Quality Assurance Supervisor for GMP

1 week ago


Durham, North Carolina, United States SpringWorks Therapeutics Full time

SpringWorks Therapeutics is seeking a committed professional to take on the role of GMP Quality Assurance (QA) Manager. This position is crucial for ensuring the quality and regulatory compliance of products across various distribution channels.

Key Responsibilities:

  • Engage with both internal teams and external partners to ensure production schedules are met
  • Oversee the quality unit's review and approval processes for documentation
  • Collaborate with Qualified Persons to facilitate product distribution
  • Monitor stability protocol data and manage expiry dating
  • Lead investigations into deviations and complaints, implementing necessary change controls
  • Participate in compliance audits and assessments of suppliers
  • Establish and maintain performance metrics for Contract Manufacturing Organizations (CMOs)
  • Contribute to the Annual Product Review process
  • Execute other assigned responsibilities as needed

Qualifications:

  • Bachelor's Degree in a scientific or technical field
  • Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or regulated industry
  • Previous experience in managing CMO quality
  • In-depth understanding of quality systems
  • Knowledge of applicable regulations
  • Exemplify the core values of SpringWorks
  • Excellent communication abilities
  • Willingness to travel occasionally and work in an office environment

Compensation:

Competitive salary commensurate with experience and qualifications, along with the potential for an annual bonus. A comprehensive benefits package is also provided.

Equal Employment Opportunity Policy:

SpringWorks is dedicated to ensuring equal opportunities for all employees and applicants, irrespective of background or legally protected characteristics.

GDPR Statement:

Personal data collected during the recruitment process will be processed in a lawful manner and stored securely.



  • Durham, North Carolina, United States SpringWorks Therapeutics Full time

    Job Summary:We are seeking a highly motivated and experienced Quality Assurance professional to join our team at SpringWorks Therapeutics as a Quality Assurance Manager. This individual will play a critical role in ensuring the quality and compliance of our products, working closely with internal stakeholders and external partners to maintain a reliable and...


  • Durham, North Carolina, United States SpringWorks Therapeutics Full time

    SpringWorks Therapeutics is seeking a committed professional to take on the role of GMP Quality Assurance (QA) Manager. This position is crucial for ensuring the quality and regulatory compliance of products distributed by SpringWorks.Key Responsibilities:Engage with both internal teams and external partners to ensure production schedules are metOversee the...


  • Durham, North Carolina, United States Kelly Services, Inc. Full time

    About the RoleWe are seeking a highly skilled GMP Technician to join our team at Kelly Services, Inc.Key ResponsibilitiesConduct quality control tests on products to ensure compliance with industry regulations.Maintain accurate records of test results and communicate findings to management.Follow strict protocols and procedures to ensure compliance with...


  • Durham, North Carolina, United States Piper Companies Full time

    Piper Companies is currently in search of a Quality Assurance Specialist to become part of a cell and gene therapy organization focused on developing groundbreaking AAV platform products aimed at addressing complex diseases. The Quality Assurance Specialist will play a crucial role in the evaluation and endorsement of data within a GMP framework. This...


  • Durham, North Carolina, United States CARsgen Therapeutics Full time

    Position Overview:The Lead Quality Assurance (QA) Operations Expert will play a pivotal role in the daily management of Good Manufacturing Practice (GMP) operations at CARsgen Therapeutics. This position is crucial for ensuring compliance and quality in the production of clinical and commercial products. The selected candidate will provide essential QA...


  • Durham, North Carolina, United States AA2IT Full time

    Qualifications:Actual Title: CQV (Commissioning, Qualification, and Validation) Specialist Qualifications:Educational Background: Bachelor's and/or Master's Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline. An Associate degree may be...


  • Durham, North Carolina, United States SpringWorks Therapeutics Full time

    SpringWorks Therapeutics is seeking a committed professional to assume the role of GMP Quality Assurance (QA) Manager. This position is pivotal in guaranteeing the quality and regulatory compliance of products distributed through various channels.Key Responsibilities:Engage with both internal teams and external partners to ensure production schedules are...


  • Durham, North Carolina, United States MedPharm (formerly Tergus Pharma) Full time

    Job SummaryWe are seeking a highly skilled Quality Control Specialist to join our team at MedPharm (formerly Tergus Pharma). As a key member of our quality assurance team, you will be responsible for reviewing and analyzing data to ensure compliance with regulatory requirements and company standards.Key ResponsibilitiesData Review and Analysis: Review and...


  • Durham, North Carolina, United States Cambrex Corporation Full time

    About the RoleCambrex Corporation is seeking a highly organized and detail-oriented Quality Assurance Document Coordinator to join our team. As a key member of our Quality Assurance team, you will play a critical role in ensuring the accuracy and compliance of our documentation processes.Key ResponsibilitiesOrganize and maintain accurate and up-to-date...


  • Durham, North Carolina, United States Piper Companies Full time

    Piper Companies is currently in search of a Quality Assurance Specialist to become a part of a cell and gene therapy organization that is pioneering advanced AAV platform products aimed at addressing complex diseases. The Quality Assurance Specialist will play a crucial role in the evaluation and endorsement of data within a GMP setting. This position...


  • Durham, North Carolina, United States SBM Management Services Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented GMP Technician/Custodian to join our team at SBM Management Services. The successful candidate will be responsible for maintaining a clean and organized work environment, adhering to strict quality control standards, and ensuring compliance with regulatory requirements.Key...


  • Durham, North Carolina, United States Verista Full time

    About VeristaVerista is a leading provider of innovative solutions and services to the life science industry. Our team of experts works closely with top brands to empower growth and innovation within the scientific community.Job SummaryWe are seeking a highly skilled Validation Engineer - Quality Assurance Specialist to join our team. As a key member of our...


  • Durham, North Carolina, United States MedPharm (formerly Tergus Pharma) Full time

    Position Overview: As a Validation Engineer at MedPharm, you will play a crucial role in delivering validation support for pharmaceutical development and manufacturing processes. This position requires meticulous execution of validation tasks and thorough documentation to ensure compliance with industry standards. Core Responsibilities: Site Master...


  • Durham, North Carolina, United States Insight Global Full time

    Essential Qualifications:Experience in Good Manufacturing Practices (GMP) with a solid understanding of Good Documentation Practices (GDP)Familiarity with gowning procedures for cleanroom environments (grade C/D)Preferred Qualifications:Background in environmental monitoringDaily Responsibilities:We are seeking an Environmental Monitoring Technician to...


  • Durham, North Carolina, United States Carolina Components Group Full time

    Job SummaryJob Title: Quality Assurance SpecialistJob Type: Full-timeLocation: Durham, NCJob Summary: The Quality Assurance Specialist is responsible for ensuring process, material, and assembly compliance to customer specifications, regulatory requirements, and company standards. The individual is responsible for understanding and effectively operating...


  • Durham, North Carolina, United States AICPA Full time

    Software Quality Assurance SpecialistAICPADurham, North CarolinaA highly driven and skilled professional responsible for overseeing, executing, and enhancing the overall quality assurance (QA) results through meticulous planning, control, and execution of testing to support various methodologies including Agile, Scrum, Waterfall, and Hybrid processes. This...


  • Durham, North Carolina, United States Merck Full time

    Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our success is backed...


  • Durham, North Carolina, United States Fujifilm Corporation Full time

    About the RoleFujifilm Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) that partners with clients to deliver innovative solutions for the biopharmaceutical industry. We are seeking a highly motivated Senior QA Technical Specialist to join our team in Research Triangle Park, NC.Key ResponsibilitiesFunction as...


  • Durham, North Carolina, United States Fujifilm Corporation Full time

    About the RoleFujifilm Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) that partners with clients to deliver innovative solutions for the biopharmaceutical industry. We are seeking a highly motivated Senior QA Technical Specialist to join our team in Research Triangle Park, NC.Key ResponsibilitiesFunction as...


  • Durham, North Carolina, United States bioMerieux Inc. Full time

    Production Team Supervisor - Night ShiftLocation: United StatesPosition Type: Unfixed TermJob Function: ManufacturingbioMerieux Inc. is a global leader in the in vitro diagnostics sector, dedicated to providing innovative diagnostic solutions that enhance patient health and ensure consumer safety. With a robust presence in North America, our team comprises...