Senior Manager Quality Assurance

1 week ago


Rockville, Maryland, United States Raise Full time
Senior Manager Quality Engineering

Join a dynamic and high-profile team at a clinical-stage biopharmaceutical company with nearly a decade of experience. This innovative organization is at the forefront of developing groundbreaking technologies to combat cancer and other immunological diseases.

Responsibilities:
  • Evaluate the current status of VMP, including general CQV, CSV, and EMPQ to identify gaps, propose mitigation, and initiate remediation.
  • Work with site facility and operations teams to ensure compliance with Validation Master Plan activities.
  • Support facility qualification/commissioning and operations/preventative maintenance program.
  • Support and manage master equipment file.
  • Implement qualification and validation life cycle for both software and equipment (IQ, OQ, PQ).
  • Support the site quality system management with measurement and control strategies.
  • Manage the risk assessment process for qualification and validation.
  • Review technical/investigation reports as appropriate.
  • Write, review, and approve proposed changes to systems and procedures, as appropriate.
  • Write, review, and approve protocols and summary reports.
  • Perform other duties and tasks as assigned.
Qualifications:
  • Bachelor's degree in technical discipline (Computer Science/Industrial Engineering or similar).
  • Minimum of 7 years of Quality Engineering with related experience such as Computer System Validation in a GMP environment (Drug Substance or Drug Product).
  • Knowledge of quality systems and pharmaceutical regulatory requirements (21 CFR Part 11/210/211, ICH 8, ICH 9, and ICH 10).
  • Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.
  • Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).
  • Automation, equipment, and utility IQ/OQ/PQ/PV.
  • Quality Assurance, GMPs, Health Authority Regulations, and Validation practices/principles.
  • Strong knowledge of GMP, GAMP, SOPs, and quality systems.
  • Experience with internal and external audit principles.
  • Strong knowledge of change control practices/strategies.
  • Proficient in MS Word, Excel, PowerPoint, and other applications.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Strong communication and coordination skills, good language skills, and the ability to analyze and solve problems with a positive work attitude.

Raise is an established hiring firm with over 65 years of experience. We believe strongly in making the world a better place through work, which is why we're a certified B Corporation and donate 10% of our profits to charity.

We strive to build teams that reflect the diversity of the communities we work in. We encourage all qualified applicants to apply, including people from traditionally underrepresented groups such as women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI, veterans, and people with visible/nonvisible disabilities.

We have a dedicated webpage for accommodations where you can learn more about what we offer, and request accommodation.



  • Rockville, Maryland, United States Kolon TissueGene, Inc. Full time

    Job Title: Sr. Quality Assurance ManagerKolon TissueGene, Inc. is a pioneering biopharmaceutical company focused on regenerative medicine. We are seeking a highly skilled QA Manager/Senior Manager to lead and oversee our Quality Systems.Key Responsibilities:Collaborate with Manufacturing on product quality planning and improvementsConduct internal and...


  • Rockville, Maryland, United States Raise Full time

    Senior Manager Quality EngineeringWe are seeking a highly skilled Senior Manager Quality Engineering to join our team at Raise. As a key member of our organization, you will be responsible for leading the development and implementation of quality engineering strategies and initiatives.Key Responsibilities:Evaluate the current status of validation master...


  • Rockville, Maryland, United States Quality Agents Full time

    Job OverviewQuality Agents is a leading service company that provides validation and quality expertise to the pharmaceutical and biotechnology industries. We are seeking a highly skilled professional to join our team as a Quality Assurance Specialist.Key ResponsibilitiesDevelop and implement quality assurance strategies to ensure compliance with regulatory...


  • Rockville, Maryland, United States Savantage Full time

    Savantage Solutions: A Leader in Federal Systems and Oracle APEX SolutionsWe are seeking a highly skilled Senior Quality Assurance Tester to join our professional services team at Savantage Solutions. As a Senior QA Tester, you will play a critical role in ensuring the integrity, reliability, and performance of our software solutions tailored for federal...


  • Rockville, Maryland, United States Savantage Full time

    Savantage Solutions is seeking a Senior Quality Assurance Specialist to join our professional services team.The ideal candidate will have a strong background in federal systems, federal finance, and Oracle APEX.Duties and Responsibilities:As a Senior QA Specialist, you will play a crucial role in ensuring the integrity, reliability, and performance of our...


  • Rockville, Maryland, United States X Energy, LLC Full time

    Quality Assurance Engineer V, Project QAX Energy, LLC is seeking a highly skilled Quality Assurance Engineer V to join our Quality Assurance team in the role of Project Quality Assurance. This position will be responsible for performing Quality Assurance services in support of X Energy's reactor development projects, including documenting, implementing, and...


  • Rockville, Maryland, United States Savantage Full time

    Savantage Solutions: A Leader in Federal Systems and Oracle APEX SolutionsWe are seeking a highly skilled Senior Quality Assurance Tester to join our professional services team at Savantage Solutions. As a Senior QA Tester, you will play a critical role in ensuring the integrity, reliability, and performance of our software solutions tailored for federal...


  • Rockville, Maryland, United States X Energy Full time

    Job Title: Project Quality Assurance ManagerX Energy, LLC is seeking a highly skilled Project Quality Assurance Manager to join our Safety, Health, Environment, and Quality (SHEQ) team. This role will lead a team of dynamic Project Quality Assurance Engineers in the performance of quality assurance activities supporting X Energy's commercial, nuclear, and...


  • Rockville, Maryland, United States Medix™ Full time

    Job Title: Quality Assurance AssociateAt Medix™, we are seeking a highly skilled Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and integrity of our products.Key Responsibilities:Document Management: Manage the initiation, revision, and distribution of documents in...


  • Rockville, Maryland, United States VDart Inc Full time

    Job Title: Software Quality Assurance Sr. AnalystJob Summary:We are seeking a highly skilled Software Quality Assurance Sr. Analyst to join our team at VDart Inc. The ideal candidate will have a strong background in quality assurance and testing methodologies, with experience in developing and implementing quality control processes.Key...


  • Rockville, Maryland, United States Inotiv Full time

    Job Title: Quality Assurance SupervisorAt Inotiv, we are seeking a highly skilled Quality Assurance Supervisor to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.Key Responsibilities:Oversee all quality assurance functions, including audits,...


  • Rockville, Maryland, United States Medix™ Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Associate to support our document management, materials control, and compliance with Good Documentation Practices (GDP) and GMP standards.Key ResponsibilitiesDocument Management: Manage initiation, revision, and distribution of documents per GDP requirements.Quality Investigations: Assist in...


  • Rockville, Maryland, United States Medix™ Full time

    Job Summary:The Quality Assurance Associate will support the development and implementation of quality management systems, ensuring compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) standards. This role will assist in quality investigations, validation tasks, and audits to ensure product integrity and regulatory...


  • Rockville, Maryland, United States Insight Global Full time

    Job Title: Quality Assurance SpecialistAt Insight Global, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for performing manufacturing oversight of an external contract manufacturing organization producing a Phase Ib clinical CAR-T program.Key...


  • Rockville, Maryland, United States Crimson Technologies Full time

    Electrical Engineer in Quality AssuranceCrimson Technologies is seeking an experienced Electrical Engineer to join our Quality Assurance team. As an Electrical Engineer in Quality Assurance, you will be responsible for ensuring the quality of our electronic components and systems.Key Responsibilities:Functional testing and analysis of errors in electronic...


  • Rockville, Maryland, United States MCMC Full time

    Clinical Quality Assurance CoordinatorWe are seeking a highly skilled Clinical Quality Assurance Coordinator to join our team at MCMC. As a Clinical Quality Assurance Coordinator, you will play a critical role in ensuring the highest quality and integrity of peer review case reports.Responsibilities:Perform quality assurance review of peer review reports,...


  • Rockville, Maryland, United States Crimson Technologies Full time

    We are seeking an Electrical Engineer in Quality Assurance to join our team at Crimson Technologies. In this role, you will be responsible for:Functional testing and analysis of errors in electronic componentsVisual and electronic quality controlCalibration and testing of electronic componentsSupport of factory quality assurance in relation to electronic...


  • Rockville, Maryland, United States International Software Systems, Inc. Full time

    Job Title: Software Quality Assurance EngineerAt International Software Systems, Inc., we are seeking a highly skilled Software Quality Assurance Engineer to join our team.Key Responsibilities:Develop and implement quality control and testing methodologies to ensure compliance with quality assurance standards, guidelines, and procedures.Establish and...


  • Rockville, Maryland, United States MilliporeSigma Full time

    Job Title: Quality Assurance Specialist IIIMilliporeSigma is seeking a highly skilled Quality Assurance Specialist III to join our team. As a Quality Assurance Specialist III, you will play a critical role in ensuring the quality and integrity of our products and services.Key Responsibilities:Investigate and resolve quality-related issues and...


  • Rockville, Maryland, United States Medix™ Full time

    Job Title: Quality Control AnalystMedix™ is seeking a highly skilled Quality Control Analyst to join our team. As a Quality Control Analyst, you will be responsible for ensuring the quality of our products by performing routine analytical testing, entering data into our Laboratory Information Management System (LIMS), and collaborating with our Development...