Director, Quality Assurance

Location
South San Francisco, CA, United States
Posted
Nov 06, 2020
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Head of Quality: Position Summary and Responsibilities

The Director of Quality Assurance will be responsible for implementing and leading all Quality programs and ensuring compliance with all relevant domestic and international regulatory guidelines as they pertain to Neurona's cell-based product candidates.
  • Drive the development of the company's Quality strategy and policies.
  • Oversee company-wide documentation practices, record keeping, training, auditing, raw material qualification and risk assessment, SOPs, batch records, study protocols, reports, investigations, analytical methods, and release specifications.
  • Lead quality management systems efforts for the compliant manufacturing of lead product candidates. Responsible for release or rejection of GMP cell banks, and products.
  • Managing raw material/reagent program including schedule for sample testing in collaboration with internal and external testing labs to meet release times in support of manufacturing operations.
  • Develops, implements, and maintains Learning Management systems, programs and processes to ensure compliance with GMP
  • Provide Quality Assurance and compliance oversight for contract manufacturers and research organizations to ensure products/deliverables meet all required quality standards and specifications.
  • Collaborate with other department heads of Process Development and Manufacturing, Preclinical Development, and Regulatory Affairs to implement proper documentation, maintain compliance, and accelerate product candidates for clinical testing.
  • Draft, review, and approve relevant sections of regulatory filings.
  • Represent QA department at project and leadership team meetings.


Requirements
  • BS Degree in related area. Advanced degree preferred
  • 10+ years of experience in Quality Assurance at an operational/management level supporting manufacturing and quality control in a pharmaceutical or biotech environment.
  • Experience contributing to and reviewing regulatory filings.
  • Experience with cell and gene therapies, and full understanding of FDA CBER/OTAT guidance documents and requirements.
  • In-depth knowledge of pharmaceutical GMPs and ISOs (US and EU).
  • Prior experience implementing quality systems and advancing novel therapeutics from preclinical stages through IND to BLA is desired.
  • Effectively managed FDA inspections/audits, and conducted supplier/manufacturer audits.
  • Must have excellent verbal, written, and interpersonal communication and presentation skills.
  • Demonstrated ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive