American Cell Technology
Location:
Sunrise, FL / Oakland Park, FL Employment Type:
Full-Time, Onsite Company:
American Cell Technology, the nation's largest personal mesenchymal stem cell bank Job Summary
American Cell Technology is seeking an experienced Quality Assurance Manager to oversee the quality assurance processes for our mesenchymal stem cell banking operations. The successful candidate will be responsible for developing, implementing, and maintaining robust quality assurance systems to ensure compliance with current Good Manufacturing Practices (cGMP), current Good Tissue Practices (cGTP), FDA regulations, and ISO standards. This role demands exceptional leadership, expertise in quality systems, and strong analytical skills to uphold the highest standards of product quality and regulatory compliance in a dynamic, innovative environment. Key Responsibilities
Quality Assurance Oversight : Design, implement, and manage comprehensive quality assurance systems to ensure product safety, purity, and efficacy in compliance with cGMP, cGTP, and ISO standards (e.g., ISO 13485, ISO 9001). Regulatory Compliance : Ensure adherence to FDA regulations (e.g., 21 CFR Parts 210, 211, 1271) and other relevant standards through proactive risk assessments, internal audits, and robust documentation practices. Process Validation and Risk Management : Develop and oversee process validation protocols, perform risk assessments, and implement quality risk management strategies to ensure consistent production and compliance. Quality System Development : Establish, maintain, and continuously improve quality management systems, including the development and revision of Standard Operating Procedures (SOPs), quality manuals, and training programs. Team Leadership and Development : Lead, mentor, and train a team of quality assurance professionals, fostering a culture of accountability, collaboration, and continuous improvement. Audits and Inspections : Plan and conduct internal and external audits, manage regulatory inspections, and coordinate corrective and preventive actions (CAPAs) to address non-conformances. Documentation and Reporting : Oversee the creation and maintenance of accurate quality records, including audit reports, deviation reports, and CAPA documentation, to ensure traceability and inspection readiness. Continuous Improvement : Drive initiatives for process optimization, leveraging data analysis and quality metrics to identify trends, reduce risks, and enhance quality outcomes. Cross-Functional Collaboration : Partner with manufacturing, regulatory affairs, and R&D teams to align quality assurance processes with operational and developmental goals, ensuring seamless integration and compliance. Change Control and Deviation Management : Manage change control processes, investigate deviations, and implement corrective actions to maintain quality standards and prevent recurrence. Qualifications
Education : Bachelor’s degree in a life sciences field (e.g., Biology, Biochemistry, Biotechnology); Master’s degree or higher preferred, with a focus on quality management or regulatory affairs. Experience : Minimum of 5-10 years of experience in quality assurance within a cGMP/cGTP-regulated environment, including 1-3 years in a supervisory or leadership role; preferably in cell therapy, biologics, or stem cell banking. Regulatory Knowledge : In-depth understanding of FDA regulations (e.g., 21 CFR Parts 210, 211, 1271) and ISO standards (e.g., ISO 13485, ISO 9001), including experience with regulatory inspections and compliance audits. Quality Systems Expertise : Proven experience in developing, implementing, and maintaining quality management systems (QMS), including risk management, change control, and deviation investigations. Process Validation and Risk Management : Demonstrated expertise in designing, executing, and overseeing process validation protocols, along with quality risk management strategies in a regulated environment. Leadership and Development : Strong track record of managing, leading and mentoring QA teams, with excellent interpersonal, communication, and training skills to foster a culture of continuous improvement. Technical Skills : Proficiency in QMS software, data analysis for quality metrics, audit planning, and CAPA implementation; familiarity with biotechnology processes in a regulated setting. Certifications : Quality-related certifications (e.g., ASQ Certified Quality Manager, ASQ Certified Quality Auditor, Six Sigma) are highly desirable. Skills : Exceptional time management, analytical, problem-solving, and decision-making abilities; capacity to thrive in a fast-paced, high-pressure regulated environment while prioritizing compliance and quality. Compensation
Base Salary:
$70,000 - $100,000 per year, commensurate with experience and qualifications. Bonus:
Performance-based annual bonus potential of up to 15% of base salary, tied to quality metrics and team performance. Comprehensive health, dental, and vision insurance. 401(k) with company match. Paid time off (PTO) and holidays. Professional development and certification reimbursement. Relocation assistance (if applicable). Full-time, onsite position at our Oakland Park, FL facility. Collaborative and innovative workplace with opportunities for career growth.
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Sunrise, FL / Oakland Park, FL Employment Type:
Full-Time, Onsite Company:
American Cell Technology, the nation's largest personal mesenchymal stem cell bank Job Summary
American Cell Technology is seeking an experienced Quality Assurance Manager to oversee the quality assurance processes for our mesenchymal stem cell banking operations. The successful candidate will be responsible for developing, implementing, and maintaining robust quality assurance systems to ensure compliance with current Good Manufacturing Practices (cGMP), current Good Tissue Practices (cGTP), FDA regulations, and ISO standards. This role demands exceptional leadership, expertise in quality systems, and strong analytical skills to uphold the highest standards of product quality and regulatory compliance in a dynamic, innovative environment. Key Responsibilities
Quality Assurance Oversight : Design, implement, and manage comprehensive quality assurance systems to ensure product safety, purity, and efficacy in compliance with cGMP, cGTP, and ISO standards (e.g., ISO 13485, ISO 9001). Regulatory Compliance : Ensure adherence to FDA regulations (e.g., 21 CFR Parts 210, 211, 1271) and other relevant standards through proactive risk assessments, internal audits, and robust documentation practices. Process Validation and Risk Management : Develop and oversee process validation protocols, perform risk assessments, and implement quality risk management strategies to ensure consistent production and compliance. Quality System Development : Establish, maintain, and continuously improve quality management systems, including the development and revision of Standard Operating Procedures (SOPs), quality manuals, and training programs. Team Leadership and Development : Lead, mentor, and train a team of quality assurance professionals, fostering a culture of accountability, collaboration, and continuous improvement. Audits and Inspections : Plan and conduct internal and external audits, manage regulatory inspections, and coordinate corrective and preventive actions (CAPAs) to address non-conformances. Documentation and Reporting : Oversee the creation and maintenance of accurate quality records, including audit reports, deviation reports, and CAPA documentation, to ensure traceability and inspection readiness. Continuous Improvement : Drive initiatives for process optimization, leveraging data analysis and quality metrics to identify trends, reduce risks, and enhance quality outcomes. Cross-Functional Collaboration : Partner with manufacturing, regulatory affairs, and R&D teams to align quality assurance processes with operational and developmental goals, ensuring seamless integration and compliance. Change Control and Deviation Management : Manage change control processes, investigate deviations, and implement corrective actions to maintain quality standards and prevent recurrence. Qualifications
Education : Bachelor’s degree in a life sciences field (e.g., Biology, Biochemistry, Biotechnology); Master’s degree or higher preferred, with a focus on quality management or regulatory affairs. Experience : Minimum of 5-10 years of experience in quality assurance within a cGMP/cGTP-regulated environment, including 1-3 years in a supervisory or leadership role; preferably in cell therapy, biologics, or stem cell banking. Regulatory Knowledge : In-depth understanding of FDA regulations (e.g., 21 CFR Parts 210, 211, 1271) and ISO standards (e.g., ISO 13485, ISO 9001), including experience with regulatory inspections and compliance audits. Quality Systems Expertise : Proven experience in developing, implementing, and maintaining quality management systems (QMS), including risk management, change control, and deviation investigations. Process Validation and Risk Management : Demonstrated expertise in designing, executing, and overseeing process validation protocols, along with quality risk management strategies in a regulated environment. Leadership and Development : Strong track record of managing, leading and mentoring QA teams, with excellent interpersonal, communication, and training skills to foster a culture of continuous improvement. Technical Skills : Proficiency in QMS software, data analysis for quality metrics, audit planning, and CAPA implementation; familiarity with biotechnology processes in a regulated setting. Certifications : Quality-related certifications (e.g., ASQ Certified Quality Manager, ASQ Certified Quality Auditor, Six Sigma) are highly desirable. Skills : Exceptional time management, analytical, problem-solving, and decision-making abilities; capacity to thrive in a fast-paced, high-pressure regulated environment while prioritizing compliance and quality. Compensation
Base Salary:
$70,000 - $100,000 per year, commensurate with experience and qualifications. Bonus:
Performance-based annual bonus potential of up to 15% of base salary, tied to quality metrics and team performance. Comprehensive health, dental, and vision insurance. 401(k) with company match. Paid time off (PTO) and holidays. Professional development and certification reimbursement. Relocation assistance (if applicable). Full-time, onsite position at our Oakland Park, FL facility. Collaborative and innovative workplace with opportunities for career growth.
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