Associate Director, Quality Assurance - Engineering

Company: Initial Therapeutics, Inc.
Location: Petersburg
Posted on: May 24, 2025

Job Description:

Position SummaryWe are looking for an Associate Director who has the technical expertise and experience in establishing and maintaining quality systems to ensure the facility, utilities, equipment, and computer systems of the company's compliance requirements are met and run in accordance with GMP regulation and site procedures.Duties & Responsibilities

• Provide leadership, direction, and support to the people within Quality Assurance Engineering and other departments to ensure that they are qualified to achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Establish and maintain the site's quality system processes related to GMP compliance of the facility, equipment, computer systems and manufacturing processes by working across functions.
• Ensure the Quality oversight and review of validation and qualification activities and documentation for the site is performed including assurance that the appropriate resources, materials, and documentation are utilized, and that work is performed in a compliant and controlled manner.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
• Support and ensure compliance of product and process transfers, including validation, from other manufacturing sites.
• Ensure implementation and quality oversight related to the overall compliance of the facility, utilities, equipment, and manufacturing processes.
• Lead operational and inspection readiness for Health Agency inspections.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
• Provide quality oversight for calibration and maintenance programs and ensure they are developed and run-in accordance with GMP regulation.
• Participate or lead in quality risk analysis/assessments, qualification, and approval of suppliers.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Lead and participate in deviation investigations as necessary.
• Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
• Participate in and/or lead health authority (primarily FDA and E.U.) agency inspections at the site.Required Qualifications
  • Bachelor's degree in a scientific discipline with a minimum of 14 years Quality/CGMP management experience including 7 years in a supervisory role in the pharmaceutical industry.
  • Experience in facility, utilities and equipment qualification, computer and process validation and calibration and maintenance programs for the manufacture of sterile injectable medications.
  • Knowledge and experience in translating FDA and European Medicines Agency (EMA) requirements and guidance into operations success including but not limited to Annex 1 requirements for sterile injectable medications, 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
  • Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.
  • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
  • Quality management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
  • Participation and leading activities to support regulatory agency inspections (FDA/EMA) required.
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Keywords: Initial Therapeutics, Inc., Washington DC , Associate Director, Quality Assurance - Engineering, Engineering , Petersburg, DC