Associate Director Clinical Quality

Bicycle Therapeutics

Cambridge, United Kingdom

Job Description

Associate Director, Quality provides Quality oversight for Bicycle’s development programs, ensuring compliance with applicable ICH GCP and GLP standards and global regulations. As an integral member of the Development Quality team, the position serves as a Quality and compliance business partner, engaging with multiple collaborators. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally, leading process improvement initiatives across the R&D organisation. The position will be a member of the Development Quality group, reporting to the Head of Development Quality.

Collaborate with global program teams to ensure protocol, procedural, GCP/regulatory compliance and inspection readiness throughout all stages of product development.

Develop and maintain key quality indicators, metrics and critical to quality factors. Review performance and establish thresholds around performance indicators and associated dashboard capability;
Anticipate, identify, communicate, and manage quality issues to resolution, including escalation to key stakeholders across the business;
Contribute during internal cross-functional meetings to review and document oversight of company Quality initiatives and drive progress;
Support applicable change management pertaining to new and/or evolving global regulations, and anticipate any changes that may impact the development strategies for programs;
Support the review of key clinical trial documents (INDs, manuals, study plans, etc.) for compliance with existing policies and procedures, ICH GCP and applicable global regulatory requirements;
Lead preparation for, and coordination and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections;
Support vendor selection/qualification activities (including but not limited to vendor audits and maintenance of preferred vendor list);
Provide expert quality consultation to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of applicable regulations. Identify and partner with key collaborator functions and business partners as appropriate;
Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.

Qualifications

The position requires a Bacheler’s degree in a biological science or healthcare field;
Demonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GCP quality/compliance role;
Extensive experience of supporting and auditing safety processes for clinical trials;
Knowledge of GCP, FDA, MHRA and EMA regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS);
Knowledge of GLP/GCLP preferred;
Strong familiarity with eTMF requirements;
Experience conducting audits, reviewing audit reports and following up on CAPAs;
Experience leading quality event investigations/root cause analysis;
A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing;
Highly collaborative, strong relationship building skills with high level of integrity;
Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutions;
Demonstrated ability to work proactively using solid communication and influencing skills to effectively execute program goals;
Exhibits flexibility and is a self-starter with a strong attention to detail;
Demonstrated ability to adapt working style to those of others for effective communication; able to multi-task and support multiple teams with varying levels of complexity;
Able to work effectively in highly complex and fast-paced environments;
Strong organizational and time management skills;
Familiarity with Electronic Document Management (EDM) systems and Microsoft Office suite;
Position requires both domestic and international travel up to 10% of time.