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Director, Quality Assurance at Cellares
South San Francisco, United States
Job Descrption
This individual will be responsible to lead and grow the site Quality Assurance group and to ensure that the Quality management system and all aspects of cGMP are effectively established, implemented and maintained in accordance with the regulations. This is a multidisciplinary role & this individual will interface across many parts of the company.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
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
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)
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills
- 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.
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
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