Associate Director Clinical Quality

Associate Director Quality provides Quality oversight for Bicycles 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 crossfunctional 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 Bachelers 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 selfstarter with a strong attention to detail

Demonstrated ability to adapt working style to those of others for effective communication; able to multitask and support multiple teams with varying levels of complexity

Able to work effectively in highly complex and fastpaced 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

Additional Information :

• Stateoftheart campus environment with on campus restaurant and Montessori nursery
• Flexible working environment
• Competitive reward including annual company bonus 
• Employee recognition schemes
• 28 days annual leave in addition to bank holidays  option to buy up to 5 additional days annually
• Employer contribution to pension (employee does not have to contribute) 
• Life assurance cover 4x basic salary 
• Private Medical Insurance including optical and dental cover. 
• Group income protection
• Employee assistance program
• Health Cash Plan
• Access to company subsidized gym membership.
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. 
• Cycle to work scheme 

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore all qualified applicants will be considered for employment and we do not discriminate on the basis of race religion colour gender sexual orientation age disability status marital status or veteran status.

Remote Work :

No

Employment Type :

Fulltime