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Quality Assurance Manager / Sr Quality Assurance Manager job in Waltham at Yoh

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Quality Assurance Manager / Sr Quality Assurance Manager at Yoh

Quality Assurance Manager / Sr Quality Assurance Manager

Yoh Waltham, MA Full Time
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Search for client LOCAL CANDIDATES ONLY  
Greater Boston, MA, area

Direct Hire - Quality Assurance Manager / Biotech and/or Pharma

REQUIREMENTS:

  • Bachelor’s degree required; ASQ or RAPS certification is a plus
  • 10+ years of quality experience in the biotech and/or pharmaceutical industry
  • Working knowledge of compliance best practices for gene therapy or cell-based products
  • Strong knowledge of US Quality System and International standard requirements
  • Experience dealing directly with FDA and notified bodies, knowledge of appropriate FDA, ISO, and global regulations regarding quality systems is a plus
  • Ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience
  • Strong organizational and computer (Microsoft Word, Excel, PowerPoint, Adobe Acrobat) skills required
  • Detail-oriented with expertise in problem solving and solid decision-making abilities
  • Strong written and verbal communication skills are essential
Responsibilities:
  • Ensures the Quality Management System (QMS) is capable and effective at all levels; achieves and maintains compliance to US and international standards 
  • Interfaces with external personnel (vendors, partners, and regulatory bodies) and internal personnel (management and staff) to drive Quality Assurance tasks and milestones
  • Responsible for audit planning, conduct, findings, responses, and corrective and preventative actions
  • Performs quality system internal audits and drives improvements within the local quality system as needed
  • Monitors the performance of the local quality systems and reports to management
  • Designs and implements a phase-appropriate QMS for a gene therapy/biologic product in an organization with internal manufacturing
  • Management reviews, deviations, non-conforming materials management, CAPA, change control/management, document control, process control, complaints, training, etc.
  • Fosters an open environment of continuous improvement
  • Influences effective compliance-based decisions with cross functional communication and team building skills
  • Assimilates relevant technical, regulatory, and compliance information to formulate suitable strategies and tactics to satisfactorily resolve complex problems
  • Manages daily QA operational activities
  • Manages personnel and provides technical guidance and support

#CB-SPG
#IND-SPG
 

 

Recommended Skills

Document Management Systems
Product Quality Assurance
Pharmaceuticals
Biotechnology
Decision Making
Manufacturing

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