POSITION: QA Manager
At F-star, we are dedicated to developing next generation immunotherapies to transform the lives of patients with cancer. We develop mAb², a novel class of disruptive bispecific antibody-based therapies that have the potential to overcome tumor resistance and restore anti-cancer immunity and responsiveness.
We are committed to delivering life-changing treatments for the estimated 80% of patients with cancer who currently fail to have a durable response to immunotherapies.
Our wholly owned pipeline shows focused and potent immune activation, with a promising safety profile to date.
F-stars research team is based in Cambridge UK with an expanding footprint in the US from our Hub in Cambridge, Massachusetts to support our clinical stage requirements.
The QA Manager is an individual with great experience within the QA function. They will be responsible for ensuring that GCP/ GCLP related activities are compliant with the appropriate regulations. Including outsourced activities, internal activities and company requirements. The QA manager will work closely with the QA Director and VP, Regulatory affairs to provide operational support, management and guidance primarily in GCP and GCLP.
Establish, develop and manage systems to ensure Quality governance of all internal and outsourced activities in support of regulatory filings and clinical trial conduct. It will also include:
• Development and execution of strategic QA activities in line with corporate goals.
• Provide guidance in application of the QMS to all stakeholders.
• Development and management of QMS overseeing all outsourced activities (including CRO selection and approval, contract auditor management, non-compliance assessment and performance monitoring).
• Experience in development and management of eQMS /DMS systems.
• Assessment and guidance in quality events in relation to clinical development services provided by CRO.
• Development and management of QMS for internal activities impacting regulated activities.
• Maintain ongoing understanding of regulatory expectations and apply pragmatically to company processes.
• Ability to lead and influence diverse teams across a complex multidisciplinary supply chain and clinical network.
• Pragmatic, risk based, solution driven focus.
• Continuous improvement focus.
• Agility as evidenced by flexibility, adaptability, collaboration, initiative.
• Skilled in networking both internally and externally.
• Demonstrable “can do” attitude, essential to a fast-paced biotech environment.
• Ability to work under pressure and prioritise.
• Educated in Bachelor’s degree ideally in science related discipline
• Proven QA experience within a biotech/bio-pharmaceutical company/CRO developing a pipeline of molecules through early to mid-phase clinical trials and beyond.
• Excellent understanding of USA/EU/ICH GCP requirements pertinent to F-star products.
• Extensive experience of operational clinical QA and its practical application in early/mid phase trials.
• Proven experience of managing CRO performance though quality governance, oversight and use of external consultants/auditors.
• Proven experience of application of risk management tools to drive resolution and mitigation.
• Experience in development of risk based data integrity processes suitable for small biotech environment.
• Experience in the design and implementation of formal and informal QA systems within a small biotech environment.
• Experience in implementation of training programmes to support early phase GXP activities.
• Ability to implement QA as a tool for continuous improvement.
What F-star can offer you We get things done, we keep things simple and we’re driven by the science. We’re ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations, team work and perks, which make F-star a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.
• Pension (8% Employer contribution)
• Equity Incentives
• Private Medical Insurance
• Health cash plan
• Life assurance
• 25 days holiday, plus the option to buy 5 days.
• Travel insurance
• Enhanced Maternity, Paternity, Adoption pay
• Flexible working opportunities
To apply for this role, please apply via our website: https://www.f-star.com/about/careers/