Senior Quality Assurance Manager

2 weeks ago


Reston, Virginia, United States Meet Full time
Senior Quality Assurance Manager

Meet our client, a pioneering biotech company dedicated to developing cutting-edge therapies. We are seeking a dynamic and hands-on Senior Quality Assurance Manager to lead and manage our QA activities.

Key Responsibilities:
  • Develop and implement an effective Quality Management System that aligns with regulatory standards, ensuring compliance with FDA, EMA, and ICH requirements.
  • Oversee the management of SOPs, ensuring they are current, effective, and properly implemented, with a focus on GxP compliance in GMP, GCP, and GLP environments.
  • Lead preparation and management of regulatory inspections and audits, providing QA oversight for all clinical trials, including the review and approval of study protocols, clinical trial agreements, and informed consent documents.
  • Monitor and audit clinical trial sites, CROs, and other vendors to ensure compliance with study protocols and regulatory requirements, investigating and resolving any quality issues or deviations in clinical trials.
  • Collaborate closely with R&D, manufacturing, and clinical teams to ensure quality is integrated into the development process, providing QA support for CMC activities, including batch record review and release, stability testing, and validation.
  • Lead and mentor a small QA team, fostering a culture of quality and continuous improvement, developing and implementing training programs to ensure all staff are aware of and comply with quality standards.
  • Identify and implement opportunities for process improvements to enhance quality and efficiency, staying current with industry best practices and regulatory changes, incorporating them into the QA processes as appropriate.
Requirements:
  • Bachelor's degree in Life Sciences, Biotechnology, or a related field, with an advanced degree preferred.
  • Minimum of 8-10 years of experience in Quality Assurance within the biotech or pharmaceutical industry, with a focus on clinical-stage products, demonstrating experience with GxP compliance, particularly in GMP, GCP, and GLP environments.
  • Proven track record of leading regulatory inspections and audits, with hands-on experience with QMS implementation and management in a small to mid-sized organization.


  • Reston, Virginia, United States JBAndrews Full time

    Job Title: Senior Quality Assurance ManagerLocation: Florida, USA.The RoleWe are seeking a highly skilled Senior Quality Assurance Manager to join our team at JBAndrews in Florida. As a key member of our organization, you will be responsible for ensuring the quality of our products and services.This is an exciting opportunity to work with a fast-growing...


  • Reston, Virginia, United States Randstad USA Full time

    {"Job Title": "Senior Quality Assurance Specialist", "Job Summary": "We are seeking a Senior Quality Assurance Specialist to maintain supplier performance metrics, develop trend data of supplier-related processes, log and track supplier quality events utilizing Quality System, and conduct audits of external suppliers for Positron Emission Tomography (PET)...


  • Reston, Virginia, United States Ultra Clean Technology Full time

    Unlock Your Potential at Ultra Clean TechnologyWe are seeking a seasoned Senior Director of Quality Assurance to lead our quality assurance strategies across multiple sites in the United States. This role requires a strategic leader with a proven track record in managing multi-site quality assurance systems and a deep commitment to continuous quality...


  • Reston, Virginia, United States DSJ Global Full time

    Job Title: Senior Quality Assurance SpecialistAbout Us: DSJ Global is a global leader in the chemical solutions industry, committed to advancing the field through innovation, sustainability, and excellence. We provide high-purity chemicals and advanced solutions to various sectors, including semiconductor manufacturing, pharmaceuticals, and...


  • Reston, Virginia, United States IntePros Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at IntePros. As a key member of our organization, you will be responsible for ensuring the quality of our products and services.Key ResponsibilitiesQuality Control and AssuranceDevelop and implement quality control procedures to ensure compliance with regulatory...


  • Reston, Virginia, United States Harba Solutions Inc. Full time

    Job Summary:Harba Solutions Inc. is seeking a highly skilled Senior Quality Assurance Consultant to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our pharmaceutical manufacturing processes.Key Responsibilities:Develop and implement quality assurance...


  • Reston, Virginia, United States Randstad Life Sciences US Full time

    Job Title: Senior Quality AnalystJob Summary:We are seeking a highly skilled Senior Quality Analyst to join our team at Randstad Life Sciences US. As a key member of our quality assurance team, you will be responsible for maintaining supplier performance metrics, developing trend data of supplier-related processes, and conducting audits of external suppliers...


  • Reston, Virginia, United States Medix™ Full time

    Job Title: Quality Assurance and Compliance ManagerMedix™ is seeking a highly experienced Quality Assurance and Compliance Manager to join our team. As a key member of our leadership team, you will be responsible for maintaining high standards of quality, compliance, and regulatory adherence across our GLP operations.This leadership role requires extensive...


  • Reston, Virginia, United States BAKKAVOR USA Full time

    About Bakkavor USAWe are the leaders in the fresh prepared food manufacturing industry, with a strong presence in the US and a global reputation for quality and innovation. Our mission is to develop and produce innovative, commercially successful, great-tasting food that offers choice, convenience, and freshness to people around the world.Job SummaryThe...


  • Reston, Virginia, United States Randstad USA Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Randstad USA. As a key member of our quality assurance team, you will be responsible for maintaining supplier performance metrics, developing trend data of supplier-related processes, and conducting audits of external suppliers.Key ResponsibilitiesReview and...


  • Reston, Virginia, United States Insight Global Full time

    Job SummaryInsight Global is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our products and services.Key ResponsibilitiesConduct analytical testing of raw materials, in-process, and final products to ensure compliance...


  • Reston, Virginia, United States Laguna Source Full time

    Job SummaryLaguna Source is seeking a highly experienced Senior Manager, Biopharma IT Quality Assurance to lead our newly established IT QA group within a cutting-edge biologics manufacturing facility. As part of a leading Global Contract Manufacturing Organization (CMO), you will be responsible for overseeing the digitalization efforts and ensuring...


  • Reston, Virginia, United States Lumicity Full time

    Job SummaryLumicity is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality team, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.ResponsibilitiesDevelop and implement quality systems and programs to ensure compliance with relevant...


  • Reston, Virginia, United States Averro Full time

    Quality Assurance ManagerAverro is seeking a highly skilled Quality Assurance Manager to lead our quality assurance program and ensure the highest standards of quality in our products.Key Responsibilities:Develop and implement quality assurance objectives and policies aligned with corporate goals.Conduct quality engineering reviews of design and purchasing...


  • Reston, Virginia, United States DSJ Global Full time

    DSJ Global is seeking a Quality Assurance Manager to join their team in Alabama. The successful candidate will be responsible for overseeing the quality assurance activities for the plant, ensuring compliance with local, state, and federal regulations. Key responsibilities include addressing complaints, building associate morale, and overseeing the Hazard...


  • Reston, Virginia, United States VRS Recruitment (US) Full time

    Quality Assurance ManagerVRS Recruitment (US) is seeking a Quality Assurance Manager to oversee and manage quality control, quality assurance, and quality improvement within a contract research organization in New Hampshire.Key ResponsibilitiesEnsure regulatory compliance (e.g., GxP and CLIA) within the company and review and implement quality...


  • Reston, Virginia, United States DSJ Global Full time

    Quality Assurance ManagerDSJ Global is seeking a dedicated and passionate Quality Assurance Manager to lead our quality team on the night shift. As a key member of our team, you will be responsible for ensuring the highest standards of quality and safety in our food manufacturing processes.Key Responsibilities:Facilitate effective communication within the...


  • Reston, Virginia, United States Kuhn North America, Inc. Full time

    Quality Assurance ManagerThe Quality Assurance Manager plays a pivotal role in ensuring the highest quality products at Kuhn North America, Inc. This position is responsible for developing and managing the overall Quality Assurance Program, driving process and procedure compliance, and fostering a culture of continuous improvement.Key...


  • Reston, Virginia, United States Terumo Medical Corporation Full time

    Job Title: Quality Assurance ManagerTerumo Medical Corporation is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality team, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our manufacturing processes.Key Responsibilities:Develop...


  • Reston, Virginia, United States Averro Full time

    About the RoleAverro is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for planning, coordinating, and directing the quality assurance program to ensure the production of high-quality products that meet established standards.Key ResponsibilitiesFormulate and maintain quality...