QA Manager - Investigation Review

Role Summary

QA Manager - Investigation Review leads and manages quality investigations within pharmaceutical manufacturing and quality control. The role focuses on ensuring compliance with cGMP, guiding investigations and change control, and maintaining inspection readiness. The position requires strong collaboration across functions to drive quality improvements and CAPAs, with accountability for regulatory communications and supplier quality considerations.

• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work
• Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations
• Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications
• Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management
• Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills
• Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups
• Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs
• Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues
• Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues

• Required:
  
  BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
• Required:
  
  Substantial experience in pharmaceutical manufacturing and quality control
• Required:
  
  Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
• Required:
  
  Knowledge of regulations related to vendor management programs and other industry quality systems
• Required:
  
  Strong critical thinking skills and a proactive approach
• Required:
  
  Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally
• Required:
  
  Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms
• Preferred:
  Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Preferred:
  Knowledge or exposure to data science
• Preferred:
  Strong leadership and team management skills
• Preferred:
  Ability to work under pressure and meet tight deadlines
• Preferred:
  Ability to influence and negotiate with stakeholders
• Preferred:
  Experience in conducting internal audits and supporting regulatory inspections
• Preferred:
  Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity; demonstrated curiosity for responsible AI practices including risk management and ethical use

• Leadership and team management
• Stakeholder engagement and communication
• Problem solving and aptitude for data-driven decision making
• Experience with AI tools and responsible AI practices