Azzur Group
Project Manager
Azzur Group, Columbus, Ohio, United States, 43224
About Us : Azzur Group is a leading consulting firm specializing in Commissioning, Qualification, and Validation (CQV) and Quality Assurance (QA)
services for the life sciences sector. Our expertise ensures that our clients’ facilities, equipment, and processes meet rigorous regulatory standards and operate efficiently. We are dedicated to delivering excellence through innovative solutions and exceptional client service. Join our team and be part of a company that drives compliance and operational excellence. Position Overview:
We are seeking an experienced Project Manager with a strong background in CQV and/or QA to lead and manage projects within our consulting services division. The Project Manager will be responsible for overseeing the successful delivery of CQV/QA projects, ensuring they are completed on time, within scope, and on budget. The ideal candidate will possess strong leadership skills, a deep understanding of QA and/or CQV principles, and excellent project management capabilities. Key Responsibilities: Project Leadership and Management: Lead and manage CQV and QA projects from initiation through completion, including planning, execution, and delivery. Develop project plans, timelines, and budgets, and ensure alignment with client requirements and company objectives. Coordinate and oversee all project activities, including commissioning, qualification, and validation of systems and processes, documentation updates, change control management, and calibration and metrology activities. Client and Stakeholder Engagement: Serve as the primary point of contact for clients, maintaining strong relationships and ensuring clear communication throughout the project lifecycle. Engage with stakeholders to define project scope, objectives, and deliverables. Address and resolve client issues, concerns, and changes effectively and promptly. Team Management: Lead and mentor project teams, including CQV engineers, consultants, and other personnel. Allocate resources and assign tasks to team members, ensuring effective utilization and performance. Monitor team progress, provide guidance, and support to ensure successful project outcomes. Compliance and Quality Assurance: Ensure that all CQV activities and deliverables adhere to industry regulations, standards, and best practices (e.g., FDA, EMA, GMP).. Ensure all deviations, nonconformances, LIRs, and CAPAs related to the project are opened, investigated, and closed in a timely manner to ensure compliance with regulatory requirements and project timelines. Ensure change controls are opened and managed to ensure compliance with regulatory requirements and project timelines. Track documentation updates and completion throughout the project lifecycle. Implement and enforce quality control measures to maintain high standards of project execution. Continuous Improvement: Identify opportunities for process improvements and contribute to the development of best practices and standard operating procedures (SOPs). Stay abreast of industry trends, regulatory changes, and technological advancements to enhance project management practices. Requirements Qualifications: Education: Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degrees are a plus. Experience: Minimum of 5-7 years of experience in project management with a focus on CQV/QA within the pharmaceutical, biotechnology, or medical device industries. Proven track record of successfully managing complex CQV/QA projects and delivering results on time and within budget. Skills: Strong knowledge of CQV principles, regulatory requirements, and industry standards. Excellent project management skills, including planning, execution, and risk management. Proficiency in project management tools and methodologies. Exceptional leadership, communication, and interpersonal skills. Ability to manage multiple projects simultaneously and work effectively under pressure. Certifications: Project Management Professional (PMP) or equivalent certification is preferred. QA/CQV-related certifications (e.g., ASQ Certified Quality Engineer) are a plus. Benefits Why Join Us: Competitive salary and benefits package. Opportunity to lead impactful projects in a collaborative and dynamic environment. Professional development and career advancement opportunities. Commitment to work-life balance and employee well-being. Azzur Group is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
services for the life sciences sector. Our expertise ensures that our clients’ facilities, equipment, and processes meet rigorous regulatory standards and operate efficiently. We are dedicated to delivering excellence through innovative solutions and exceptional client service. Join our team and be part of a company that drives compliance and operational excellence. Position Overview:
We are seeking an experienced Project Manager with a strong background in CQV and/or QA to lead and manage projects within our consulting services division. The Project Manager will be responsible for overseeing the successful delivery of CQV/QA projects, ensuring they are completed on time, within scope, and on budget. The ideal candidate will possess strong leadership skills, a deep understanding of QA and/or CQV principles, and excellent project management capabilities. Key Responsibilities: Project Leadership and Management: Lead and manage CQV and QA projects from initiation through completion, including planning, execution, and delivery. Develop project plans, timelines, and budgets, and ensure alignment with client requirements and company objectives. Coordinate and oversee all project activities, including commissioning, qualification, and validation of systems and processes, documentation updates, change control management, and calibration and metrology activities. Client and Stakeholder Engagement: Serve as the primary point of contact for clients, maintaining strong relationships and ensuring clear communication throughout the project lifecycle. Engage with stakeholders to define project scope, objectives, and deliverables. Address and resolve client issues, concerns, and changes effectively and promptly. Team Management: Lead and mentor project teams, including CQV engineers, consultants, and other personnel. Allocate resources and assign tasks to team members, ensuring effective utilization and performance. Monitor team progress, provide guidance, and support to ensure successful project outcomes. Compliance and Quality Assurance: Ensure that all CQV activities and deliverables adhere to industry regulations, standards, and best practices (e.g., FDA, EMA, GMP).. Ensure all deviations, nonconformances, LIRs, and CAPAs related to the project are opened, investigated, and closed in a timely manner to ensure compliance with regulatory requirements and project timelines. Ensure change controls are opened and managed to ensure compliance with regulatory requirements and project timelines. Track documentation updates and completion throughout the project lifecycle. Implement and enforce quality control measures to maintain high standards of project execution. Continuous Improvement: Identify opportunities for process improvements and contribute to the development of best practices and standard operating procedures (SOPs). Stay abreast of industry trends, regulatory changes, and technological advancements to enhance project management practices. Requirements Qualifications: Education: Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degrees are a plus. Experience: Minimum of 5-7 years of experience in project management with a focus on CQV/QA within the pharmaceutical, biotechnology, or medical device industries. Proven track record of successfully managing complex CQV/QA projects and delivering results on time and within budget. Skills: Strong knowledge of CQV principles, regulatory requirements, and industry standards. Excellent project management skills, including planning, execution, and risk management. Proficiency in project management tools and methodologies. Exceptional leadership, communication, and interpersonal skills. Ability to manage multiple projects simultaneously and work effectively under pressure. Certifications: Project Management Professional (PMP) or equivalent certification is preferred. QA/CQV-related certifications (e.g., ASQ Certified Quality Engineer) are a plus. Benefits Why Join Us: Competitive salary and benefits package. Opportunity to lead impactful projects in a collaborative and dynamic environment. Professional development and career advancement opportunities. Commitment to work-life balance and employee well-being. Azzur Group is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.