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Manager, Quality Assurance
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Director, Quality Assurance
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Cellares South San Francisco, United StatesWe are seeking a highly motivated collaborative Director of Quality Assurance for our South San Francisco location to develop, establish, implement and maintain a phase appropriate cGMP Quality management system for the Cell & Gene Therapy operations to support pre-clinical and c ...
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Quality Assurance Specialist
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Quality Assurance Manager
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Director, Quality Assurance
1 week ago
Cellares South San Francisco, United StatesWe are seeking a highly motivated collaborative Director of Quality Assurance for our South San Francisco location to develop, establish, implement and maintain a phase appropriate cGMP Quality management system for the Cell & Gene Therapy operations to support pre-clinical and c ...
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Quality Assurance Manager
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Shaw Bakers South San Francisco, United StatesAbout Shaw Bakers · At Shaw Bakers, we love mixing renowned French technics with state-of-the-art process innovation to bring delicious baked goods to our local community through our legendary local Cafes, as well as national retail partners across North America. We are an aggres ...
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Director, Quality Assurance
3 weeks ago
Cellares South San Francisco, United StatesWe are seeking a highly motivated collaborative Director of Quality Assurance for our South San Francisco location to develop, establish, implement and maintain a phase appropriate cGMP Quality management system for the Cell & Gene Therapy operations to support pre-clinical and c ...
Director, Quality Assurance - South San Francisco, CA, United States - Cellares
Description
South San Francisco, CAQuality – Quality /Full Time /On-siteWe are seeking a highly motivated collaborative Director of Quality Assurance for our South San Francisco location to develop, establish, implement and maintain a phase appropriate cGMP Quality management system for the Cell & Gene Therapy operations to support pre-clinical and clinical manufacturing.
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.
ResponsibilitiesLead cGMP compliance activities for all relevant operations including activities related to manufacturing, testing and release of preclinical and clinical cell and gene therapy productsWork 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 progressManage all quality related interactions with customers from IND enabling studies to routine clinical GMP operationsLead and host compliance audits including customer audits and health authorities/regulatory inspectionsLead batch record review, lot disposition, material release, internal audit program, deviation handling, CAPA, change controls and quality events processesLead the site Quality Management Review (QMR) and ensure the effectiveness of the Quality Management SystemOversee and support new product introduction, tech transfer and process and analytical qualification activitiesPerform 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 validationReview and approve Validation Master Plan, validation protocols and reportsLead and drive risk assessments and the implementation of the contamination control programDevelop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as neededActively manage a group of QA personnel and oversee their performance management, mentoring, and career development in line with their strengthsDevelop and manage departmental goals and corresponding budget in alignment with corporate vision and goalsRecruit talent and builds a high performance team; mentors and coaches colleaguesRequirementsBachelor degree or higher in Life Sciences or related field10+ years of relevant experience in the pharmaceutical or biopharmaceutical industries, including 7 years of leadership experience, and demonstrated knowledge of relevant cGMP regulationsExperience with Cell and Gene Therapy products preferredExperience in client-focused development and manufacturing organizations preferredDemonstrated leadership with strong communication skills (both verbal and technical) and an ability to deliver results through teamworkMust be able to analyze processes, lead improvement activities, and empower staff to create a lean culture in the laboratoryDemonstrated people management skills requiredIn-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 skillsIn-depth knowledge of Quality principles, concepts, industry practices, and standardsKeen understanding of international quality control systems regulations to adopt best in class systems/processes and drive continuous improvement initiativesDemonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the functionSelf-motivated and passionate about advancing the field of cell therapiesSelf-awareness, integrity, authenticity, and a growth mindset.$170,000 - $220,000 a yearCellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options.
All displayed pay ranges are approximate, negotiable, and location dependent.This is CellaresCellares 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.
