Clinical Quality Assurance Manager

2 weeks ago

Cambridge, Massachusetts, United States Bicycle Therapeutics Full time
Job Overview

Company Overview:
Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on creating innovative therapies, known as Bicycle molecules, for conditions that lack effective treatments. These molecules are synthetic short peptides designed with small molecule scaffolds, forming loops that enhance their structural stability. This unique design allows for high-affinity and selective binding to targets, positioning Bicycle molecules as promising candidates for drug development. The company is currently advancing several clinical trials, including BT8009, a Bicycle Toxin Conjugate targeting Nectin-4, and BT5528, targeting EphA2, among others.

Company Culture:
At Bicycle Therapeutics, we value a culture of collaboration and commitment, characterized by our core principles:

  • Adventurous Spirit: We strive for exceptional outcomes for our patients.
  • Mission-Driven: Our determination fuels our efforts to make a significant impact.
  • Team-Oriented: Success is achieved through collective efforts.
Position Summary

The Manager of Clinical Quality Assurance plays a crucial role in overseeing quality compliance for Bicycle's development initiatives, ensuring adherence to GLP and GCP standards as well as global regulations. This position is part of the Development Quality team and reports directly to the Head of Development Quality.

Key Responsibilities:

  • Collaborate with global program teams and relevant functions to provide guidance on GLP and GCP compliance, integrating quality into operational processes.
  • Assist stakeholders in preparing for inspections throughout the development lifecycle.
  • Help develop and maintain key quality metrics, introducing measures for critical quality factors, and monitor performance against established KPIs.
  • Oversee the monitoring of quality performance indicators, identify significant quality events, escalate issues, and support follow-up actions.
  • Contribute to vendor evaluations and audits, assist in report generation, and collaborate with the business on CAPA development.
  • Educate stakeholders on deviation identification, reporting, and appropriate remediation, including root cause analysis and CAPA management.
  • Support functional partners in the creation and documentation of CAPAs and effectiveness checks.
  • Assist in the development and maintenance of the company’s Quality Management System (QMS) and integrated Learning Management System (LMS).
  • Act as the point of contact for QMS-related training for Development colleagues.
Qualifications:
  • Relevant degree in healthcare or Life Sciences, or equivalent professional experience.
  • Proven experience in Quality Assurance within the life sciences sector, ideally across all clinical phases, with a strong background in GLP/GCP compliance.
  • In-depth knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions.
  • Familiarity with eTMF requirements and extensive experience managing deviations, root cause analysis, and CAPAs.
  • Strong understanding of global drug development processes, including preclinical, clinical, regulatory affairs, and manufacturing.
  • Excellent interpersonal skills with a high level of integrity and the ability to build strong relationships.
  • Proactive approach with effective communication and influencing skills to achieve program objectives.
  • Ability to adapt communication styles to various audiences and manage multiple tasks in complex environments.
  • Strong organizational and time management capabilities.
  • Familiarity with Electronic Document Management (EDM) systems and proficiency in Microsoft Office.
  • Willingness to travel domestically and internationally as required.
Additional Information:
  • Flexible working arrangements.
  • Competitive compensation package, including an annual bonus.
  • Comprehensive medical, dental, and vision insurance for eligible employees and their families.
  • 401(k) plan with company matching and immediate vesting.
  • Generous paid time off policy.
  • Employee assistance and recognition programs.

Bicycle Therapeutics is dedicated to fostering a diverse workforce that reflects the communities we serve. We believe that diverse and inclusive teams drive innovation and success.

  • Clinical Quality Assurance Manager

    7 days ago

    Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    Job OverviewCompany Overview:Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies known as Bicycle molecules. These fully synthetic short peptides are uniquely designed with small molecule scaffolds that create two loops, enhancing their ability to bind to targets with high affinity and selectivity....

  • Clinical Quality Assurance Manager

    2 weeks ago

    Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    Job OverviewCompany Overview:Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies, known as Bicycle molecules, aimed at addressing unmet medical needs. These molecules are synthetic short peptides structured with small molecule scaffolds, designed to enhance target binding with exceptional affinity...

  • Clinical Quality Assurance Senior Manager

    2 weeks 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 Manager

    2 weeks ago

    Cambridge, Massachusetts, United States Relay Therapeutics Full time

    Position Overview:We are in search of a Quality Assurance leader to play a pivotal role in the development of our Quality function at Relay Therapeutics. This position involves collaboration with Clinical Development teams to manage various external contract partners while actively shaping the Quality Management System as our operations expand. This...

  • Quality Assurance Manager

    5 days 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...

  • Quality Assurance Lead

    5 days 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...

  • Quality Assurance Lead

    2 weeks ago

    Cambridge, Massachusetts, United States Ronin Staffing, LLC Full time

    Job OverviewPosition: Quality Assurance ManagerCompensation: Up to $58/hrContract Duration: 1 year with potential for extensionWork Arrangement: Hybrid - Onsite required at least 2 days per weekSchedule: Monday to Friday, 8 AM - 5 PM (flexible)Essential Qualifications:Proven experience in Project ManagementBackground in medical device industryExpertise in...

  • Quality Assurance Compliance Analyst

    2 weeks ago

    Cambridge, Massachusetts, United States Accuro Full time

    Position: Quality Assurance Compliance Specialist (QUMAS, MyCIMS)Role Overview: This position involves the management and oversight of quality assurance compliance processes, utilizing tools such as QUMAS and MyCIMS.Location: Cambridge, MAContract Duration: 12+ MonthsKey Responsibilities:Implement and maintain data quality management (DQM) practices.Ensure...

  • Quality Assurance Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States SPECTRAFORCE Full time

    Job Title: Quality Assurance Specialist - Quality SystemsLocation: RemoteDuration: Contract PositionThis position is a hybrid role with scheduled work hours Monday to Friday, 8:30 AM to 5:00 PM, requiring onsite presence based on project needs.Key Responsibilities:The Quality Assurance Specialist operates within the Quality Systems division and collaborates...

  • Quality Assurance Specialist

    2 days ago

    Cambridge, Massachusetts, United States Spectrum Industries Full time

    We are seeking a Quality Assurance Specialist to join our team at Spectrum Industries. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our electrical circuits and assemblies.Key Responsibilities:Conduct quality audits and inspections to ensure compliance with industry standardsDevelop and implement quality control...

  • Senior Quality Assurance Leader

    2 weeks ago

    Cambridge, Massachusetts, United States SSi People Full time

    Note: Open to candidates who are either USC / GC / EAD; C2C applications will not be considered. Position: Quality Assurance Manager - Hybrid Role Compensation: $57/hr to $59/hr Key Responsibilities: The Quality Assurance Manager will oversee quality documentation including Deviations, CAPAs, and Change Controls, along with the review and approval of testing...

  • Senior Quality Assurance Specialist

    2 weeks 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...

  • Quality Assurance Lead for Advanced CLIA Laboratory

    2 weeks ago

    Cambridge, Massachusetts, United States Nanobiosym Full time

    Position OverviewNanobiosym is a pioneering organization based in Cambridge, MA, dedicated to developing cutting-edge technologies aimed at combating a wide array of diseases. Founded by an alumnus of MIT and Harvard, Nanobiosym operates at the intersection of physics, nanotechnology, and biomedicine. This rapidly expanding company offers unique career paths...

  • Senior Quality Assurance Specialist

    1 week 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

    2 weeks 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

    2 weeks 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...

  • Clinical Operations Quality Compliance Senior Manager

    1 week ago

    Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    Company OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies known as Bicycle molecules. These fully synthetic peptides are designed to address medical conditions that lack effective treatments. Our research includes advanced candidates such as BT8009, BT5528, and BT7480, all undergoing...

  • Clinical Operations Quality Compliance Senior Manager

    1 week ago

    Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    Company OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapeutic solutions through its unique Bicycle molecules. These fully synthetic short peptides, constrained by small molecule scaffolds, are designed to effectively target diseases that lack adequate treatment options. The company is...

  • Quality Assurance Specialist

    21 hours ago

    Cambridge, Massachusetts, United States Alphanumeric Systems Inc. Full time

    Job DescriptionAlphanumeric Systems Inc. is seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our dynamic team.Key Responsibilities:Quality Assurance Oversight: Ensure that our products meet both Local and Global quality standards by executing all activities following quality and regulatory standards and procedures.Quality...

  • Clinical Operations Quality Compliance Senior Manager

    2 weeks ago

    Cambridge, Massachusetts, United States Bicycle Therapeutics Full time

    Company OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing a unique class of therapeutic agents known as Bicycle molecules. These fully synthetic short peptides are designed with small molecule scaffolds, creating two loops that enhance their structural stability. This innovative design allows for high-affinity...