Full-Time

Director – Quality Assurance

Posted on 4/30/2024

Cellares

Cellares

51-200 employees

Integrated platform for cell therapy manufacturing

Data & Analytics
Hardware

Senior, Expert

San Bruno, CA, USA

Required Skills
Management
Quality Assurance (QA)
Requirements
  • Bachelor degree or higher in Life Sciences or related field
  • 10+ years of relevant experience in the pharmaceutical or biopharmaceutical industries, including 7 years of leadership experience, and demonstrated knowledge of relevant cGMP regulations
  • Experience with Cell and Gene Therapy products preferred
  • Experience in client-focused development and manufacturing organizations preferred
  • Demonstrated leadership with strong communication skills (both verbal and technical) and an ability to deliver results through teamwork
  • Must be able to analyze processes, lead improvement activities, and empower staff to create a lean culture in the laboratory
  • Demonstrated people management skills required
  • In-depth knowledge of Good Manufacturing Practices (GMPs)
  • In-depth knowledge of Quality principles, concepts, industry practices, and standards
  • Keen understanding of international quality control systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives
  • Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function
  • Self-motivated and passionate about advancing the field of cell therapies
  • Self-awareness, integrity, authenticity, and a growth mindset
Responsibilities
  • Lead cGMP compliance activities for all relevant operations including activities related to manufacturing, testing and release of preclinical and clinical cell and gene therapy products
  • Work closely with operation functions to enforce quality and regulatory requirements and provide quality oversight and leadership across these functions to assure compliance and strong relationships
  • Lead all quality aspects and deliverables of customers projects to ensure compliance and project progress
  • Manage all quality related interactions with customers from IND enabling studies to routine clinical GMP operations
  • Lead and host compliance audits including customer audits and health authorities/regulatory inspections
  • Lead batch record review, lot disposition, material release, internal audit program, deviation handling, CAPA, change controls and quality events processes
  • Lead the site Quality Management Review (QMR) and ensure the effectiveness of the Quality Management System
  • Oversee and support new product introduction, tech transfer and process and analytical qualification activities
  • Perform quality reviews and approval of all customers CMC/GMP documents needed for IND, BLA, CTA, etc.
  • Oversee quality aspects of commissioning, qualification and validation activities for the facilities, utilities equipment and computer validation
  • Review and approve Validation Master Plan, validation protocols and reports
  • Lead and drive risk assessments and the implementation of the contamination control program
  • Develop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed
  • Actively manage a group of QA personnel and oversee their performance management, mentoring, and career development in line with their strengths
  • Develop and manage departmental goals and corresponding budget in alignment with corporate vision and goals
  • Recruit talent and builds a high performance team; mentors and coaches colleagues

Cellares offers the Cell Shuttle, an integrated platform for cell therapy manufacturing, utilizing Industry 4.0 technologies to enable true walk-away, end-to-end automation, modular hardware, purpose-built process design software, and scalable manufacturing from preclinical to commercial scale, resulting in reduced process failure rates and up to 70% cost reduction compared to manual processes. The company aims to accelerate access to life-saving cell therapies by deploying Cell Shuttles in Smart Factories globally, partnering with academia, biotechs, and pharma companies to lower manufacturing costs and meet global patient demand.

Company Stage

Series C

Total Funding

$373M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights
Headcount

6 month growth

15%

1 year growth

43%

2 year growth

96%
INACTIVE