Clinical Quality Assurance Manager

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Position Overview

The 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 Quality.

As a key member of the quality assurance team, you will act as a compliance partner, collaborating with various stakeholders. The ability to work autonomously while managing interactions among team members, both within the organization and externally, is essential.

Primary Responsibilities

  • Collaborate with global program teams and associated functions to provide guidance on GLP and GCP compliance, proactively integrating quality into operational processes.
  • Assist stakeholders in achieving inspection readiness throughout all phases of the development lifecycle.
  • Support the creation and upkeep of essential quality metrics, introducing the measurement of critical quality factors, and monitor performance against key performance indicators (KPIs) both internally and with external partners.
  • Oversee the monitoring of quality performance metrics, identify significant quality events, escalate issues, and facilitate follow-up actions.
  • Assist in the evaluation and auditing of vendors, contribute to reporting, and collaborate with the business to develop Corrective and Preventive Actions (CAPAs).
  • Educate and partner with key stakeholders on identifying and reporting deviations, as well as managing risk-appropriate remediation, root cause analysis (RCA), and CAPA management.
  • Support functional partners in the development and documentation of CAPAs and effectiveness checks, as needed.
  • Contribute to the development and maintenance of the company’s Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.
  • Act as the point of contact for QMS-related training assignments for Development colleagues.

Qualifications

  • Relevant qualifications in healthcare or Life Sciences or equivalent professional experience.
  • Proven experience in Quality Assurance within the life sciences sector, ideally encompassing all clinical phases, with substantial experience in a GLP/GCP quality/compliance capacity.
  • Familiarity with GLP/GCLP and GCP global regulatory standards for clinical trial submissions (USA, UK & EU), including an understanding of 21CFR Pt. 11 concerning clinical systems (QMS).
  • Strong knowledge of eTMF requirements.
  • Extensive experience in managing deviations, RCA, and CAPAs in a GLP/GCP context.
  • Experience leading investigations into quality events and conducting root cause analyses.
  • A comprehensive understanding of global drug development functional areas, including preclinical, clinical, regulatory affairs, and manufacturing.
  • Highly collaborative with strong relationship-building capabilities and a high level of integrity.
  • Demonstrated ability to work proactively using effective communication and influencing skills to achieve program objectives.
  • Exhibits flexibility and is a self-starter with a keen attention to detail.
  • Ability to adapt communication styles to effectively engage with diverse teams and manage multiple tasks with varying complexities.
  • Able to thrive in complex and fast-paced environments.
  • Strong organizational and time management skills.
  • Familiarity with Electronic Document Management (EDM) systems and the Microsoft Office suite.
  • This position may require both domestic and international travel up to 10% of the time.

Additional Information

  • Modern campus environment with amenities.
  • Flexible working arrangements.
  • Competitive compensation package including an annual company bonus.
  • Employee recognition programs.
  • 28 days of annual leave plus bank holidays, with an option to purchase up to 5 additional days each year.
  • Employer pension contributions without employee contributions required.
  • Life insurance coverage at 4x the basic salary.
  • Comprehensive Private Medical Insurance, including optical and dental coverage.
  • Group income protection plan.
  • Employee assistance programs.
  • Health Cash Plan.
  • Access to subsidized gym memberships.
  • Eligibility for share option grants in Bicycle Therapeutics plc.
  • Cycle to work scheme.

Bicycle Therapeutics is dedicated to fostering a diverse workforce that reflects the communities we serve. We believe that diverse and inclusive teams contribute to a stronger and more innovative organization. All qualified applicants will be considered for employment without discrimination based on race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.

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