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Clinical Quality Assurance Manager
2 months ago
Company 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 and specificity, making them promising candidates for drug development.
The company is actively advancing several clinical trials, including BT8009, a Bicycle Toxin Conjugate targeting Nectin-4; BT5528, targeting EphA2; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist. Additionally, Bicycle Therapeutics is exploring Bicycle Radio Conjugates for radiopharmaceutical applications and leveraging partnerships to extend its technology into other therapeutic areas.
Company Culture:
At Bicycle Therapeutics, our culture is defined by our core values:
- Adventurous: We strive for extraordinary outcomes for our patients.
- Mission-Driven: Our determination fuels our ability to effect change.
- Collaborative: Success is achieved through teamwork.
The Manager, Clinical Quality Assurance plays a crucial role in overseeing quality compliance for Bicycle's development initiatives, ensuring adherence to GLP and GCP standards and global regulations. This position is situated within the Development Quality group and reports directly to the Head of Development Quality.
As a vital member of the quality team, you will act as a compliance partner, collaborating with various stakeholders. The ability to work autonomously while managing interactions with team members, both internally and externally, is essential.
Key Responsibilities- Collaborate with global program teams and supporting functions to ensure GLP and GCP compliance, integrating quality into operational processes.
- Assist stakeholders in preparing for inspections throughout the development lifecycle.
- Develop and maintain key quality metrics, monitor performance against established KPIs, and introduce critical quality factors.
- Oversee quality performance indicators, identify significant quality events, escalate issues, and support resolution activities.
- Assist in vendor evaluations and audits, contribute to reports, and collaborate with the business on CAPA development.
- Educate stakeholders on deviation identification, reporting, and risk-appropriate remediation, including RCA and CAPA management.
- Support functional partners in the development and documentation of CAPAs and effectiveness checks.
- Contribute to the establishment 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.
- Relevant qualifications 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 focus on GLP/GCP compliance.
- In-depth knowledge of GLP/GCLP and GCP regulatory requirements for clinical trial submissions.
- 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.
- Comprehensive understanding of global drug development processes, including preclinical, clinical, regulatory affairs, and manufacturing.
- Excellent relationship-building skills and a high level of integrity.
- Demonstrated ability to communicate effectively and influence stakeholders to achieve program objectives.
- Self-motivated with a keen attention to detail and adaptability to diverse working styles.
- Able to manage multiple tasks and support various teams in complex environments.
- Strong organizational and time management capabilities.
- Familiarity with Electronic Document Management (EDM) systems and Microsoft Office suite.
- Willingness to travel domestically and internationally as required.
- Flexible working arrangements.
- Competitive compensation package, including an annual bonus.
- Comprehensive medical, dental, and vision insurance coverage.
- 401(k) plan with company matching.
- Generous paid time off policy.
- Employee assistance and recognition programs.
- Opportunities for stock options in Bicycle Therapeutics plc.
Bicycle Therapeutics is dedicated to fostering a diverse workforce that reflects the communities we serve. We value diversity and inclusion as key components of our success.
