Senior Director, Quality Assurance

4 days ago

South San Francisco, California, United States Hibio Full time
Job Summary

We are seeking a highly experienced and strategic Senior Director, Quality Assurance to join our team at Hibio. This role will be responsible for overseeing and participating in the development, implementation, and maintenance of quality management practices and systems to ensure compliance with internal policies, business objectives, procedures, and external regulations and standards.

Key Responsibilities:
  • Develop and maintain a phase-appropriate Quality Management System (QMS) and oversee its administration.
  • Ensure quality and operational regulatory compliance; act as a subject matter expert for quality investigations, documentation systems, training programs, and internal/external audits.
  • Represent quality with external suppliers; maintain and implement appropriate supplier qualification processes.
  • Provide oversight for the qualification process used in the selection and qualification process of clinical, nonclinical, and manufacturing vendors/contractors.
  • Participate in the selection, qualification, and oversight of services of local quality consultants and Qualified Person (QPs) in various geographic regions where GXP contracted activities are needed.
  • Oversee clinical/pre-clinical program quality audit planning, execution, and resolution of issues.
  • Schedule and lead regular Quality Management Reviews on the status of compliance, Quality Metrics, and Quality Standards for facilities, processes, procedures, and practices.
  • Provide quality oversight of GMP documentation including master batch records, validation protocols, and QC test methods.
  • Lead regulatory inspections and represent Hibio at supplier inspections, as appropriate.
  • Handle product complaints, changes, and deviations; lead or support investigations to resolve quality issues.
  • Oversee and implement the execution of GXP and SOP training programs; maintain centralized system for GXP documents including record control, archival, protection, and access.
  • Develop the Quality Assurance operating budget and monitor expenditures.
  • Identify GXP and other key compliance requirements and provide leadership in promoting awareness and understanding of global regulatory compliance expectations.
  • Lead the Audit Program management process, including assessment of internal and external (outsourced) GXP operations.
  • Work with cross-functional and other internal project teams to effectively support process and quality enhancement initiatives.
  • In collaboration with the CMC group, manage the approval process for raw materials, packaging materials, intermediate, and finished products as per the appropriate regulations and site procedures.
  • In collaboration with the CMC group, provide quality oversight into the testing program for materials and products, including the stability monitoring programs.
  • Partner with senior management to ensure that best practices and proper training are adopted, including compliance with all quality policies, quality improvement initiatives, and ensuring appropriate quality systems are implemented and maintained.
  • Ensure quality data integrity and CDMO manufactured products meet Health Authority regulations and company standards.
Requirements:
  • Bachelor's degree or advanced degree (preferred) in a scientific field.
  • Minimum of 15+ years quality experience in a biotech/pharma environment with at least 5-7 years as the functional head of quality.
  • Extensive knowledge of regulatory requirements, quality systems, inspections, audits, and all applicable FDA and EMA regulations and or guidance documents.
  • Experience in leading and managing regulatory inspections.
  • Strong working knowledge of GMP/GCP principles.
  • Hands-on experience with implementing and managing Quality/Compliance systems and processes.
  • Ability to work in a dynamic, start-up organization with aggressive timelines and multiple deliverables.
  • Possesses professional communication skills, strong independent time management skills, and the ability to manage multiple projects concurrently in an organized fashion.
  • An established history of partnering and managing quality business objectives with CMO/CDMOs.
  • Experience selecting and overseeing Qualified Persons (QPs) for product quality objectives and product release per geographical requirements.
  • Able to travel domestically and internationally.

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