Quality Site Head
3 weeks ago
Rx Group is recruiting a quality director, site head for a clinical-stage biotech based in Florida.
Job Summary:
The successful candidate will play a pivotal role in ensuring the highest standards of quality, compliance, and regulatory adherence throughout clinical-stage gene therapy operations. Reporting to the Vice President of Quality, the Site Quality Assurance Director will be responsible for overseeing all aspects of quality assurance activities, driving continuous improvement initiatives, and fostering a culture of quality excellence within the organization.
Key Responsibilities:
Leadership: Provide strategic leadership and direction to the site quality assurance team, fostering a collaborative and high-performance culture focused on quality and compliance.
Quality Management Systems (QMS): Develop, implement, and maintain robust quality management systems in accordance with applicable regulations and industry standards (e.g., FDA, EMA, ICH).
Regulatory Compliance: Ensure compliance with relevant regulatory requirements, guidelines, and standards for clinical-stage gene therapy products, including GxP, ICH, and cGMP.
Audits and Inspections: Plan and coordinate internal and external audits, inspections, and assessments, driving timely resolution of findings and implementation of corrective/preventive actions.
Document Control: Oversee document control processes, including document creation, review, approval, distribution, and retention, to ensure accuracy, completeness, and compliance.
Training and Development: Implement training programs to ensure staff competency in quality and regulatory requirements, promoting a culture of continuous learning and development.
Risk Management: Lead risk assessment activities to identify, evaluate, and mitigate quality and compliance risks associated with gene therapy manufacturing and testing processes.
Supplier Quality Management: Collaborate with cross-functional teams to establish and maintain robust supplier quality management programs, including supplier qualification, audits, and performance monitoring.
Continuous Improvement: Drive continuous improvement initiatives to enhance quality systems, processes, and procedures, leveraging data-driven approaches and best practices.
Communication: Serve as the primary point of contact for quality assurance-related matters, providing regular updates, reports, and presentations to senior management and stakeholders.
Qualifications:
Bachelor's degree in life sciences, engineering, or a related field; advanced degree preferred.
Minimum of 8-10 years of experience in quality assurance roles within the Pharma & Biotech industry, with at least 5 years in a director level position.
In-depth knowledge of global regulatory requirements and guidelines for cell and gene therapy products highly beneficial.
Strong understanding of quality management systems (QMS), quality risk management principles, and Good Manufacturing Practices (GMP).
Proven track record of successfully leading and managing quality assurance teams in biotech OR CDMO's.
Excellent communication, interpersonal, and leadership skills, with the ability to influence and collaborate effectively across functions and levels of the organization.
Results-oriented mindset with a focus on continuous improvement and problem-solving.
Please apply directly or contact Hemish Ilangaratne at h.ilangaratne@rx-group.io for further information.
#J-18808-Ljbffr
-
Senior Quality Manager
2 weeks ago
Tallahassee, United States CEVA Logistics Full timeYOUR ROLE This role will primarily focus driving the Quality Team to ensure implementation of Quality Management Systems and the drive the expected level of compliance. The role will also ensure appropriate KPI follow up while boosting continuous improvement culture within the organization and provide a suite of challenging metrics aligned with Global...
-
National Product Specialist
4 days ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside in LA, Denver, or Phoenix. Primary Duties Grow sales of VITEK REVEAL products and services in assigned territory in accordance with annual salesgrowth objectives.Sustain and grow product knowledge on VITEK REVEAL to be the technical subject matter expert and workcollaboratively with Account Managers to move...
-
Quality Assurance Analyst- Tallahassee, FL
1 week ago
Tallahassee, United States Georgia IT Inc Full timePosition: Quality Assurance Analyst Location: Tallahassee, FL Duration: Contract Rate: DOE (USC. GC holders are only preferred) Education: BS/ equivalent experience 6+ years of experience with testing and workload modeling across various technology platforms (web-based, web services, .NET, apps, etc.). 6+ years of experience test planning and defining...
-
Quality Assurance Analyst- Tallahassee, FL
3 days ago
Tallahassee, United States Georgia IT Inc Full timePosition: Quality Assurance Analyst Location: Tallahassee, FL Duration: Contract Rate: DOE (USC. GC holders are only preferred) Education: BS/ equivalent experience 6+ years of experience with testing and workload modeling across various technology platforms (web-based, web services, .NET, apps, etc.). 6+ years of experience test planning and defining...
-
National Product Specialist
1 week ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside in the DFW area. Primary Duties1. Grow sales of VITEK REVEAL products and services in assigned territory in accordance with annual sales growth objectives.2. Sustain and grow product knowledge on VITEK REVEAL to be the technical subject matter expert and work collaboratively with Account Managers to move...
-
Salesforce Platform Developer
1 week ago
Tallahassee, United States Kyra Solutions Full timeSummary/Objective: At Kyra Solutions, we implement business solutions for government workers with best-of-breed technology platforms. Our goal is to improve the effectiveness and quality of work life for state workers in capitals across the U.S. to help better the lives of citizens they serve. State agencies choose Kyra for our dedicated team of experts who...
-
Account Sales Manager- Indiana/Chicago Loop
4 weeks ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside in Indiana/Chicago loop area.The Account Manager is responsible for maintaining and growing the Microbiology, Immunoassay, Molecular and Vision Suite customer base. This role will focus on creating new business opportunities through the placement of instruments, reagents and services leading to increased revenues...
-
Account Sales Manager- New Orleans
4 weeks ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside within the New Orleans area.The Account Manager is responsible for maintaining and growing the Microbiology, Immunoassay, Molecular and Vision Suite customer base. This role will focus on creating new business opportunities through the placement of instruments, reagents and services leading to increased revenues...
-
Account Manager
2 days ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription Primary DutiesBusiness Development and Execution:Create and execute business plan to achieve or exceed territory growth per company plan and drive new business revenue through selling new instruments and reagents:Develop strategy and individual responsibilities to close sales of all high value targets.Maintain existing customer business to...
-
Salesforce Platform Developer
4 weeks ago
Tallahassee, United States Kyra Solutions Full timeSummary/Objective: At Kyra Solutions, we implement business solutions for government workers with best-of-breed technology platforms. Our goal is to improve the effectiveness and quality of work life for state workers in capitals across the U.S. to help better the lives of citizens they serve. State agencies choose Kyra for our dedicated team of experts who...
-
Salesforce Platform Developer
16 hours ago
Tallahassee, United States Kyra Solutions Full timeSummary/Objective: At Kyra Solutions, we implement business solutions for government workers with best-of-breed technology platforms. Our goal is to improve the effectiveness and quality of work life for state workers in capitals across the U.S. to help better the lives of citizens they serve. State agencies choose Kyra for our dedicated team of experts who...
-
Salesforce Platform Developer
4 weeks ago
Tallahassee, United States Kyra Solutions Full timeSummary/Objective: At Kyra Solutions, we implement business solutions for government workers with best-of-breed technology platforms. Our goal is to improve the effectiveness and quality of work life for state workers in capitals across the U.S. to help better the lives of citizens they serve. State agencies choose Kyra for our dedicated team of experts who...
-
Account Sales Manager- Little Rock
4 weeks ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside within the Little Rock, AR area.The Account Manager is responsible for maintaining and growing the Microbiology, Immunoassay, Molecular and Vision Suite customer base. This role will focus on creating new business opportunities through the placement of instruments, reagents and services leading to increased...
-
Account Sales Manager- Long Island/Queens
4 weeks ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside within Long Island/Queens.The Account Manager is responsible for maintaining and growing the Microbiology, Immunoassay, Molecular and Vision Suite customer base. This role will focus on creating new business opportunities through the placement of instruments, reagents and services leading to increased revenues for...
-
Account Sales Manager- Central NJ
4 weeks ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside within the Edison/Central NJ area.The Account Manager is responsible for maintaining and growing the Microbiology, Immunoassay, Molecular and Vision Suite customer base. This role will focus on creating new business opportunities through the placement of instruments, reagents and services leading to increased...
-
Account Sales Manager-Tulsa/Oklahoma City
4 weeks ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside within the Tulsa or Oklahoma City area.The Account Manager is responsible for maintaining and growing the Microbiology, Immunoassay, Molecular and Vision Suite customer base. This role will focus on creating new business opportunities through the placement of instruments, reagents and services leading to increased...
-
Account Sales Manager- Central NJ
1 day ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside within the Edison/Central NJ area. The Account Manager is responsible for maintaining and growing the Microbiology, Immunoassay, Molecular and Vision Suite customer base. This role will focus on creating new business opportunities through the placement of instruments, reagents and services leading to increased...
-
Account Manager- Washington, DC or Northern VA
4 weeks ago
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside within Washington, DC or Northern VA.The Account Manager is responsible for maintaining and growing the Microbiology, Immunoassay, Molecular and Vision Suite customer base. This role will focus on creating new business opportunities through the placement of instruments, reagents and services leading to increased...
-
Tallahassee, Florida, United States bioMerieux SA Career Site - MULTI-LINGUAL Full timeDescription The ideal candidate will reside within Washington, DC or Northern VA. The Account Manager is responsible for maintaining and growing the Microbiology, Immunoassay, Molecular and Vision Suite customer base. This role will focus on creating new business opportunities through the placement of instruments, reagents and services leading to increased...
-
Business Analyst
2 weeks ago
Tallahassee, United States Gravity IT Resources Full timeJob Title: Business AnalystLocation: Tallahassee, FL (Hybrid)Job Type: ContractReferral Fee:Employment Eligibility: Gravity cannot transfer nor sponsor a work visa for this position. Applicants must be eligible to work in the U.S. for any employer directly Duties and ResponsibilitiesFacilitate joint analysis workshops with the business units.Gather and...
