• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Director, GMP Quality Assurance

Job Number: 34036

Location:

Job Description

  • Head GMP QA and ensure a culture of continuous improvement
  • Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards
  • Provide QA oversight of device development activities (pre-filled syringes, autoinjectors, etc.) 
  • Develop and maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and batch record review and disposition, to guarantee the consistent production of high-quality products
  • Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures
  • Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization
  • Establish and report key quality metrics to monitor performance and drive improvements in GMP compliance and product quality
  • Lead the GMP vendor qualification program and activities including audits, assessments, and quality agreement negotiation to ensure quality of clinical trial materials and services
  • Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness
  • Ensure personnel are adequately trained in GMP requirements and quality procedures
  • Maintain comprehensive and accurate records and reports related to quality assurance activities
  • Lead GMP inspection readiness activities to support regulatory authority inspections

Responsibilities

  • A Bachelor's or Master's degree in a relevant scientific discipline or equivalent
  • A minimum of 10 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with progressive leadership experience
  • Experience and knowledge of medical device Quality System Regulations preferred
  • Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators
  • In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements
  • Strong leadership, communication, and interpersonal skills with the ability to influence and drive change
  • Excellent problem-solving and critical thinking abilities
  • Ability to manage multiple projects with aggressive timelines and changing priorities
  • Ability and willingness to travel up to 20% (approximately 8-12 times per year for company meetings)

Required Skills

 

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