Job Description

Senior Manager / Associate Director, Clinical Quality Assurance Quality, Singapore Senior Manager / Associate Director, Clinical Quality Assurance - Hummingbird Bioscience (Full-time position – Singapore)
ABOUT HUMMINGBIRD BIOSCIENCE

• Opportunity to work at the cutting edge of drug development

Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes. We harness the latest advances in systems biology and data science to better understand and solve the underlying causes of disease and guide development of our therapeutics.
Enabled by our proprietary Rational Antibody Discovery platform, we discover antibodies against optimal yet elusive epitopes on important targets that have not been successfully drugged, unlocking novel mechanisms of action. We are advancing a rich pipeline of first- and best-in-class precision therapies in oncology and autoimmunity, in collaboration with global partners in academia and industry.
Our highly experienced teams in the US and Singapore span antibody discovery, pharmacology, production and clinical development. Together we aim to accelerate the journey of new drugs from concept to clinical care. For more information, please visit www.hummingbirdbioscience.com, and follow Hummingbird Bioscience on LinkedIn and Twitter.
ABOUT THE ROLE
Join Hummingbird Bioscience on our journey as we transition from an early-stage drug discovery company, to a global leader in drug development. We are looking for an experienced Senior Manager/Associate Director Clinical QA who will report to the Sr Director Quality Assurance and support the development and implementation of the company’s Quality objectives and strategy.
RESPONSIBILITIES (INCLUDING, BUT NOT LIMITED TO)

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• Ensure that clinical trials and clinical trial data are generated, documented, and reported in compliance with the clinical protocol (including any amendments), Good Clinical Practice (GCP) guidelines and all other applicable requirements
• Review/provides input to the development of study-specific documentation including but not limited to the Clinical Study Protocol, Pharmacy Manual, training manuals/materials and other relevant documents before the trial begins
• Quality oversight during selection and qualification of CRO’s
• Provide quality support and expertise during Protocol Deviations, non-compliance issues and Investigations
• Quality oversight of subcontracted activities (CRO, Clinical Sites, Laboratories)
• Prepare and/or review of Clinical SOPs in accordance with international standards
• Contributes to inspection readiness throughout the study lifecycle and support Health Authority Inspections
• Develop risk based GCP audit program
• Perform GCP audits per ICH, clinical protocol and applicable procedures
• Preparing, supporting and following-up on GCP audits performed by consultant auditors, ensuring that execution of outsourced audits is conducted and completed in alignment with HMBD audit processes and standards
• Work closely with all staff to ensure that all aspects of QMS for Clinical Operations is understood, implemented and maintained
• Additional responsibilities as assigned

EXPERIENCE AND QUALIFICATIONS

• Requires a scientific master’s degree, preferably in Biotechnology
• 5-10 years of experience in Clinical Quality Assurance in the bio/pharmaceutical industry is required
• Strong understanding of the drug development process and detailed knowledge of Good Clinical Practice (GCP), ICH Guidelines, including E6 (R2) and current US FDA regulations
• Experience in leading health authority inspections with FDA or MHRA is preferred
• Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines
• Excellent interpersonal skills with the ability to build strong relationships across internal and external partners
• Ability to work independently and with the flexibility to handle workflow in a fast-paced start-up environment
• Excellent verbal and written communication skills with good attention to detail

Are you ready to apply? Join us on our mission to discover and develop important new drugs for cancer and autoimmune disease. Click on ‘Apply for this Job’ to submit your application.
Hummingbird Bioscience is firmly committed to Equal Employment Opportunity (EEO) and to compliance with all Singapore and US federal, state and local laws and/or guidelines that prohibit employment discrimination on the basis of age, race, color, gender, sexual orientation, gender identity, ethnicity, national origin, citizenship, religion, genetic carrier status, disability, pregnancy, childbirth or related medical conditions, marital status, protected veteran status and other protected classifications.