Manager, Clinical Quality Assurance

4 days ago

Apply Now

Receive Emails with Similar Jobs

Bicycle Therapeutics

WebsiteLinkedInAll Job Openings

Drug Discovery • Phage Display • Peptide Therapeutics • Biotechnology

201 - 500

💰 $175M Post-IPO Equity on 2021-10

Description

• The role of Manager, Clinical Quality Assurance, supports Quality oversight for Bicycle’s development programs, ensuring compliance with applicable GLP and GCP standards and global regulations. • This role is part of the Development Quality group, reporting to the Head of Development Quality. • As an integral member of the quality team, you will serve as a Quality and compliance business partner, engaging with multiple collaborators. • You must be comfortable working independently, managing interactions with and between team members, both internally and externally.

Requirements

• Relevant qualification within healthcare or Life Sciences or equivalent professional experience • Demonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases, with demonstrable experience in a GLP/GCP quality/compliance role • Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS) • Strong familiarity with eTMF requirements • Extensive experience managing deviations, RCA and CAPAs in a GLP /GCP environment • 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. • 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

Benefits

• State-of-the-art 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