Senior Manager of Quality Assurance

4 days ago

Cambridge, Massachusetts, United States eGenesis Bio Full time
Job Title: Senior Manager, Quality Assurance

eGenesis Bio is seeking a highly skilled Senior Manager, Quality Assurance to oversee the GMP cloning operations and Supplier Management Program. This role will be responsible for ensuring compliance to GMP standards of vendors that are part of the Supplier Management Program.

Key Responsibilities:
  • Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of cloning material to be used in clinical studies.
  • Supporting the development of policies, processes, procedures, and controls ensuring that facility operations conform to established cGMP standards and regulatory requirements and guidelines.
  • Supporting the qualification activities associated with the implementation and release of systems, utilities, facility areas (i.e., manufacturing suites), and equipment onboarding/maintenance for the new facility.
  • Supporting day-to-day QA activities associated with manufacturing of cloning materials.
  • Releasing manufacturing suites and batch/product changeovers for continuation of manufacturing activities.
  • Participating in cross-functional teams to resolve quality-related issues impacting manufacturing activities.
  • Reviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations, and CAPAs associated with the operations at the manufacturing facility.
  • Evaluating and approving proposed process changes and improvements in the Manufacturing area, ensuring that appropriate risk assessments are conducted and proposed changes/improvements are consistent with applicable regulatory guidelines.
  • Supporting investigations associated with critical or major manufacturing deviations and providing the necessary guidance to authorize manufacturing operations, as applicable.
  • Authoring, reviewing, and approving internal quality documents (SOPs, investigations, etc.).
  • Participating in supplier qualification audits and supporting internal audits and regulatory inspections, as needed.
  • Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility.
  • Maintaining the QA Operations function in a state of compliance and inspection readiness.
Supplier Quality Management Responsibilities:
  • Managing the Supplier Quality Management Program at eGenesis Bio.
  • Coordinating qualification activities for new vendors and annual audit schedule.
  • Overseeing suppliers of raw materials, reagents, equipment, and services supporting the operations at eGenesis Bio.
  • Working with key stakeholders for the selection, qualification, and management of suppliers.
  • Facilitating risk assessments for new materials or services to be introduced in support of eGenesis Bio's operations.
  • Negotiating and maintaining Quality Agreements between eGenesis Bio and its suppliers.
  • Supporting CMC regulatory submissions, as needed.
  • Defining, monitoring, and reporting quality performance metrics associated with SQM.
  • Ensuring suppliers' readiness for regulatory inspections and/or 3rd party audits.
  • Participating in on-site audits and regulatory inspections, as needed.
  • Managing the Supplier Change Notification (SCN) process and deviations, change controls, and complaints related to the product or services provided by approved suppliers.
Requirements:
  • B.S./M.S. in Life Sciences or related field with 8+ years of experience, including leadership, in GMP Quality Assurance.
  • Experience with QA and GMP compliance in clinical biologics products.
  • Experience providing QA oversight to manufacturing operations in a pharmaceutical/biotechnology environment.
  • 5+ years or supplier/vendor quality management experience in a GxP regulated environment.
  • Ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures.
  • Ability to negotiate and implement Quality Agreements with vendors.
  • Experience with implementation of electronic system(s) to ensure compliance in 21CFR Part 11 and other applicable regulations.
  • Ability to organize and prioritize workload to meet deadlines and company objectives.
  • Ability to work independently and within cross-functional teams.
  • Knowledge of FDA/EMA/ICH regulations and guidelines regarding clinical production and supply of biopharmaceutics.
Leadership Qualifications:
  • Organizational, staff mentorship, and time management skills with attention to details.
  • Ability to negotiate, influence, and work in a cross-functional environment.
  • Handling multiple assignments in a fast-paced environment with changing priorities.
  • Independent development and execution of work plans with minimal supervision.
  • Strong analytical problem-solving, and critical-thinking skills.
  • Excellent written and verbal communication skills with the ability to communicate effectively.

  • Senior Manager of Quality Assurance

    3 weeks ago

    Cambridge, Massachusetts, United States eGenesis Bio Full time

    About the RoleeGenesis Bio is seeking a highly skilled Senior Manager of Quality Assurance to oversee the GMP cloning operations and Supplier Management Program. This role will be responsible for ensuring compliance to GMP standards of vendors and supporting the manufacturing operations, facilities, and systems.Key ResponsibilitiesDeveloping and implementing...

  • Senior Manager of Clinical Quality Assurance

    2 weeks ago

    Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    About the RoleThe Senior Manager of Clinical Quality Assurance will play a critical role in promoting compliance to Good Clinical Practice (GCP) regulations by providing Clinical and Research Development teams with compliance guidance and support related to GCP global regulations and guidelines.Key ResponsibilitiesDevelop and implement clinical quality...

  • Senior Manager of Clinical Quality Assurance

    2 weeks ago

    Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    About the RoleWe are seeking a highly skilled Senior Manager of Clinical Quality Assurance to join our team at Moderna Therapeutics. As a key member of our Quality Assurance department, you will play a critical role in ensuring the compliance of our clinical trials with Good Clinical Practice (GCP) regulations.Key ResponsibilitiesDevelop and implement...

  • Clinical Quality Assurance Senior Manager

    1 month ago

    Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    Senior Manager of Clinical Quality AssuranceChampion adherence to Good Clinical Practice (GCP) standardsOffer expert guidance on global GCP regulationsUtilize GCP knowledge to enhance the auditing frameworkCollaborate with study teams to foster a culture of quality within the organizationCore Responsibilities:Engage in the formulation of clinical quality...

  • Senior Quality Assurance Specialist

    1 month ago

    Cambridge, Massachusetts, United States Aequor Full time

    Senior Quality Assurance SpecialistLocation: RemoteTerms: Contract W2Duration: 12 Months Contract (Potential for Extension)Overview:This role offers a flexible schedule with a requirement for onsite presence at least two days per week.Working Hours: Monday to Friday, 8:00 AM - 5:00 PM (flexible)Ideal Candidate Profile:The ideal candidate will possess over 4...

  • Senior Registered Nurse

    2 weeks ago

    Cambridge, Massachusetts, United States Mass General Brigham Full time

    Job Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled Senior Registered Nurse to join our Quality Assurance team. As a Senior Registered Nurse - Quality Assurance Specialist, you will play a critical role in ensuring the highest quality of care for our patients.Job Summary:The Senior Registered...

  • Senior Registered Nurse

    2 weeks ago

    Cambridge, Massachusetts, United States Mass General Brigham Full time

    Job Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled and experienced Registered Nurse to join our team as a Senior Registered Nurse - Quality Assurance Specialist. This role will be responsible for coordinating clinical quality assurance activities, including the development and review of training...

  • Senior Quality Assurance and Quality Control Building Inspector

    3 weeks ago

    Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    Job SummaryWe are seeking a highly skilled Senior QA/QC Building Inspector to join our team at the Massachusetts Institute of Technology. As a key member of our Facilities department, you will be responsible for ensuring the quality assurance/quality control (QA/QC) system is implemented in an organized and efficient manner.Key ResponsibilitiesDevelop and...

  • Senior Registered Nurse

    7 days ago

    Cambridge, Massachusetts, United States Mass General Brigham Full time

    Job Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled and experienced Registered Nurse to join our team as a Senior Registered Nurse - Quality Assurance Specialist. This role will be responsible for coordinating clinical quality assurance activities, including the development and review of training...

  • Quality Assurance Manager

    11 hours ago

    Cambridge, Massachusetts, United States Quanex Full time

    Quality Assurance ManagerQuanex is seeking a highly skilled Quality Assurance Manager to lead our quality assurance team in Cambridge, Ohio. As a Quality Assurance Manager, you will be responsible for ensuring company compliance with ISO 9001 and all other quality policies and procedures.Key Responsibilities:Manage a team of quality assurance engineers and...

  • Senior Product Quality Assurance Engineer

    3 weeks ago

    Cambridge, Massachusetts, United States Draper Labs Full time

    Job Summary:The Senior Product Quality Assurance Engineer is responsible for partnering with cross-functional teams to develop and implement quality assurance plans, procedures, and processes to meet customer and regulatory requirements. This role requires a strong understanding of quality management systems, including ISO 9001:2015 and AS9100.Key...

  • Quality Assurance Manager

    4 weeks ago

    Cambridge, Massachusetts, United States Innova Solutions Full time

    Job DescriptionJob Summary:Innova Solutions is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring the quality of our products and services, and for leading cross-functional teams to develop and implement quality processes and procedures.Key Responsibilities:Develop and...

  • Senior Registered Nurse

    3 days ago

    Cambridge, Massachusetts, United States Mass General Brigham Full time

    Job Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled and experienced Registered Nurse to join our team as a Senior Registered Nurse - Quality Assurance Specialist. This role will be responsible for ensuring the highest level of quality care is provided to our patients by conducting audits,...

  • Senior Product Quality Assurance Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Draper Labs Full time

    Job DescriptionDraper Labs is seeking a highly skilled Senior Product Quality Engineer to join our team. As a key member of our engineering team, you will be responsible for ensuring the quality of our products and processes.Key ResponsibilitiesPartner with Systems and Design Engineers to develop Mission Assurance plans, procedures, and processes to meet...

  • Incoming Material Quality Assurance Specialist

    7 days ago

    Cambridge, Massachusetts, United States Randstad Life Sciences US Full time

    Job Title: Incoming Material SeniorJoin our team at Randstad Life Sciences US as an Incoming Material Senior, where you will play a critical role in ensuring the quality and compliance of materials procured by our organization.About the Role:As an Incoming Material Senior, you will be responsible for evaluating incoming materials to ensure they meet the...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Cambridge, Massachusetts, United States Amazon Full time

    Employer: AmazonPosition: Quality Assurance Engineer IILocation: Remote options availableKey Responsibilities: Oversee the evaluation of extensive software systems. Develop comprehensive test strategies, design test cases, and promote ongoing enhancements to quality assurance methodologies utilizing cloud services, web technologies, and protocols such as...

  • Senior Quality Assurance Specialist

    1 month ago

    Cambridge, Massachusetts, United States Amazon Full time

    Employer: AmazonPosition: Quality Assurance Engineer IILocation: RemoteResponsibilities: Oversee the evaluation of extensive software systems. Develop comprehensive test strategies, create detailed test scenarios, and promote ongoing enhancements to the quality assurance methodologies utilizing AWS, web technologies such as HTTP, XML, HTML, Load Balancing,...

  • Senior Quality Assurance Specialist

    1 month ago

    Cambridge, Massachusetts, United States Amazon Full time

    Employer: AmazonTitle: Quality Assurance Engineer IILocation: RemoteResponsibilities: Oversee the evaluation of extensive software systems. Formulate testing strategies, design test scenarios, and enhance quality assurance methodologies utilizing cloud services, web technologies, and protocols such as HTTP, XML, HTML, Load Balancing, and DNS. Create and...

  • Senior Product Quality Assurance Specialist

    7 days ago

    Cambridge, Massachusetts, United States Draper Labs Full time

    Job SummaryThe Senior Product Quality Engineer will partner with Systems and Design Engineers to develop Mission Assurance plans, procedures, and processes to meet sponsor program requirements.Key ResponsibilitiesProvide technical assistance and support to customers, suppliers, and employees in resolving issues.Lead and identify improvements of...

  • GCP Quality Assurance Manager

    3 weeks ago

    Cambridge, Massachusetts, United States Meet Full time

    We are seeking a seasoned professional to join our team as a Manager of Quality Assurance in Good Clinical Practice (GCP). This role will provide expertise and guidance on GCP, applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation.Key ResponsibilitiesProvide subject...