Clinical Quality Assurance Manager

1 day ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Job Summary

Bicycle Therapeutics is seeking a highly skilled Clinical Quality Assurance Manager to support Quality oversight for our development programs, ensuring compliance with applicable GLP and GCP standards and global regulations.

Key Responsibilities
  • Quality Compliance: Partner with global program teams and supporting functions to advise on GLP and GCP compliance, proactively building quality into operational activities.
  • Inspection Readiness: Assist key stakeholders to build inspection readiness to all stages of the development process.
  • Quality Performance Monitoring: Assist with the development and maintenance of key quality indicators and introduce measurement of critical to quality factors, monitor performance against key KPIs both internally and across third parties.
  • Quality Event Management: Ensure monitoring of quality performance indicators, identification of key quality events, escalation of issues and support follow-up activities.
  • Vendor Evaluations and Audits: Support scoping of vendor evaluations and audits, contribute to reports and assist with follow-up on assessment and partner with the business to support the development of CAPAs.
  • Deviation Identification and Reporting: Educate and partner with key stakeholders on deviation identification and reporting as well as risk-appropriate remediation, RCA, and CAPA management.
  • Quality Management System (QMS): Support the development and maintenance of the company QMS and integrated Learning Management System (LMS) and Controlled Document System as appropriate.
  • Training and Development: Serve as a point of contact for QMS-related training assignments for Development colleagues.
Qualifications
  • Relevant Qualification: Relevant qualification within healthcare or Life Sciences or equivalent professional experience.
  • Quality Assurance Experience: Demonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GLP/GCP quality/compliance role.
  • Regulatory Knowledge: Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS).
  • eTMF Requirements: Strong familiarity with eTMF requirements.
  • Deviation Management: Extensive experience managing deviations, RCA, and CAPAs in a GLP/GCP environment.
  • Quality Event Investigations: Experience leading quality event investigations/root cause analysis.
  • Global Drug Development: A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs, and manufacturing.
  • Collaboration and Communication: Highly collaborative, strong relationship-building skills with a high level of integrity.
  • Adaptability and Flexibility: Demonstrated ability to work proactively using solid communication and influencing skills to effectively execute program goals.
  • Organizational Skills: Exhibits flexibility and is a self-starter with a strong attention to detail.
  • Technical Skills: Familiarity with Electronic Document Management (EDM) systems and Microsoft Office suite.
  • Travel Requirements: Position requires both domestic and international travel up to 10% of time.

  • Quality Assurance Lead

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom School of Clinical Medicine - University of Cambridge Full time

    Job DescriptionJob Title: Quality Assurance LeadJob Summary:The School of Clinical Medicine - University of Cambridge is seeking a highly skilled Quality Assurance Lead to join our team. As a Quality Assurance Lead, you will be responsible for providing leadership on all issues related to GCP and ISO laboratory quality management system.Key...

  • Quality Assurance Lead

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom School of Clinical Medicine - University of Cambridge Full time

    Job DescriptionJob Title: Quality Assurance LeadJob Summary:The School of Clinical Medicine - University of Cambridge is seeking a highly skilled Quality Assurance Lead to join our team. As a Quality Assurance Lead, you will be responsible for providing leadership on all issues related to GCP and ISO laboratory quality management system.Key...

  • Clinical Quality Assurance Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Position OverviewThe Manager of Clinical Quality Assurance plays a pivotal role in overseeing quality standards for Bicycle's development initiatives, ensuring adherence to relevant GLP and GCP regulations as well as global compliance requirements. This position is situated within the Development Quality team, reporting directly to the Head of Development...

  • Clinical Quality Assurance Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Position OverviewThe Manager of Clinical Quality Assurance plays a pivotal role in overseeing quality compliance for Bicycle Therapeutics' development initiatives, ensuring adherence to relevant GLP and GCP standards as well as global regulatory requirements. This position is situated within the Development Quality team and reports directly to the Head of...

  • Clinical Quality Assurance Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Position OverviewThe Manager of Clinical Quality Assurance plays a pivotal role in overseeing quality compliance for Bicycle Therapeutics' development initiatives, ensuring adherence to relevant GLP and GCP standards as well as international regulations. This position is situated within the Development Quality division and reports directly to the Head of...

  • Clinical Quality Assurance Lead

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time

    Position Overview The Cambridge University Hospitals NHS Foundation Trust is seeking a Clinical Quality Assurance Lead to oversee the quality assurance processes within the Cambridge Clinical Trials Unit (CCTU). This role is pivotal in ensuring that all clinical trials conducted under the auspices of the Trust adhere to the highest standards of quality and...

  • Quality Assurance Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Cambridge University Hospital NHS Foundation Trust. As a Quality Assurance Manager, you will play a critical role in ensuring the highest standards of quality in our clinical trials.Key ResponsibilitiesDevelop, implement, and maintain systems to assure the quality of...

  • Quality Assurance Manager

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Quality Assurance Manager, you will play a key role in maintaining and monitoring our Good Clinical Practice (GCP) Quality Management System (QMS) to ensure compliance with regulatory requirements and standards.Key...

  • Quality Assurance Manager

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Quality Assurance Manager, you will play a key role in maintaining and monitoring our Good Clinical Practice (GCP) Quality Management System (QMS) to ensure compliance with regulatory requirements and standards.Key...

  • Quality Assurance Manager

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job OverviewWe are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Quality Assurance Manager, you will play a key role in maintaining and monitoring our Good Clinical Practice (GCP) Quality Management System (QMS) to ensure compliance with regulatory requirements and standards.Key...

  • Quality Assurance Manager

    1 week ago

    Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job DescriptionAbout the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Quality Assurance Manager, you will play a key role in maintaining and monitoring our Quality Management System (QMS) to ensure compliance with regulatory requirements and standards.Key ResponsibilitiesDevelop and...

  • Quality Assurance Manager

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job DescriptionAbout the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Quality Assurance Manager, you will play a key role in maintaining and monitoring our Quality Management System (QMS) to ensure compliance with regulatory requirements and standards.Key ResponsibilitiesDevelop and...

  • Quality Assurance Manager

    7 days ago

    Cambridge, Cambridgeshire, United Kingdom CK Group Full time £70,000 - £80,000

    Job DescriptionCK Group is seeking a highly skilled Quality Assurance Manager to join our team in Cambridge. As a leading provider of clinical stage biotechnology solutions, we are committed to delivering high-quality products and services that meet the highest regulatory standards.Key Responsibilities:Maintain and implement a robust Quality Management...

  • Quality Assurance Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Qureight Ltd Full time

    Position Overview: We are seeking a temporary Quality Assurance Manager to oversee our quality and regulatory obligations. This role is essential for ensuring compliance with industry standards and enhancing our quality management system. About Qureight Ltd: Based in Cambridge, UK, Qureight Ltd specializes in expediting clinical trial processes through...

  • Quality Assurance Manager

    7 days ago

    Cambridge, Cambridgeshire, United Kingdom CK Group Full time £70,000 - £80,000

    Job DescriptionCK Group is seeking a highly skilled Quality Assurance Manager to join our team in Cambridge. As a leading provider of clinical stage biotechnology solutions, we are committed to delivering high-quality products and services that meet the highest regulatory standards.Key Responsibilities:Maintain and implement a robust Quality Management...

  • Quality Assurance Manager

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom CK Group Full time £70,000 - £80,000

    Job DescriptionCK Group is seeking a highly skilled Quality Assurance Manager to join our team in Cambridge. As a leading provider of clinical stage biotechnology solutions, we are committed to delivering high-quality products and services that meet the highest regulatory standards.Key Responsibilities:Maintain and implement a robust Quality Management...

  • Quality Assurance Manager

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom CK Group Full time £70,000 - £80,000

    Job DescriptionCK Group is seeking a highly skilled Quality Assurance Manager to join our team in Cambridge. As a leading provider of clinical stage biotechnology solutions, we are committed to delivering high-quality products and services that meet the highest regulatory standards.Key Responsibilities:Maintain and implement a robust Quality Management...

  • Quality Assurance Manager

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom CK GROUP Full time

    CK GROUP is seeking a highly skilled Quality Assurance Manager to join our team in Cambridge. As a Quality Assurance Manager, you will play a critical role in ensuring the quality and compliance of our operations.Key Responsibilities:Maintenance of Quality Management System (QMS): Develop and implement a robust QMS that ensures compliance with all relevant...

  • Quality Assurance Manager

    6 days ago

    Cambridge, Cambridgeshire, United Kingdom CK GROUP Full time

    CK GROUP is seeking a highly skilled Quality Assurance Manager to join our team in Cambridge. As a Quality Assurance Manager, you will play a critical role in ensuring the quality and compliance of our operations.Key Responsibilities:Maintenance of Quality Management System (QMS): Develop and implement a robust QMS that ensures compliance with all relevant...

  • Quality Assurance Manager

    4 days ago

    Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

    Job DescriptionPharma Partners Recruitment Ltd is seeking a highly skilled Quality Assurance Manager to support the Associate Director in ensuring workload is divided and completed successfully. This is an exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets.Key Responsibilities:To play a key role in maintaining...