Quality Assurance Manager

1 day ago

Boston, Massachusetts, United States KMR Search Group Full time
Job Title: Quality Assurance Manager

At KMR Search Group, we are seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for designing, planning, implementing, and evaluating a quality assurance function and a quality management system that supports clinical development and regulatory approval of products.

This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project management, Regulatory Affairs, Supply Chain, and CMOs. You will be responsible for developing, implementing, maintaining, and continually assessing a quality assurance function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements.

Key Responsibilities:
  • Develop and implement quality assurance processes and procedures
  • Administer policies and standard operating procedures (SOPs) relating to the quality assurance function and the quality management system
  • Establish and maintain a document control system for procedures, work instructions, and forms
  • Manage deviation and change control programs
  • Assist with executing appropriate quality training for the team
  • Quality oversight of IT systems used to support Quality activities, including Veeva, document management, and Quality training
  • Gather relevant information and author reports related to Annual Product Reviews
  • Review of CMC sections for regulatory submissions
  • Assist during regulatory inspections
  • Conduct incident investigations and identify related Corrective and Preventive Action (CAPA) activities and processes
  • Perform internal quality auditing (including applicable vendors or subcontractors), customer quality audit response, and other quality management system activities
  • Execute Vendor management program
  • Implement short-term and long-term strategies, goals, and objectives related to the quality assurance function and the quality management system
  • Review corrective actions to ensure consistency with the quality assurance function and the quality management system
  • Implement a continuous improvement plan for growing and maturing the quality assurance function and the quality management system
Requirements:
  • Bachelor's Degree in Biological sciences, Engineering, or related degree
  • Minimum of 5 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry
  • Ideally a minimum of 3 years of experience in leading a Quality function, preferably at the manager/supervisor level
  • Proven ability to effectively develop, communicate, and gain support for execution plans with Team members from other functions
  • Management skills to grow and manage a high-performing Quality organization
  • Demonstrated skills in project management and working with vendors and contractors
  • Background in FDA, ISO, EMA, GMP, and ICH requirements ideally for ATMPs
  • Familiar with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections
  • Ability to work in a fast-paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables

We are looking for a highly motivated and experienced Quality Assurance Manager to join our team. If you have a strong background in quality assurance and a passion for delivering high-quality products, we encourage you to apply for this exciting opportunity.

  • Quality Assurance Manager

    2 weeks ago

    Boston, Massachusetts, United States Diverse Lynx Full time

    Job DescriptionAs a QA Lead at Diverse Lynx LLC, you will play a crucial role in ensuring the quality of our software products. Your primary responsibility will be to design, develop, and execute test plans and test cases to identify and document defects.Key Responsibilities:Review requirements, specifications, and technical design documents to provide...

  • Quality Assurance and Facilities Manager

    2 weeks ago

    Boston, Massachusetts, United States Action for Boston Community Development, Inc., (ABCD) Full time

    Job Title: Quality Assurance and Facilities ManagerThe Quality Assurance and Facilities Manager serves as the lead on Head Start Center facilities-related projects and oversees center compliance with applicable local, state, federal, and association standards and regulations. This position is responsible for promoting the mission of ABCD Head Start &...

  • Software Quality Assurance Manager

    2 weeks ago

    Boston, Massachusetts, United States Diverse Lynx Full time

    Job DescriptionAt Diverse Lynx LLC, we are seeking a highly skilled Software Quality Assurance Manager to join our team.Key Responsibilities:Review requirements, specifications, and technical design documents to provide timely and meaningful feedback.Create detailed, comprehensive, and well-structured test plans and test cases.Estimate, prioritize, plan, and...

  • Software Quality Assurance Manager

    5 days ago

    Boston, Massachusetts, United States Clarivate Full time

    Software Quality Operations ManagerWe are seeking a highly skilled and experienced Software Quality Operations Manager to join our dynamic team at Clarivate.The ideal candidate will be responsible for leading and managing the QA team to ensure the highest quality standards for our software products.This role requires a deep understanding of software...

  • Quality Assurance Lead

    1 week ago

    Boston, Massachusetts, United States ApTask Full time

    About ApTask:ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management....

  • Quality Assurance Specialist

    3 weeks ago

    Boston, Massachusetts, United States Katalyst HealthCares & Life Sciences Full time

    Job SummaryKatalyst HealthCares & Life Sciences is seeking a highly skilled Quality Assurance Specialist to lead our quality assurance activities and ensure the highest levels of quality in our products.Key ResponsibilitiesTechnical Leadership: Provide technical leadership and direction in quality assurance, quality control, and preventative activities to...

  • Quality Assurance Specialist

    2 weeks ago

    Boston, Massachusetts, United States Arcaea Full time

    {"h1": "Quality Assurance Specialist at Arcaea", "p": "Arcaea is a biology-first beauty company that is revolutionizing the beauty and personal care industry with pioneering ingredients, products, and stories accessible uniquely through biology. We are seeking an experienced Quality Assurance Specialist to join our team and play a critical role in developing...

  • Quality Assurance Manager

    1 day ago

    Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job Title: Tech Transfer and Process Validation Quality ManagerJob Summary:The Quality Manager will provide advanced technical support in Quality Assurance and compliance, specifically in process validation and technical transfers. This role will coordinate or execute activities on multiple complex projects and take a lead role in the design and execution of...

  • Quality Assurance Coordinator

    3 weeks ago

    Boston, Massachusetts, United States LSG Sky Chefs Full time

    Job SummaryWe are seeking a detail-oriented and proactive Quality Assurance Coordinator to join our team at LSG Sky Chefs. As a key member of our Quality Assurance Department, you will be responsible for maintaining accurate records and key performance indicators, ensuring compliance with regulatory agencies, and meeting the needs of internal and airline...

  • Software Quality Assurance Manager

    3 weeks ago

    Boston, Massachusetts, United States Diverse Lynx Full time

    Job DescriptionAt Diverse Lynx LLC, we are seeking a highly skilled Quality Assurance Lead to join our team. As a key member of our software development process, you will be responsible for ensuring the highest quality of our products.Key ResponsibilitiesReview and provide feedback on technical design documents and requirements specificationsDevelop and...

  • Quality Assurance Coordinator

    3 weeks ago

    Boston, Massachusetts, United States LSG Sky Chefs Full time

    Job SummaryWe are seeking a detail-oriented and proactive Quality Assurance Coordinator to join our team at LSG Sky Chefs. As a key member of our Quality Assurance Department, you will be responsible for maintaining accurate records and key performance indicators, ensuring compliance with regulatory agencies, and meeting the needs of internal and airline...

  • Quality Assurance Coordinator

    3 weeks ago

    Boston, Massachusetts, United States LSG Sky Chefs Full time

    Job SummaryWe are seeking a detail-oriented and proactive Quality Assurance Coordinator to join our team at LSG Sky Chefs. As a key member of our Quality Assurance Department, you will be responsible for maintaining accurate records and key performance indicators, ensuring compliance with regulatory agencies, and meeting the needs of internal and airline...

  • Quality Assurance Coordinator

    3 weeks ago

    Boston, Massachusetts, United States LSG Sky Chefs Full time

    Job SummaryWe are seeking a detail-oriented and proactive Quality Assurance Coordinator to join our team at LSG Sky Chefs. As a key member of our Quality Assurance Department, you will be responsible for maintaining accurate records and key performance indicators, ensuring compliance with regulatory agencies, and meeting the needs of internal and airline...

  • Quality Assurance Manager

    2 weeks ago

    Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job DescriptionGeneral Position Summary:The Quality Manager is a senior technical resource in the principles and application of Quality Assurance and compliance, specifically in process validation and technical transfers. This role coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects.The...

  • Quality Assurance Specialist

    3 weeks ago

    Boston, Massachusetts, United States The Middlesex Corporation Full time

    About The Middlesex CorporationThe Middlesex Corporation is a leading heavy civil construction company with a strong reputation for delivering high-quality projects. As a Quality Assurance Specialist, you will play a critical role in ensuring the successful implementation of our quality standards and processes across various infrastructure projects.Job...

  • Quality Assurance Coordinator

    3 weeks ago

    Boston, Massachusetts, United States LSG Sky Chefs Full time

    Job SummaryWe are seeking a detail-oriented and proactive Quality Assurance Coordinator to join our team at LSG Sky Chefs. As a key member of our Quality Assurance Department, you will be responsible for maintaining accurate records and key performance indicators, ensuring compliance with regulatory agencies, and meeting the needs of internal and airline...

  • Quality Assurance Specialist

    3 weeks ago

    Boston, Massachusetts, United States Katalyst HealthCares & Life Sciences Full time

    Quality Assurance SpecialistAt Katalyst HealthCares & Life Sciences, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the highest levels of quality in our products and processes.Key Responsibilities:Lead design for manufacture and assembly through...

  • Quality Assurance Coordinator

    3 weeks ago

    Boston, Massachusetts, United States LSG Sky Chefs Full time

    Job SummaryWe are seeking a detail-oriented and organized Quality Assurance Coordinator to join our team at LSG Sky Chefs. The successful candidate will be responsible for maintaining accurate records and key performance indicators for the Quality Assurance Department and GQS. This includes monitoring food safety, sanitation, and compliance with regulatory...

  • Quality Assurance Coordinator

    2 weeks ago

    Boston, Massachusetts, United States LSG Sky Chefs Full time

    Job Title: Quality Assurance CoordinatorWe are seeking a highly skilled and detail-oriented Quality Assurance Coordinator to join our team at LSG Sky Chefs. As a key member of our Quality Department, you will be responsible for maintaining comprehensive recordkeeping and key performance indicators for the Quality Assurance Department and GQS.Main...

  • Quality Assurance Consultant

    3 weeks ago

    Boston, Massachusetts, United States Slalom Full time

    About the RoleWe are seeking a highly skilled Quality Assurance professional to join our team at Slalom. As a Quality Assurance Consultant, you will play a critical role in ensuring the delivery of high-quality solutions to our clients.Key ResponsibilitiesEvaluate and address complex client needs as part of a programCreate a shared understanding of business...