and standards in completing tasks
  • Strong focus on continuous improvement, customer service and collaboration
  • Strong written and oral communication skills
  • Ability to be influential across levels of the organization
  • Demonstrated leadership skills are critical to this role

 

Personal Attributes Needed:

  • Team Player committed to quality
  • Motivated self-starter committed to detail and results
  • Well organized, efficient worker with good communication skills 
  • Innovative thinker and problem solver with flexibility to embrace change and manage multiple duties and tasks
  • Ability to work in a fast-paced environment with multiple issues open simultaneously
  • Customer service mindset, identifies opportunities to improve and contributes to problem solving
  • Ability to travel up to 40% of the time

 

#jvt

 

Yhoumey Won

Recruiter

Yhoumey is a recruiter for our direct hire team. She enjoys partnering with candidates to find the right career placements.

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