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Clinical Quality Assurance Manager
2 months ago
The 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 Development Quality.
As a vital member of the quality assurance team, you will act as a compliance partner, collaborating with various stakeholders. You should be adept at working autonomously while managing interactions among team members, both within the organization and externally.
Key Responsibilities
- Collaborate with global program teams and support 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.
- Help develop and maintain critical quality indicators, implementing measurements for essential quality factors, and monitor performance against key KPIs internally and across third-party entities.
- Oversee the monitoring of quality performance metrics, identify significant quality events, escalate issues, and support follow-up actions.
- Assist in the scope of vendor evaluations and audits, contribute to reporting, and work with the business to facilitate the development of CAPAs.
- Educate and collaborate with key stakeholders on deviation identification and reporting, as well as risk-appropriate remediation, root cause analysis, 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 significant experience in a GLP/GCP quality/compliance role.
- Understanding of GLP/GCLP and GCP global regulatory standards for clinical trial submissions (USA, UK & EU), including knowledge of 21CFR Pt. 11 concerning clinical systems (QMS).
- Strong familiarity with eTMF requirements.
- Extensive experience in managing deviations, root cause analysis, 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 across 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 annual bonuses.
- Employee recognition programs.
- 28 days of annual leave plus bank holidays, with an option to purchase additional leave.
- Pension contributions from the employer.
- Life insurance coverage at 4x the basic salary.
- Comprehensive Private Medical Insurance, including optical and dental coverage.
- Group income protection plans.
- Employee assistance programs.
- Health cash plans.
- 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. Therefore, 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.
