QA Director - GCP

A BIT ABOUT US…

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.
We’re an agile, international team with dual headquarters in Cambridge, UK and Cambridge, Massachusetts. We empower our teams to decide where and when they work to deliver our goals.

YOUR ROLE IN OUR TEAM:
The Director QA 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 Director will work closely with QA team members and report directly into the VP, QA and Regulatory Affairs to provide operational support, management, expertise and guidance primarily in GCP and GCLP.

YOUR KEY RESPONSIBILITIES WILL INCLUDE:
Establish, develop and manage systems to ensure Quality governance of all internal and outsourced activities in support of regulatory filings and clinical trial conduct.
• 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).
• Develop operating guidelines/SOPs and common work practices/strategies within the team
• Hands-on experience in development and management of state-of-the-art 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.
• Train, mentor and supervise QA employees, consultants/contractors

A BIT ABOUT YOU:
• 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.
• Maintain a positive team spirit and lead by ethical principles.

YOUR SKILLS, KNOWLEDGE AND EXPERIENCE:
• 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.
• Ability to lead regulatory inspections
• 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 WE CAN OFFER TO 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, socialising 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.

Benefits:
• Pension (8% Employer contribution)
• Equity Incentives
• Private Medical Insurance and Health Cash Plan
• Life assurance
• 25 days paid holiday, plus the option to buy 5 days
• Travel insurance
• Enhanced Maternity, Paternity, Adoption pay
• Agile working opportunities

OTHER DETAILS:
Our Laboratories and office space are based on the Babraham Research Campus, South Cambridgeshire. This role will require some travel to our Cambridge offices.

This is a full-time position working 37.5 hours per week. F-star is proud to fully embrace agile working
which gives you options in how, where and when you get your work done, including flexible working
hours and home working.

Application Instructions: 

NEXT STEPS…
If you feel this role is right for you, we’d love to hear from you.
To apply, please visit our website: https://www.f-star.com/about/careers/ and upload your CV to complete your application. Those that shine brightest will be contacted to discuss the role further, however, we aim to get back to everyone with a response either way.
We may choose to close the role sooner than the application closing date depending on volume of candidates and so we encourage early applications.
If, along the way, you experience any difficulties with applying via our website, please email HR@f-star.com.
We aspire to be a diverse and inclusive workplace and strongly encourage suitably qualified applicants from a wide range of backgrounds to apply.
As part of our compliance in relation to the General Data Protection Regulations 2018 (GDPR) you can find our ‘Candidate Privacy Notice’ on the careers section of website.

Application Closing Date: 
17 May 2022